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Foot Infections in the Veterans Health Administration

Posted on September 30, 2015 | Comments Off on Foot Infections in the Veterans Health Administration

by Priya P. Sundararajan DPM, FACFAS1, Barbara M. Porter DPM2, Keith A. Grant Ph.D3, Jeffrey M. Robbins DPM4pdflrg

The Foot and Ankle Online Journal 8 (3): 1

BACKGROUND: Foot infections represent a major health concern in the Veterans Health Administration as they often may lead to limb loss. A majority of these infections are associated with diabetes in the form of diabetic foot ulcers. The diabetic foot infection is associated with a substantial mortality rate and often requires amputation to fully address the nidus of infection.
METHODS: A retrospective chart analysis of all surgeries to treat foot infections in an 18-month period was conducted. Multiple variables- patient location, preventative primary care diabetic foot screenings, routine follow-up by a foot-care specialist, and pre-operative hospital admission- were reviewed and recorded. The data was analyzed using a one-tailed z-test and chi-squared tests. The one-tailed z-test provided a facility-specific data analysis highlighting areas which may benefit from education or assistance in terms of resource allocation. The chi-squared tests reveal generalizable findings regarding the association among primary care diabetic foot screenings, routine follow-up by a foot-care specialist, and the need for pre-operative admission.
RESULTS: Results show an absence of routine follow-up by a foot-care specialist is associated with a statistically higher rate of patients requiring pre-operative admission. Conversely, those patients with routine follow-up required fewer admissions. Though not significant at conventional levels, a higher percentage of patients without the primary care diabetic foot exams also lacked specialty follow-up and necessitated pre-operative hospital admission when compared to patients with the screenings.
CONCLUSION: This study provides an example of methodology reviewing pedal infection-related surgical data to perform effective limb loss prevention in the VHA setting. The generalizable results elucidate the role of the primary care and foot-care specialists in preventative medicine thereby avoiding a hospital admission. The current study suggests that a close, collaborative, patient-centered approach between primary care and podiatry results in better outcomes for patients.

Key words infection, ulcer, diabetic foot, veteran, amputation

ISSN 1941-6806
doi: 10.3827/faoj.2015.0803.0001

Address correspondence to: Priya P. Sundararajan DPM, FACFAS
[1] Director of Podiatry, Wilmington VA Medical Center, Department of Surgery, 302-994-2511, 1601 Kirkwood Highway Wilmington, DE 19805, Priya.Sundararajan@va.gov
[2] Podiatric Surgeon, Wilmington VA Medical Center, Department of Surgery,  302-994-2511, 1601 Kirkwood Highway Wilmington, DE 19805, Barbara.Porter3@va.gov
[3] Assistant Professor, James Madison University Department of Political Science, 540-568-4336, 91 E Grace St., MSC 7705 Harrisonburg, VA 22807, GrantKA@jmu.edu
[4] Director, Podiatry Service Veterans Affairs Central Office; Professor of Podiatric Medicine, Kent State University College of Podiatric Medicine; Clinical Assistant Professor, Case Western Reserve University School of Medicine; 216-791-3800, Louis Stokes VA Medical Center, 10701 East Boulevard Cleveland, OH 44106, Jeffrey.Robbins@va.gov

Foot infections are a major health issue in the Veterans Health Administration as they often jeopardize limb preservation and shorten the patient’s lifespan. A majority of these infections are associated with diabetes in the form of diabetic foot ulcers (DFU). The excessively high 5-year mortality rate associated with patients with diabetic ulcers reaches upwards of 55% [1]. With chronicity, the DFU transitions to bone infection. A festering oste-omyelitis further propagates the pedal nidus of infec-tion resulting in a statistically higher rate of fatal sys-temic disease such as heart attack or stroke [2,3,4]. Consequently, 45% of all patients with a diabetic ulcer require surgery, often times a pedal amputation, to address the nidus of infection and reach resolution of symptoms [5]. Effective preventative care can maximize limb preservation and improve life expectancy.

As the single largest health care system in the United States, the Veterans Health Administration (VHA) is working to meet the complex needs of this dramatically increasing pathology [6]. Primary care providers, podiatric surgeons, general surgeons, vascular surgeons, infectious disease physicians, and wound care nurses are integrated in the treatment of the diabetic foot infection.  In the enormity of the VHA system, providers can be oblivious to the amputation-related statistics that may improve patient outcomes.  A facility-specific assessment allows providers to better understand the events leading up to the amputation and prevent long-term loss of follow-up. Such evidence can inform future strategies to effect better prevention and management of the DFU pathology. The aim of this study is two-fold: 1) to provide an example of a retrospective statistical analysis assessing facility-specific data regarding preventative care and patient outcomes for the benefit of other VHA facilities and 2) to understand the associations among preventative primary care diabetic (PC DM) foot exams, routine follow-up by a foot-care specialist, and pre-operative hospital admission in the VHA setting.

Methods

A retrospective analysis of all surgeries to address pedal ulceration infections between January 1, 2013 and June 30, 2014 were analyzed using one-tailed z-tests and chi-squared tests. The following data was collected for each infection-related pedal surgery: chronological surgery number, chronological patient number, location following the patient, whether a preventative PC DM foot exam was performed, whether the patient’s condition required pre-operative hospital admission, if so the date of admission and the reason necessitating admission, dates of podiatric/surgical/wound care follow-ups the patient had prior to admission or surgery (in the case of no admission), whether the patient was routinely followed or not followed by a foot-care specialist prior to surgery, the date of surgery, and an update regarding the patient’s condition.  Patients who went on to have further limb amputation or endured further complication related to the pedal infection were classified as “poor prognosis.” On the contrary, patients who healed the surgical sites were classified as “healed surgical site.” A description of the data collected is detailed and summarized in Table 1 (see supplement within PDF). Table 1 was analyzed using both one-tailed z-tests (Table 2) to understand facility-specific trends and chi-squared tests (Table 3-5) to examine the association between PC DM foot screenings, routine follow-up by a foot-care specialist, and pre-operative hospital admissions.

The locations from which the patient was referred included the main medical center: Wilmington, surrounding community based outpatient clinics (CBOC) A, B, C, and D, and a nursing home: Community Living Center (CLC). The CBOC facility location was withheld for this publication. Some patients were also referred from the neighboring Coatesville VA medical center.  Patient follow-up data was not readily available from this facility, leading to the exclusion of patients originating from this location from the analysis. The variables (PC DM foot screening, specialty follow-up, admission, and surgery) measured in each facility were compared against each location’s outpatient population share as the base value (Table 2). Additional analysis was also performed to test for dependencies between the variables: preventative PC DM foot exams, specialty follow-up prior to surgery, and pre-operative hospital admissions (Tables 3-5).

The PC DM foot exam is a clinical reminder to be completed by the primary care provider as required by “VA/DoD Clinical Practice Guidelines for the Management of Diabetes Mellitus in Primary Care“ [7]. This reminder ensures that DFU prevention is performed in the primary care sector. This alert is only activated at the anniversary of the patient’s last exam. The alert remains active until the test is performed by the provider at which point the test is de-activated for another calendar year.  If the PC DM foot exam was either not performed or performed within a week of admission or surgery, the exam was considered non-preventative as it served no preventative use once the patient required surgical intervention.

table2

Table 2 One-tailed test comparing the variables measured in each location. Statistical significant findings are in bold.  Down-arrow: Findings are statistically lower than expected. Up-arrow: Findings are statistically higher than expected.

table3

Table 3 Χ2 = 9.9676, p = 0.008.  A statistically significant relationship was found between patients who were not followed by a foot-care specialist and those who were admitted.

The specialty follow-up dates, (as listed in column 5 in Table 1), dictated if the patient was adequately followed by a foot-care specialist (as noted in the adjacent column, column 6). By recording the patients’ last 3 podiatry, surgery, or wound care visits, the investigators were able to assess if the patient had regular follow-ups prior to surgery.  At these visits, all components of the diabetic foot exam were assessed. ADA guidelines suggest that a high-risk patient with a history of amputation or ulceration be seen by a specialist every 1-2 months [8]. To give the patients and providers some leeway, the patient was considered “not followed” if he/she was not seen within 3 months preceding admission or surgery.

table4

Table 4 Χ2 = 2.0563, p=0.152. No statistically significant association was found between patients who did not have a PC DM foot screening and those who were not followed by a foot-care specialist. However a higher percentage of patients who had a PC DM foot exam were also followed by a foot-care specialist. The converse also held true.

 table5

Table 5 Χ2 = 1.6067, p=0.205. No statistically significant association was found between patients who did not have a PC DM foot screening and those who were admitted. However a higher percentage of patients with no PC DM foot exam were admitted compared to patients with a PC DM foot exam. Similarly, most of the patients who were not admitted had a prior PC DM foot screening.

Results

Over the 18-month period, 53 surgeries were performed to treat foot infections on 44 patients. Of these surgeries, 92% were amputations (n=49). Fifty-six percent of the surgeries (n=30) required pre-operative admission. Of the admissions, 95.8% occurred secondary to a foot infection. Only 3.7% of the surgeries were performed on non-diabetic patients (n=2). Forty-four percent of the surgeries were performed on patients who were not followed regularly (<3 months). As a result of foot infection, 7.5% of the pedal surgeries (n=4) were associated with further limb amputation. Five of the surgeries were classified as “poor prognosis”, i.e. the patient was expected to or did lose limb or life and was associated with an unresolved pedal infection. One of these patients, healed the surgical site but subsequently developed severe hypotension, multiple bodily pressure lesions, and died from septic shock.

The one-tailed z-test was used to identify patterns within the variables that were disproportionate to that facility’s population share.  For example, a CBOC serving 15% of the population would be expected to account for 15% of the performed surgeries.  This location-specific analysis demonstrates significantly fewer infection-related pedal surgeries, missing PC DM foot exams, and pre-operative admissions out of the Wilmington facility than would be expected relative to its population share alone (table 1).  In contrast, CBOC A has a significantly higher rate of surgeries, missing PC DM foot exams, and admissions than its population share would suggest.  CBOC C also has more admissions than would be expected, but the number of surgeries and missing PC DM foot exams are not overly disproportionate to its population. Additionally, a higher than expected number of patients were regularly followed in CBOC C prior to surgery. As expected with the typical nursing home population, the CLC has a higher rate of surgery, specialty follow-up, pre-operative admissions, and poor prognosis (60%).  No significant findings were noted in CBOC B and D.

Although the above results are idiosyncratic to the Wilmington medical center and surrounding CBOCs, patterns identified in the aggregate data are generalizable to other VHA systems. Chi-squared tests were used to assess bivariate statistical dependencies in which the presence or absence of one factor influences the rate with which another factor occurs. Analysis confirmed a significant relationship (p=0.008) between patients who were not followed by a foot-care specialist to those who necessitate pre-operative admission (table 2). The observed relationship suggests that high-risk patients who are not routinely followed by a foot-care specialist are more likely to require admission than those who are routinely followed. In fact, the odds of a patient without routine specialty follow-up requiring pre-operative admission is roughly 7.5 times higher than for a followed patient.  No statistically significant relationship was found between patients without PC DM foot screenings and those followed (p=0.152) and admitted (p=0.205) at conventional levels (table 3, 4). However based on percentages, certain trends among these variables seem apparent.  Patients without the preventative PC DM foot screenings tended to also lack follow-up by a foot-care specialist (table 3). The converse also held true. Similarly, a higher percentage of the patients without the PC DM foot exam required pre-operative hospital admission when compared to patients with the screening (Table 4).

The Wilmington facility was associated with statistically fewer infection-related pedal surgeries, fewer missing PC DM foot exams, and fewer admissions than its population share would suggest. This site had fewer adverse events preceding the patient’s surgery and overall fared better in the preventative arena than its CBOC counterparts. These comparatively better outcomes coincided with the most resource-intensive location. As a result, the Wilmington facility assisted in the evaluation in slow or non-healing ulcer patients from the CBOC facilities.

The overlap between CBOC C patients who required surgery and those were admitted was 100%. Moreover, 85% of these surgeries were associated with routine follow-up prior to surgery. These clinical outcomes are suggestive of a lack of efficacy in preventative care in this location.  In CBOC A, 87.5% of surgeries required pre-operative admission, which is significantly higher than would be expected based on its population share. Our solution was to request the foot-care specialists in both CBOC A and C to send all non-healing ulcers with a duration greater than 3 months to Wilmington for evaluation and possible treatment.  In terms of resource allocation, funds for part-time nail technician were requested for CBOC A and C to allow the providers to focus on the higher risk patient population. Additionally, 75% of surgeries out of CBOC A did not have preventative PC DM foot evaluations in the year prior to surgery. Our remedy was to present a facility-wide educational lecture discussing these results and the importance of preventative care in the treatment of DFU.

As expected, patients residing in the CLC were associated with a higher rate of pedal surgery with subsequent limb amputation. With its census of patients who are elderly, immobilized, poorly-vascularized, non-responsive, or systemically complicated, a proper treatment addressing the nidus of infection is often not accomplished. We advised the dedicated CLC wound care nurse who performs weekly wound assessments to consult podiatric or general surgery for new wounds in a timely manner. In addition, the Wilmington wound care nurses have assisted in CLC management and prevention of ulcers.

Discussion

The current study demonstrates the value of collaboration between primary care and specialty care for the treatment of diabetic foot infections in the VHA setting. It is the first in its class to present an example of methodology reviewing pedal amputation and infection-related surgical data for limb loss prevention in the integrated VHA system. This facility-specific research focusing on the circumstances surrounding surgery was conducted to assess the efficacy of preventative measures and effect change to better patient outcomes. As it stands today, data collection and analysis for the purpose of limb preservation is not a routine occurrence in the VHA. The present study uses the data collected to highlight areas of concern and allow implementation of minor changes to effectively manage high-risk diabetic patients.  This methodology can be applied in any facility and may directly impact departmental reorganization, resource allocation, and provider or patient education. The present research is also suggestive of a collaborative relationship between of primary care and foot-care specialists in the management and mitigation of diabetic pedal infections. Prior to this study, the associations of these variables and the need for pre-operative hospital admission were not evident. Our results encourage a partnership between primary care providers and foot-care specialists, including podiatrists, general surgeons, and wound care specialists for early detection of pedal infections, thereby minimizing the need for pre-operative hospital admissions in VHA facilities.

Results indicate CBOC A was associated with a higher rate of surgical interventions for foot infections as well as a lower rate of completed preventative PC DM foot exams. One explanation suggests that fewer providers examining the diabetic foot may lead to undetected foot ulcers, propagate the infection, and result in an amputation. Previous studies have indicated that an increased number of providers examining the diabetic foot resulted in fewer infection-related surgeries [9,10]. A study originating in Sweden demonstrates a lower amputation rate in a region in which patients were referred by a variety of providers in contrast to only referrals from general practitioners, suggesting that the more providers examine the diabetic foot, the earlier infection is treated [9]. Another analysis documents the reduced rate of amputation with early detection of DFU [11]. With the addition of nail technicians, we increase the number of providers examining the diabetic foot. Along with the current study, these investigations illustrate the importance of cross-collaboration between specialties for the early detection and subsequent referral to a specialized diabetic wound care team.

Patients originating from CBOC C were routinely followed prior to surgery but nonetheless required admission prior to surgical intervention. This finding questions the efficacy of preventative treatment received in this facility and is suggestive of the need for education, resources, or further referral to a more specialized team. Similarly, CBOC A was associated with a significantly higher than expected rate of surgeries and admissions. As a hospital admission rather than an outpatient consult usually confers a more serious infection, the presumption that superficial infections are permitted to devolve into deeper more consequential infections is suggested. One plausible hypothesis to explain the higher rate of amputations is that care may not be adequately appropriated for the higher risk patients. Often times, VA podiatric providers are inundated with the lower risk routine nail patients leaving limited resources available for the higher risk patients with ulcers.  The American Diabetes Association task force recommends that high-risk patients (history of ulceration/amputation) be evaluated by a foot-care specialist every 1-2 months, whereas low risk diabetic patients may be evaluated annually by a primary care provider or specialist when necessary [8,12-14]. The addition of a nail technician in CBOC A and C could offload the low-risk patients allowing the providers to focus on the patients at a higher risk for amputation. Moreover, the request for the CBOC facilities to refer their long-standing DFU (> 3months) to the Wilmington facility benefits the CBOC patients. With the Wilmington facility having statistically lower rates of infection-related surgeries and admissions, the patients in the lesser performing facilities are likely to have more positive clinical outcomes with an earlier referral.

The purpose of the study was not necessarily to avoid pedal amputation but to maintain optimal compliance in the events preceding the surgery. Many providers have associated the word “amputation” with a negative connotation as in the case of “amputation prevention.” However evidence-based medicine suggests that patients who avoid amputation and live with chronic osteomyelitis generate a chronic inflammatory response by triggering vascular atherosclerosis [3,15]. A population-based study in a cohort of 23 million studied the relationship between chronic osteomyelitis and coronary heart disease [15]. Once the researchers controlled for age, gender, hypertension, diabetes, hyperlipidemia, and stroke between the control and chronic osteomyelitis cohorts, they found a significantly elevated risk of heart disease- a 95% increase- as compared to the control population [15]. Similar findings were supported in a meta-analysis study evaluating the association of the DFU and cardiovascular mortality [3]. Results showed a substantially increased risk of all-cause mortality, fatal myocardial infarction, and fatal stroke in patients with DFU [3]. These studies are among the growing number of studies that support a timely resolution of the DFU thereby preventing limb loss and increasing life expectancy [3,15-20]. The 30-day mortality rate, cardiovascular outcomes, and pulmonary events associated with a pedal amputation is substantially lower (4x) than below-knee or above knee amputations [17-20]. The goal is not simply to avoid amputation but to recognize the time-sensitivity of reaching a permanent resolution, thereby broadening our perspective to prioritize limb and life preservation.

Results derived from the full dataset suggest that the more high risk patients are followed by foot-care specialists, the less likely the infection will progress to a degree that necessitates admission (table 2). On the patient-level, routine follow-up generally translates to earlier detection of infection or vascular impairment, fewer systemic complications, and lower potential for nosocomial infections. From the facility standpoint, a substantial financial and economic burden can be obviated for each avoidable hospitalization.  Studies show that on average each hospital admission for a pedal amputation costs the facility is approximately $32,000 [21]. This confirms the role of foot-care specialists in the treatment of diabetic foot infection and limb loss prevention as documented in previous studies [22,23]. The present study also demonstrates a positive trend between PC DM foot screenings and follow-up by a foot-care specialist in the VHA setting (table 3). Thus the domino effect between the absence of PC DM foot screening and patients necessitating pre-operative admission is evident. The direct impact of fewer PC DM foot screenings and a higher rate of admission follows a negative trend, though not statistically significant at a conventional level (table 4). The current study, specific to the VHA system, is among the increasing evidence supporting the interdepartmental collaboration to improve patient outcomes and reduce complications [23-25].

Limitations to this study are inherent to any retrospective analysis in that all variables cannot be examined. Regarding the one-tailed z-test, extraneous variables such a provider methodology, patient non-compliance, reason for lacking specialty follow-up, or location-specific resources such as casts, grafts, or personnel assistance were not assessed. However, these extrinsic factors do not diminish current results highlighting areas that may benefit from assistance or modification. This study provides perspective in regards to the number of surgeries rather than the number of patients. Therefore, some patients had repeat infection-related surgeries; this variable was not assessed.  In regards to the chi-squared tests, the variables studied (specialty follow-up, PC DM foot assessments, and pre-operative admission) are generalizable among the VHA facilities nationwide. However, small sample size biases against statistically significant results. For example, the findings regarding PC DM foot screenings and specialty follow-up or admissions are likely to be significant by conventional standards with a larger sample following the current trends. Future research specific to the treatment of pedal infections or DFU may help determine which strategies and wound therapies will improve amputation prevention in this high-risk population. We encourage all VHA facilities to retrospectively assess the variables affecting patient outcomes and study the associations between these variables to better patient outcomes.

In summary, by focusing on the situations surrounding the surgical treatment of pedal infections or amputation, each facility is able to perform self-assessments to improve patient care. We believe that only with a self-investigative approach can limb preservation be legitimately pursued. By assessing relevant variables we demonstrate the value of foot-care specialists and primary care providers in the treatment of diabetic foot infections in a VHA facility. This patient-centered approach facilitates earlier detection of infection, mitigates systemic complications, decreases the economic burden to the facility, and ultimately minimizes limb loss.  With interdepartmental collaboration, we are able to prioritize limb preservation for veterans who have already sacrificed so much.

References

  1. Moulik PK, Mtonga R, Gill GV: Amputation and morality in new-onset diabetic foot ulcers stratified by etiology. Diabetes Care 26(2): 491-4, 2003. (PubMed)
  2. Bortoletto MS, de Andrade SM, Matsuo T, Haddad MC, González AD, Silva AM: Risk factors for foot ulcers- a cross sectional survey from a primary care setting in Brazil. Prim Care Diabetes 8(1):71-6, 2014. (PubMed)
  3. Brownrigg JRW, Davey J, Holt PJ, Davis WA, Thompson MM, Ray KK, Hinchliffe RJ: The association of ulceration of the foot with cardiovascular and all-cause mortality in patients with diabetes: a meta-analysis. Diabetologia 55(11):2906-2912, 2012. (PubMed)
  4. Subramaniam B, Pomposelli F, Talmor D, Park KW: Perioperative and Long term morbidity and mortality of above-knee and below-knee amputation in Diabetics and Nondiabetics. Anesth Analg 100:1241-7, 2005. (PubMed)
  5. Apelqvist J, Larsson J, Agardh CD: Long term prognosis for diabetic patients with foot ulcers. J Intern Med 233(6):485-91, 1993. (PubMed)
  6. Miller DR, Safford MM, Pogach LM: Who has diabetes? Best estimates of diabetes prevalence in the Department of Veterans Affairs based on computerized patient data. Diabetes Care 27 (Suppl. 2):B10–B21, 2004. (PubMed)
  7. VA/DoD Clinical Practice Guideline for the Management of Diabetes Mellitus in Primary Care 102-114, 2003. (Link)
  8. American Diabetes Association: Consensus Development Conference on Diabetic Foot Wound Care. Diabetes Care 22(8): 1354-60, 1999. (PubMed)
  9. Apelqvist J, Larsson J. What is the most effective way to reduce incidence of amputation in the diabetic foot?. Diabetes Metab Res Rev 16(Suppl 1):S75–S83, 2000. (PubMed)
  10. Larsson J, Apelqvist J, Agardh CD, Stenström A. Decreasing incidence of major amputation in diabetic patients: a consequence of a multidisciplinary foot care team approach?. Diabet Med 12(9):770-6, 1995. (PubMed)
  11. McCabe CJ, Stevenson RC, Dolan AM. Evaluation of a diabetic foot screening and protection programme. Diab Med 15:80–84, 1998. (PubMed)
  12. Apelqvist J, Bakker K, Van Houtum WH, Nabuurs-Franssen MH, Schaper NC. International consensus and practical guidelines on the management and the prevention of the diabetic foot. Diabetes Metab Res Rev 16: S84-92, 2000. (PubMed)
  13. Boulton AJ, Armstrong DG, Albert SF, et al. Comprehensive foot examination and risk assessment: a report of the task force of the foot care interest group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists. Diabetes Care 31(8): 1679-85, 2008. (PubMed)
  14. Frykberg RG, Armstrong DG, Giurini J, Edwards A, Kravette M, Kravitz S, Ross C, Stavosky, Stuck R, Vanore J. Diabetic foot disorders: a clinical practice guidelines. J Foot Ankle Surg 45(5 Suppl):S1-66, 2006. (PubMed)
  15. Hsiao LC, Muo CH, Chen YC, Chou CY, Tseng CH, Chang KC. Increased risk of coronary heart disease in patients with chronic osteomyelitis: a population-based study in a cohort of 23 million. Heart 100:1450-1454, 2014. (PubMed)
  16. Schofield CJ, Libby G, Brennan GM, MacAlpine RR, Morris AD, Leese GP. Mortality and Hospitalization in Patients After Amputation: A comparison between patients with and without diabetes. Diabetes Care 29(10):2252-2256, 2006. (PubMed)
  17. Lavery LA, Van Houtum W, Armstrong DG, Harkless LB, Ashry HR, Walker SC. Mortality following lower extremity amputation in minorities with diabetes mellitus. Diabetes Res Clin Pract 37:41–47, 1997. (PubMed)
  18. Lavery LA, Hunt NA, Ndip A, Lavery DC, Van Houtum W, Boulton AJ. Impact of chronic kidney disease on survival after amputation in individuals with diabetes. Diabetes Care 33(11):2365-2369, 2010. (PubMed)
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  20. Mwipatayi BP, Naidoo NG, Jeffery PC, Maraspini CD, Adams MZ, Cloete N. Transmetatarsal amputation: three-year experience at Groote Schuur Hospital. World J Surg 29(2):245-8, 2005. (PubMed)
  21. Peacock JM, Keo HH, Duval S, Baumgartner I, Oldenburg NC, Jaff MR, Henry TD, Yu X, Hirsch AT. The Incidence and Health Economic Burden of Ischemic Amputation in Minnesota, 2005-2008. Prev Chronic Dis 8(6):A141, 2011. (PubMed)
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Intraepidermal Eccrine Adenocarcinoma of the Foot: A case report

Posted on July 1, 2009 | Comments Off on Intraepidermal Eccrine Adenocarcinoma of the Foot: A case report

by Natalie G. Cunningham, DPM1 , Robert S. Crockett, DPM2 , Donald Kushner, DPM3  

The Foot and Ankle Online Journal 2 (7): 1

Intraepidermal Eccrine Adenocarcinomas (IEA) are rare malignant tumors derived from the eccrine sweat glands of the skin. IEA occur equally in adult males and females between 50-80 years of age. Race is not a factor in prevalence of IEA. The incidence on the sole of the foot is unknown. The majority of IEA are associated with local aggressive metastasis. Therefore, Mohs microsurgery is now recommended, due to higher frequency of recurrence with surgical excision. Long term observation is indicated to ensure eradication of lesions, and for observation and treatment of any recurrence or metastases.

Key Words: Intraepidermal, eccrine, adenocarcinomas, eccrine porocarcinomas, sweat duct, Mohs, foot ulcer.

This is an Open Access article distributed under the terms of the Creative Commons Attribution License.  It permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. ©The Foot and Ankle Online Journal (www.faoj.org)

Accepted: June, 2009
Published: July, 2009

ISSN 1941-6806
doi: 10.3827/faoj.2009.0207.0001

In 1956 Pinkus, et al., were the first to describe tumors exhibiting features of the epidermal sweat duct. [4] Evidence concerning the intraepidermal portion of the eccrine duct was initially presented in 1939 by Pinkus. [4] Intraepidermal Eccrine Adenocarcinoma (IEA) is classified with several other lesions that share similar pathological form, including: eccrine acrospiroma, eccrine porocarcinoma, malignant eccrine poroma and malignant hidroacanthoma simplex, among others. They vary in size from 1 – 10cm, averaging 2.5cm in most pedal cases. [2] Usually arising in skin of the head, neck and upper extremity, the majority of lower extremity lesions are found on the soles of the foot. [6] However, it is rare that these lesions are primary foot lesions. [2]

A benign form of IEA is eccrine acrospiroma, which can transform to a malignant form, especially in inveterate lesions. [1] The lesions of IEA can take on various morphology most often appearing as a single nodule or plaque, resembling plantar wart, ulcerated polypoid mass, or eroded plaque. [3,6] Biopsy is standard for diagnosing IEA. When IEA were first diagnosed it was thought that wide surgical excision was the treatment of choice, but recurrence rates were high. Now, Mohs microsurgery has become the standard treatment for IEA.

Case Report

In March 2004, an 85 year old African American gentleman presented to the Louis Stokes VAMC emergency department with a complaint of neck, hip, knee, leg and back pain. The patient’s past medical history included diabetes, hypertension, and cataract. Additionally, earlier in the month, the patient had been diagnosed with prostate cancer with osteoblastic metastatic disease in the ninth left rib, L2 and L5.

Other diagnoses included OA and the patient was given the proper follow-ups with geriatrics, urology and podiatry. In June 2004, he began visits to the LSVAMC podiatry department. The patient presented with a painful lesion on plantar right heel at the site of a puncture wound treated many years prior.

The lesion had initially been treated as a plantar wart at a private Cleveland area hospital. This treatment was continued for 5 months until the lesion became ulcerative with deep fissuring. The patient reported that the lesion had been present since 1990, and had varied in appearance throughout this time.

It was felt that this was likely due to frequent debridement as part of the wart treatment. The patient recalled that the lesion had been biopsied in 2003 at a local hospital and was found to be “negative.” Radiographs and magnetic resomance imaging (MRI) were obtained at that time which showed no sign of cortical defect or foreign bodies. MRI revealed a 1cm flat superficial skin lesion under the heel of the right foot without abnormal enhancement. No spread into the subcutaneous tissue, bony involvement or foreign body was seen. (Figs. 1A – D)

 

Figures 1A, 1B, 1C and 1D  MRI of right foot was taken with and without contrast consisting of the  following  technique.  Sagittal STIR, sagittal T1-weighted, coronal T1-weighted, axial PD/T2-weighted, axial T1 fat-sat, and sagittal T1 fat-sat were obtained without contrast. Following gadolinium intravenous administration, sagittal and axial fat-sat T1-weighted images were obtained. (A-D)  There is a subtle area of abnormal signal within the skin at the  heel of the right foot.  It measures 1.2 1.1 x 0.4 cm in anterior posterior (AP),  transverse, and craniocaudal dimension, respectively.  It is slightly hyperintense on both T1 and T2-weighted images compared to the adjacent skin.  The skin/dermal layer appears to be displaced deeply by this lesion.  There is no extension or connection into the subcutaneous tissue or bony structure seen. (C,D)

By this time surgery had been discussed with patient on several visits and seemed to be established but in December 2004 the patient became unsure of surgery. The patient did not return to clinic until March 2005. The lesion previously measured 0.8 x 0.6cm in July 2004.

Throughout this time the lesion varied in size and was still fissured, but now with 2 areas of hypergranulation, circumferential maceration and yellowish drainage (Figs. 2A and B). He related that it was common for this lesion to drain occasionally. At this time, the lesion was still present and painful. He related that he had been using Regranex® (Systagenix Wound Management, Johnson & Johnson) for the “ulcer.” He refused biopsy and surgery a second time. For the next 10 months the lesion was treated as a wart or as an ulcer, depending on its appearance at the time of the visit.

 

Figures 2A and 2B  Clinical appearance of Intraepidermal eccrine adenocarcinoma exhibiting a hypertrophic lesion at the plantar right heel with deep fissuring and minimal granular tissue seen between fissures. Surrounding skin is macerated with yellowish hue secondary to dressing.  (A)  A close up view of the lesion is shown. (B)

During this time the lesion varied in size ranging from 4mm x 5mm to 1.5 cm x 1.0 cm in diameter. In March 2006 the patient returned to clinic stating that he had had the lesion removed by an outside hospital, but the lesion had returned again. The patient was advised about our concern for possible malignancy in this long standing wound. In August 2007, the patient finally agreed to biopsy. A 4mm punch biopsy was performed in podiatry clinic.

The biopsy revealed intraepidermal eccrine adenocarcinoma (Fig 3A – D). The dermatology dept at LSVAMC was consulted. Due to the unusual nature of the lesion, the patient was presented at the local University Hospital Multidisciplinary Conference.

 

 

Figures 3A – D  Histological slide which diagnosed Intraepidermal Eccrine Adenocarcinoma.  Large parakeratotic remnants cap a surface of atypical cells. (A,B)  Nodal metastasis, glandular pattern, with atypical nuclei, mitosis, and compressed vascular tissue stroma. (C)  Individual tumor cells appearing mildly pleomorphic with cytological atypia. (D)

It was felt that Mohs surgery would be best treatment for the patient, due to the location and pathology of the lesion. Prior to surgery, various studies were performed to ensure that the patient had no existing metastases. No cervical, supraclavicular, axillary, inguinal or popliteal adenopathy was revealed.

In December 2007, the procedure was performed under local anesthesia. Mohs microsurgery was performed utilizing frozen tissue sections and Hemoxylin and Eosin (H&E) stains, as follows: The 1st stage of surgery was immediately undertaken by debulking the tumor, and a peripheral and deep margin was excised around the clinically obvious tumor. (Fig. 4A) Hemostasis was established, and a pressure dressing was applied.

The tissue was divided into 2 sections, color coded, and mapped. The sections were then frozen, cut, and stained by the histotechnician. Microscopic examination of the entire tissue margin revealed no residual carcinoma. There was minimal blood loss. All options regarding reconstruction were presented to the patient. Finally, the wound was the reconstructed with graft repair. (Fig.4B)

 

Figures 4A and 4B   Initial intraoperative debridement of lesion with scribed mapping of technique to take place. (A)  Post operative appearance of lesion with overlying graft which has been sutured into place. (B)

The patient had an initial 2 week follow-up and then once a month. In August 2008 the patient returned for the final appointment. Observation of the right heel revealed a 4mm healed surgical site with mild hyperpigmentation of the graft site. The patient was discharged after this visit. He is now more than 17 months post excision and there has been no recurrence of the lesion. Patient is still seen by the Podiatry department for diabetic foot care and by the Dermatology department for annual evaluation of site.

Discussion

IEA are rare malignant tumors derived from the eccrine sweat gland. They have been reported in 1 of every 13,000 specimen acquired in pathology laboratory. [8] IEA have tendency to arise in various parts of the body, usually in the trunk and lower extremity, but not uncommonly in the upper extremity, head, neck, or scalp. In a study by Pontone, 46 foot cases with various eccrine cancer types were described. It was found that the most common tumor site for the lower extremity was the sole of the foot. [2] IEA have no distinctive prevalence in sex, age or racial background. Studies vary in regards to sexual predilection, and most will agree that there is no true predisposition to gender. [1,9] Similar to gender, racial background used to be unclear as well. Earlier studies found a higher occurrence in patients of caucasian decent. In 2001, Peterson reported the first case of adnexal carcinoma in an African American. [10]

Since then most research relates no predilection for race. Unlike sex and racial background, studies agree that 50-80 years of age is when most eccrine tumors arise. While it is difficult to determine who is at increased risk of developing IEA, it is thought that immunocompromised patients develop appendageal tumors more frequently than those who are not. [11]

It is thought that IEA and other similar eccrine carcinomas arise from pre-existing benign lesions. [12] As revealed in this case study, IEA are sometimes misdiagnosed due to similarity in appearance to plantar wart, ulcerated polypoid mass or eroded plaques.

If the lesion is inveterate and prior treatment modalities have failed, biopsy of the lesion should take place immediately. In this case report the biopsy was not initially done because the patient had a biopsy a year prior at an outside hospital and it was found negative for malignancy. Foreign body could not be ruled out due to patient history; therefore, x-ray and MRI were obtained. X-ray, although not the gold standard in diagnosing soft tissue/glandular tumors, was useful in this case because it eliminated the diagnosis of metastasis to bone and helped rule out foreign body.

MRI played a similar role, but it also allowed visualization of the depth of the tumor in reference to invasion into dermis and subcutaneous tissue. Some eccrine carcinomas appear as a solid enhancing nodule on MRI although not true in this case. Sweat gland tumors should be considered in the differential diagnosis of a subcutaneous mass regardless of signal charachteristics.13 Biopsy is standard for diagnosis of IEA and similar lesions. A 4mm punch biopsy was taken of the lesion in this case. Biopsy gives a section representation of the lesion and determines if it is benign or malignant in nature. All eccrine tumors have a similar histological appearance. Atypical parakeratotic cells, nodal metastasis in glandular pattern, mitosis, compressed vascular stroma, and pleomorphic tumor cells were evident in determining that the lesion was IEA.

IEA, like other eccrine porocarcinomas, have metastatic potential and can often recur if not treated properly. If metastasis does occur, the prognosis is poor, with mortality rates of 75-80%. [14,15] In this case it was determined that Mohs microsurgery would be the procedure of choice. However, some studies have reported radiation therapy and wide surgical excision as an alternative procedure. In a study by Ryan [5], 3 cases of malignant eccrine porocarcinomas were identified one of which was treated with radiotherapy. Treatment was uniformly successful in treating the primary skin lesion, but after a year the lesion still managed to cover a significant amount of surface area on the trunk. The management of patients with metastatic malignant eccrine poroma is difficult.

It has proven resistant to many chemotherapeutic agents and radiotherapy has not generally been effective. [16] Pontone’s study relates a follow-up for a mean of three years with no recurrence or metastasis. The majority of studies agree that Mohs microsurgery is the treatment of choice.

Mohs microsurgery is a unique microscopic technique that has become the standard of care for removal of certain cutaneous carcinomas. Mohs allows precise marginal control by the use of horizontal frozen sections. It is performed in stages that are determined by the size and depth of the lesion. On average it usually takes 3 stages before no signs of cancer remain. The IEA in the above case was removed by one stage only.

Mohs surgery is performed by dermatologic or oncologic surgeons, and a pathologist. First the external portion of the lesion is debrided. When this layer of skin is removed it is divided into sections. The surgeon color codes each section with dyes and makes reference marks on the skin, hence mapping out the surgical site. Mapping is done prior to injecting with local anesthetic because of possible distortion of the site and anatomic landmarks of the lesion after infiltration. The under surface and the edges of each section are then microscopically examined for evidence of remaining cancer. If cancer is found, its location is then marked and the patient will have to return to the minor procedure room to remove another layer of skin, but now it is more precise to where the cancer remains. The process will continue until no evidence of cancer remains.

Another benefit of Mohs microsurgery is that it only removes tissue consisting of cancer cells; therefore the maximum amount of healthy tissue remains intact. Mohs is cost effective in comparison to radiation therapy or wide surgical excision in the operating room. At the completion of the procedure, the resulting defect is immediately reconstructed. A graft is usually placed on the site and sutured into place (Fig 4B), or it is allowed to heal via secondary intention.

Mohs, like any surgery, does have complications which can be considered as minor. These include post operative hematoma, seroma, wound dehiscence, flap necrosis, graft failure, infection, contact dermatitis to antibiotic ointments or dressing materials, excessive granulation formation, keloid and/or hypertrophic scar formation, hyperpigmentation and/or hypopigmentation, and recurrence of the tumor. [17] The possibility that a lesion will recur cannot be ruled out, but Mohs microsurgery has been proven to have a much lower rate of recurrence than any of other surgical treatments. Since eccrine tumors can be considered as rare, a comparative treatment study has not been created.

In conclusion, IEA are rare and those in the lower extremity are most often found on the sole of the foot. They should not be excluded as a differential diagnosis with lesions such as plantar warts, hypertrophic/hypergranular ulcer or polypoid mass is noted on the skin, especially, if present for long periods with no improvement. The standard for diagnosis is biopsy. Once the pathologist relates intraepidermal adenocarcinoma as a diagnosis immediate consultation to the dermatologist is recommended. The majority of IEA are associated with local aggressive metastasis. Therefore, Mohs microsurgery is now mandated, due to higher frequency of recurrence with surgical excision. Patients should also be advised that long-term follow-up care is needed.

References

1. Kauderer C, Clarke HD, Fatone CT. Malignant eccrine acrospiroma: A case study. J Am Podiatr Med Assoc 85: 116 – 117, 1995.
2. Pontone M, Potter GK, Berlin S J, Reiss PA, Levin RS, Mantell GM, Gleitman D, Kennelty JM, Simon SD, Kahn JB, Havens RT, Semer LC. Malignant eccrine neoplasms of the Foot. J Foot Ankle Surg 33: 486 – 491, 1994.
3. Cowden A, Dans M, Militello G, Junkins-Hopkins J, VanVoorhees A S. Eccrine porocarcinoma arising in two African American patients: distinct presentations both treated with Mohs micrographic surgery. International J Dermatol 45: 146 – 150, 2006.
4. Pinkus H, Rogin JR, Goldman P. Eccrine poroma: tumour exhibiting features of the epidermal sweat duct unit. Arch Dermatol 174: 511 – 521, 1956.
5. Ryan JF, Darley CR, Pollock DJ. Malignant eccrine poroma: report of three cases. J Clin Pathol 39:1009-1104, 1986.
6. Huet P, Dandurand M, Pignodel C, Guillot B. Metastasizing eccrine porocarcinoma: report of a case and review of the literature. J Am Acad Dermatol 35: 860 – 864, 1996.
7. Dzubow LM, Grossman DJ, Johnson B. Chemosurgical Report: Eccrine Adenocarcinoma-Report of a Case, Treatment with Mohs Surgery. J Dermatol Surg Oncol 12: 1049 – 1053, 1986.
8. Mehregan AH, Hasimoto K, Homayoon R. Eccrine adenocarcinoma- a clinicopathologic study of 35 cases. Arch Dermatol 119: 104 – 114, 1983.
9. Emanuele Ferri, Gaetano Antonio Iaderosa, Ernico Armato. Metastasizing eccrine porocarcinoma of the nose: case-report with immunohistochemical study and review Of the literature. The Internet Journal of Otorhinolaryngology. 7 2: 2008.
10. Peterson CM, Ratz JL, Sangueza OP. Microcytic Adnexal Carcinoma: First reported case in an African American man. J Am Acad Dermatol 45(2):283 – 285, 2001.
11. Harwood CA, McGregor JM, Swale VJ, Proby CM, Leigh IM, Newton R. High frequency and diversity of cutaneous appendageal tumors in organ transplant reciepients. J Am Acad Dermatol 48: 401 – 408, 2003.
12. Shaw M, McKee PH, Lowe D, Black MM.. Malignant eccrine poroma – a study of 27 cases. Br J Dermatol 107: 675 – 680, 1982.
13. Allan R, Reier AR, Ashman CJ, Miles L. MR imaging appearance of plantar eccrine acrospiroma (Sweat gland tumor). Am J Roentgeno 179:1079-80, 2002.
14. Harvell JD, Keroehmann RL, LeBoit PE. Eccrine or apocrine poroma? Six poromas with divergent adnexal differentiation. Am J Dermatopath 18: 1 – 9, 1996.
15. Affleck AG, Bong JL, Ostrounova MA, Leach IH, Perks AG, Varma S. Eccrine porocarcinoma. Dermato Online J 12(1):17.
16. Harari PM, Shimm DS, Bangert JL, Cassady, JR. The role of radiotherapy in the treatment of malignant sweat gland neoplasms. Cancer 65:1737 – 1741, 1990.
17. Mooney, M., Parry, E. Mohs Micrographic Surgery. EMedicine by web MD; updated Feb 21, 2007.

Address correspondence to: Donald Kushner, DPM, Dept. of Surgery, Podiatry Division, Louis Stokes Cleveland VA Medical Center, 10107 East Blvd. 112W, Cleveland, OH 44106

1  Submitted while 3rd year resident, Dept. of Surgery, Podiatry Division, Louis Stokes Cleveland VA Medical Center, Cleveland, OH
2  Submitted while 3rd year resident, Dept. of Surgery, Podiatry Division, Louis Stokes Cleveland VA Medical Center, Cleveland, OH
3  Dept. of Surgery, Podiatry Division, Louis Stokes Cleveland VA Medical Center, Cleveland, OH.

© The Foot and Ankle Online Journal, 2009

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The Use of Marigold Therapy for Podiatric Skin Conditions

Posted on July 1, 2008 | Comments Off on The Use of Marigold Therapy for Podiatric Skin Conditions

by Robert A. Hadfield, BS1, Tracey C. Vlahovic, DPM2 , M. Tariq Khan, PhD (Lond), BSc (Pod Med), BSc (Hons), MChS, DFHom (Pod), FBAHChP PFLS3

The Foot & Ankle Journal 1 (7): 1

Marigold therapy has been used for over 30 years in the United Kingdom and has been evaluated by numerous randomized double-blind placebo-controlled studies for various skin issues on the lower extremity. Various species of marigold are naturally anti-viral, keratolytic, and anti-inflammatory when applied topically to the affected area. Marigold therapy offers a non-invasive and gentle treatment for difficult to treat plantar verruca, painful hyperkeratotic lesions, and inflamed bursa secondary to hallux abducto valgus.

Key words: Phytotherapy, Marigold, verrucae, foot ulcer, Tagetes species, Calendula species, hyperkeratotic lesions, bunion, bursitis

This is an Open Access article distributed under the terms of the Creative Commons Attribution License.  It permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. ©The Foot & Ankle Journal (www.faoj.org)

Accepted: May 2008
Published: July 2008

ISSN 1941-6806
doi: 10.3827/faoj.2008.0107.0001

Two marigold species, Tagetes and Calendula, have been used for centuries as herbal remedies for various ailments. (Figs.1ab) Phytotherapy, or the use of plants for their medicinal properties, is the basis for most pharmaceutical products. In particular, the marigold has an interesting history as both a topical and an oral remedy.

 

Figures 1ab  The Tagetes (a) and Calendula (b)  marigold species.

Marigold therapy was first described in the podiatric literature as a treatment for plantar hyperkeratotic lesions in 1980. [1] The Tagetes species of marigold has been found to be strongly keratolytic. The keratolytic and anti-inflammatory properties of Tagetes in the treatment of verrucae and hyperkeratotic lesions have been well documented in the literature. [2-8] Tagetes has also been described as a treatment for carbuncles and eye infection in India as well as for joint pain and muscular spasms in Brazil and Mexico. [9,10] In addition to being a treatment for verruca, this species has also been used in the treatment of allergic contact dermatitis as well as radiation dermatitis associated with breast cancer therapy. [11,12]

In contrast, the English pot Marigold (Calendula species) has been described in the treatment of cuts, wounds and ulcerations as early as 1838. [13] More recently, anti-tumor and anti-oxidant properties of Calendula species have been established and utilized in researching treatments for various cancers. [14,15] This species has also been found to have hepatocytoprotective properties in the treatment of CCI4 poisoning as well as anti-microbial properties.16-18 In recent years, investigators outside the United States have studied the properties of the Calendula species in healing diabetic foot ulcerations. [19,20]

This article will review the literature for the use of Tagetes and Calendula species on the most common podiatric conditions treated and will show their usefulness as an effective and non-invasive therapy. The chemicals found in the multiple Tagetes species described will demonstrate keratolytic, anti-viral, and anti-inflammatory properties. The use of the Calendula species of marigold will be described, including a case study demonstrating its use in non-healing ulcerations.

Hyperkeratotic Lesions

Painful hyperkeratotic lesions, arising from both mechanical stressors and boney deformity, are extremely common podiatric conditions. Treatments range from conservative debridement, change of shoe gear, orthotics, and topical keratolytics to surgical correction of the underlying deformity.

A marigold based paste has been used successfully as topical therapy for these lesions for many years in the United Kingdom. (Figs. 2, 3)

Figure 2   Painful plantar hyperkeratotic lesions prior to marigold therapy.

Figure 3  Clearance of lesions after four treatments; one month after initial therapy.

Davidson reported M. Taufiq Khan’s work with the Tagetes species and its ability to inhibit cell activity in the stratum corneum. [1] A chemical analysis of Tagetes isolated tagetone, d-limonene, acimene, linalyl-acetate, linalol 9.8%, and other terpenes. [21] Tagetone acts as a catalyst to inhibit the rapid production and transmission of keratinocytes. [22,23]

Tagetes’ effect on podiatric skin, bone, and nail conditions was further described by Khan and White followed by numerous randomized, double-blind placebo controlled studies on those conditions. [24]

In 1996, Tagetes erecta was used for a double blind placebo controlled study for thirty patients with painful plantar hyperkeratotic lesions. [4] They were separated into three groups: marigold therapy with an aperture pad, marigold therapy without an aperture pad, and placebo marigold therapy with aperture pad. The placebo paste was formulated to look and feel identical to the active paste but with no active chemical ingredients. In the semi-compressed felt aperture pad, a paste of fresh plant combined with isopropyl alcohol was applied by the podiatric practitioner once a week for four weeks over the painful lesions. The patients wore the poultice dressing for a week and returned weekly for lesion debridement by the practitioner. At the end of the treatment period, patients received either active or placebo tincture and ointment to use on the test area at home for four weeks.

The active paste group with a pad showed a significant decrease in hyperkeratotic lesion width, length, and pain when compared to the placebo group.

The active paste group with pad versus the active paste group without pad also had a significant difference in width, length and pain showing that the aperture pad had helped to offload the lesions as well as compartmentalize the marigold paste to the affected area. Reducing the trauma at the painful hyperkeratosis site is believed to decrease cytokine production thus decreasing kertinocyte production. This coupled with the natural keratolytic property of Tagetes (containing tagetone among other chemicals) proved to be a promising therapy, which could be used prior to custom molded orthotic therapy or as an alternative to surgical correction.

The keratolytic property of Tagetes was further explored in several published case studies. [5,13,25] Patients receiving a similar therapy as previously described reported pain relief after 48 hours of the first dressing application. Interestingly, the patients who used the home therapy and orthotic control after the initial eight week period had no recurrence of the lesions after one year.

Plantar Verrucae

Plantar verrucae cause patients to seek treatment when the lesions become painful or do not resolve on their own. Treatments range from topical to surgical and are typically painful. Marigold therapy can also be added to the many topical treatments for verrucae. (Figs. 4,5)

Figure 4  Recalcitrant plantar verruca prior to marigold therapy.

Figure 5  Clearance of the lesion after four treatments.

Forty patients were randomly placed into one of four groups; active, placebo, active with pad, and pad only with no paste. [26] Patients were treated twice a week for two weeks and then used home therapy consisting of the tincture and ointment for four weeks. The lesion surface area pre-treatment and post-treatment was analyzed with a wound mapping system. Results showed that the active group had a significant difference in appearance, pain, and size compared with the placebo group.

Additionally, the proposed antiviral property of Thuja occidentalis, a member of the conifer tree family, was studied using thirty randomly selected patients. [27] Patients were chosen with lesions older than eighteen months. An extract containing T. occidentalis was applied daily for three weeks and followed for six months after initial treatment. Ninety percent of patients had resolution of their lesion after one month from the initial treatment. At six months, the same number of patients had no recurrence. After the assessment, a double blind placebo controlled study was done. Results showed 80% of the active group had resolution while the placebo group had just 33% resolution. [27]

A combination of the Tagetes and Thuja into a paste has been used extensively since the separate controlled studies were completed. A small case study showed the usefulness of the paste in immunocompromised patients with mosaic type verrucae. [28] All of the patients were HIV positive with detectable viral loads and verrucae that did not respond to conventional treatment. Four applications of the combination paste eradicated the verrucae in two of the three patients. (Figs. 6,7) Although further research is warranted in this population, it is a hopeful outcome for a non-invasive treatment.

Figure 6    Immunocompromised patient with mosaic plantar verruca prior to therapy.

Figure 7  Clearance of mosaic verruca after four treatments.

Soft Tissue Inflammation Associated with Hallux Valgus

The tissue underlying the prominent medial eminence seen in hallux valgus can become inflamed and be the source of a patient‘s discomfort. This bursitis is often treated with injections, padding, and shoe gear change. For patients that do not want surgery to correct the underlying boney deformity, marigold offers a gentle alternative to decrease inflammation and pain associated with hallux valgus. (Figs. 8,9) There is strong evidence that a particular species of Tagetes exerts anti-inflammatory action towards acute and chronic conditions. [29]

Figure 8  Patient with significant bursitis pain over bunion prior to marigold therapy.

Figure 9  Decrease of erythema and inflammation at bunion site after therapy.

A randomized double-blind placebo controlled study utilized sixty patients with either bilateral or unilateral inflammation was performed. [30] Twenty patients with bilateral inflammation were randomly placed into one of two groups: active paste with aperture pad and placebo paste with protective pad. Forty patients with unilateral bursitis were randomly placed into similar groups with an identical treatment plan. All patients followed the paste and pad therapy with either an active or placebo home therapy consisting of tincture and ointment spray to use on the area daily. Soft tissue swelling at the medial eminence of the bunion was assessed using calipers pre and post treatment. Patients in both of then active groups had complete relief of pain after eight weeks and a 35% reduction in soft tissue swelling at the bursitis site. In the placebo group showed minor reduction in pain which was most likely due to the presence of the aperture pad. However, their original symptoms returned at a week 4 when the patients started the placebo home therapy.

Marigold’s ability to reduce bursitis inflammation was further studied in a group of 45 patients with unilateral pain. [22] Patients were randomly placed into five groups: six groups with active marigold paste (each group had various extracts in organic solvents) and aperture pad and three groups with placebo without aperture pad.

After a similar treatment plan described in the previous study, Group A (active paste in ethanolic extract with pad) had 100% in level of pain (using the visual analogue pain scale) while Group G had 30% reduction in their level of pain.

Both of these studies support the combined use of marigold therapy with a protective aperture pad for patients with painful medial eminence bursitis who are not surgical candidates or do not wish to undergo surgical correction.

Superficial Ulceration

Khan states, in his 1982 publication in World Medicine on the uses of various species of marigolds, that Calendula species promote healthy granulation tissue. [13] There are currently clinical projects underway at the School of Pharmacy at the University of London on these properties of Calendula. There was a single reported case of use in a diabetic ulcer, by Khan in the United Kingdom, using the formulation that was utilized in the following case study.

A larger study, by Duran, et al., was published in Serbia in 2005, using Calendula extract on 34 venous stasis ulcerations. [20]

They reported a statistically significant difference in reduction of total wound area compared with the control (p<0.05), showing an overall decrease of 41.71% in the experimental group compared with 14.52% in the control group. They conclude that application of Calendula extract significantly increases epithelization in chronic venous ulcerations.

This study by Duran, et al., lends scientific credence to the use of Calendula extract as a treatment to decrease the healing time of chronic ulcerations. However, randomized control studies have to yet to be completed.

Case Study

A thirty year old Caucasian male presented with concern of an ulcer on the anterior right leg. The superficial wound was over the site of an external fixator pin tract scar, which had occurred fifteen years earlier. The injury was a result of a blunt blow on a coffee table, shearing off the hypertrophic scar. The patient reported bleeding globally across the lesion at the time of injury. He denied a personal or family history of family diabetes, hypertension, coagulopathy and peripheral vascular disease.

Treatment initiated by the patient consisted of triple antibiotic ointment and a bandage. The patient reported that approximately one week after the injury, in the course of cleansing the wound, eschar that had previously formed self-debrided, and the wound appeared as it did on the day it was sustained. The same treatment was resumed, with a similar course of routine healing. Two weeks following the injury, a similar loss of eschar was duplicated. The second event led the patient to seek treatment.

On initial examination, the patient had a 2.5 cm x 2 cm x 0.5 cm circular lesion over the crest of the anterior tibia in the central one third of the leg. The lesion had a mixed granular and fibrotic base, with mild surrounding erythema and no edema (Figure 10).

Figure 10  Anterior leg ulcer on intital presentation prior to marigold therapy.

No undermining was present, and there was no maceration of the wound edges. There was no purulence or malodor. The scars from the other pin tract sites were also examined and were labeled hypertrophic.

The patient received a regimen of marigold therapy for the wound. The medication used was the HTS 087 Tincture and Ointment. (Marigold Footcare Ltd, UK) The therapy regimen consisted of a combination of the tincture and ointment placed in an aperture pad which was then covered with medical tape and gauze over the lesion for three consecutive days. The same regimen was followed every other day after the initial three day period for two weeks.

The patient related no pain or discomfort for the duration of the treatment. Reduction in wound size (approximately 25%) was noted 48 hours after marigold therapy was initiated. (Fig. 11)

Figure 11  The lesion with decreased erythema and increased granulation tissue 48 hours after therapy.

Eschar information with a decrease in wound size was noted on subsequent dressing changes for six days afterwards. The directions for application were followed until epithelization was noted, which was accomplished in eight days. Complete resolution was obtained in approximately four weeks. (Fig. 12)

Figure 12  The resolved lesion.

The complex nature of this wound, having formed over a pre-existing scar and in a traditionally difficult-to-heal area anatomically, caused a delay in wound healing despite the patient’s uncomplicated medical history. The wound’s recalcitrance in healing warranted additional therapy than just antibiotic ointment and patience.

Discussion

It should be noted that over the counter and/or health food store creams and preparations of marigold do not have the same effect as the previously discussed studies show. The extracts used for the controlled and case studies were researched and developed by M Taufiq Khan and M Tariq Khan over thirty years. They developed specific extracts that are directly applied by the podiatric physician to the patient: an anti-viral paste (for verruca), an anti-inflammatory paste (for bursitis and tendonitis), a keratolytic paste (for hyperkeratosis), and an anti-fungal paste (for nails). The patients then continue with home therapy that consists of tinctures and ointments with the same properties. These products were only recently introduced to the United States. The second author was the first United States podiatric physician to become certified in the use of the marigold products from Marigold Footcare, Ltd., and the Royal London Homeopathic Hospital, London, UK and will be able to certify (in conjunction with the Hospital) other podiatric physicians in the future. In order to ensure appropriate use of the extracts, certification will only be available to podiatric physicians and is required for both the usage and purchasing of the products. Further research will continue into using the extracts on genodermatoses, onychomycosis, and other podiatric conditions.

Conclusion

The superficial ulceration case study and immunocompromised patients with verruca case study combined with studies performed outside of the United States show the promise of the continued investigation of marigold therapy as a treatment for various podiatric conditions. Marigold therapy has consistently been shown to provide gentle, non-invasive treatment that allows patients a painless alternative treatment.

References

1. Davidson L., “Marigold rediscovered: a cure for callosities,” Therapy. Pg 1, 1980.
2. Khan M., et al., “Homeopathic treatment of common foot conditions,” British Journal of Dermatology Nursing. 1: 20-23, 2003.
3. Khan M., et al., “Marigold Treatment of foot conditions,” Dermatology in Practice. 10 (3): 28-30, 2002.
4. Khan M., et al.,“Podiatric Treatment of hyperkeratotic plantar lesions with marigold Tagetes erecta,” Phytotherapy Research. 10: 211-14, 1996.
5. Khan, et al., “Treatment of plantar hyperkeratosis with homeopathic podiatry,” Podiatry Now. Dec. 502-505, 2000.
6. Talhouk R., et al., “Anti-inflammatory bioactivities in plant extracts,” J Med Food. 10 (1): 1-10, Mar 2007.
7. Herold A., et al., “Antioxidant Properties of some hydroalcoholic plant extracts with anti-inflammatory activity,” Roum Arch Microbiol Immunol. 62(3-4): 217-227, 2003.
8. Fuchs S., et al., “Protective effects of different marigold (Calendula officinalis L.) and rosemary cream preparations against sodium-lauryl-sulfate-induced irritant contact dermatitis, “ Skin Pharmacol Physiol. May 20, 2005.
9. Hernandez F. “Historia de las plantas de nueve Espana.” Mexico Irmenta Universitaria. 1: 90-91, 1942.
10. Caius J. “The Medical and Poisonous Compsoitae of India, “ J Bombay Natural History Society. 41: 90-91, 1940.
11. Pommier P., et al., “Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer, “ J Clin Onco.l 22 (8) ; 1447-1453, Apr 15, 2004.
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Address correspondence to: Tracey C. Vlahovic, DPM
Associate Professor, Temple University School of Podiatric Medicine, Philadelphia, Pa. 19107
email: traceyv@tample.edu

1Fourth year student, Temple University School of Podiatric Medicine, Philadelphia, Pa. 19107.
2Associate Professor, Temple University School of Podiatric Medicine, Philadelphia, Pa. 19107.
3Deputy Director of Moeopathic Podiatry, The Marigold Clinic, Royal London Homeopathic Hospital, London, UK.

© The Foot & Ankle Journal, 2008

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