Failure To Biopsy: When Alleged ‘Wound Care Specialists’ Fall Short Of The Standard Of Care

Molly Judge DPM FACFAS

I do not know about you but I continue to find myself wondering who are these so-called wound care specialists who undertake management of wounds but are nowhere to be found when bad wounds take a turn for the worse.

These wound care specialists seem to arise from the depths of the nursing home environments, home care social services personnel and only rarely in wound care centers comprised of board certified physicians. Times seem just fine when the wound care plan expands to include creative combinations of materials and topical agents, and the billing gets processed without interruption.

Once the condition degenerates and clinical progress comes to a swift halt, the environment is not so cheery. When alternate consultations are required to improve the overall health of the patient, speculation arises about the current wound care plan and the feasibility of wound healing comes into question. That is when the wound care gurus become scarce and the in-hospital physicians get stuck holding the ball. This very scenario is reflected in the following case study. See if you can relate to this hospital consultation.

Case Study: When A Presumed Venous Stasis Ulcer Fails To Heal

An 83-year-old male presented to the hospital with a chief complaint of a three-day history of abdominal pain and hematuria.1 The department of podiatric surgery received a consult for evaluation and treatment of a coincident right leg ulceration. The ulcer had been present for approximately three years and the patient related no history of antecedent trauma. The patient had understood the ulcer to be related to his venous stasis.

Since the patient had received care at a veterans care facility, he had been under the care of numerous physicians and had received multiple topical therapies over time. Most recently, in-home nurses had been applying biweekly Unna boots with a wound care specialist assessing the wound every two weeks.
The Unna boot had been helpful in controlling leg swelling and the ulcer was reportedly as small as it had ever been at the time of this admission. The patient denied constitutional symptoms and pain.

The patient’s past medical history includes bladder cancer and a left above-knee amputation (AKA) as a complication of vascular disease and Type I diabetes mellitus. In addition, the patient had a history of myocardial infarction, hypertension, peripheral vascular disease, esophageal strictures and an abdominal aortic aneurysm. The surgical history included an aortofemoral bypass surgery and multiple aortic bifemoral bypass surgeries. The patient admits to social alcohol consumption and a 60 pack a year tobacco history, which he discontinued 12 years prior to admission.

During the physical examination, the use of a 5.07 monofilament on the right lower extremity revealed a generalized peripheral neuropathy with loss of protective sensation beginning at the level of the knee. There were sparse, small, superficial, bluish, tortuous varicosities throughout the right lower leg. Pitting edema was present in trace amounts about the pre-tibial region and the dorsum right foot.

The ulceration was in the central portion of the anterior medial aspect of the right leg. The ulcer had a dry, pale pink granular base with smooth regular borders and a localized blanching erythema about the periphery of the lesion. The ulceration measured 5.5 cm X 2.5 cm X 0.20 cm in its greatest dimensions.

There was no undermining of the adjacent soft tissues and the ulcer did not probe to bone. There was no malodor or drainage, and there were no other dermal defects to the extremity. Muscle strength to the right lower leg was within normal limits. The left AKA was well healed and was free of dermal defects or pre-ulceration.

A soft tissue biopsy was in order. After ensuring sterile prep and drape, 1% xylocaine plain was used to anesthetize the wound periphery. Three 5 mm punch biopsy specimens were obtained. The first two punch specimens came from the 12 o’clock and 3 o’clock positions of the wound periphery with each including a portion of the normal appearing adjacent soft tissue. A final 5 mm punch came from the central aspect of the wound bed. I also obtained superficial wound swabs for culture to identify evidence of significant bacterial colonization or infection. The complete blood count and C-reactive protein were within normal limits.

The microscopic exam revealed a combination of findings that were consistent with a venous stasis ulceration complicated by basal cell carcinoma (BCC). In short, a longstanding wound had been treated for over three years without the benefit of a soft tissue biopsy to determine why this wound had been so recalcitrant in nature.

Key Clinical Characteristics That Suggested A Missed Diagnosis And Need For Biopsy

Curiously, this case presentation included clinical characteristics that were unusual for venous stasis ulceration.

• The borders of the wound were well rounded as opposed to the typical punched out margins usually present in venous stasis ulcers.

• In this patient’s case, the wound bed was free of fibrinous ingrowths or exudates. This is another difference from a typical venous stasis ulceration.

• The granulation bed was pale, which is distinctly different from the meaty red appearance that one often sees with venous stasis ulcers.

There have been similar findings in the literature regarding basal cell carcinomas presenting as chronic ulcerations. However, these differences have only rarely been discussed. The principal dermal appearance of basal cell carcinoma is that of a “pearly” appearing papule or nodule formation. When these ulcers are present, they are often crusted and have rolled, well-rounded borders and are referred to as rodent ulcers. When these ulcers appear about the head and neck, and less commonly in the axillae or inguinal regions, these features are distinctive. However, the same characteristics are not present when the ulcers occur in the lower extremity.

The clinical clues for malignant degeneration of a wound include:

• advanced age of the lesion (often numerous years of therapy before identification);
• abnormal granulation tissue (often bizarre hypertrophic granulation); and
• extension of the wound margins.

The patient in the aforementioned case had undergone treatment for three years, failed numerous regimens of local wound care and had pale colored granulation tissue. These were all unusual characteristics that prompted biopsy.

What The Literature Reveals

In the current literature, 2.2 percent of leg ulcers are actually considered to be skin cancer. Out of these ulcers, basal cell carcinoma is more common (75 percent) than squamous cell carcinoma (SCC).2 A reported 2.4 percent of ulcerations arising from chronic venous stasis will undergo malignant transformation.2

However, the incidence of basal cell carcinoma arising from chronic ulcerations is considered very rare. Interestingly, one study involving 15 patients reports that 25 percent of patients with basal cell carcinoma have a concomitant chronic venous stasis.3 This statistic implies a relationship between venous disease and basal cell carcinoma. Whether the underlying vascular condition is somehow contributory to the malignancy is yet to be determined but chronic inflammation has been suggested as a potential culprit.

Soft tissue biopsy remains the gold standard for the diagnosis of cutaneous malignancy. Since local invasion into bone and lymph nodes has been reported, it is important to identify primary malignancy of the skin as well as wounds at risk for malignant degeneration. Plain X-ray and magnetic resonance imaging (MRI) are able to identify early osteolysis. They are valuable tools in delineating the nature and extent of the soft tissue invasion and or bone involvement. Lymph node involvement, metastases to the lymphatic system, reportedly occurs in only 20 percent of patients.4 However, visceral spread of metastases reportedly may occur without concomitant lymph node involvement.

The prognosis is poor when these malignancies are associated with metastatic disease whether it is found in the lymphatic or visceral systems. This supports the notion that one should biopsy suspicious wounds. Such wounds include those that have been long-standing and recalcitrant to local wound care therapies, those that have a deranged morphology or those with bizarrely hypertrophic granulation tissue. The biopsy can identify harbingers of malignant disease or infection.

Final Thoughts

In this case report, the patient could have had a reduced overall morbidity, reduced risk of infection and decreased need for prolonged wound care had he undergone a biopsy earlier in the course of this condition. The location of the wound was not classic for a chronic venous stasis ulcer as it was nested in the central third of the leg on the medial pre-tibial border as opposed to the medial malleolar surface, which is most typical for these lesions.

The hallmarks of a stasis ulcer in this patient were not impressive as there was no significant evidence of local soft tissue changes such as chronic edema or hyperpigmentation complicated by micro- and macrovascular congestion. Here the most notable features of the wound were the small amount of edema present and the soft tissue atrophy that is predictably found in the pretibial region of a person of advanced age. While our patient was elderly, his medical condition seemed to be complicated by peripheral arterial disease rather than by simple venous stasis and congestion as evidenced by the contralateral limb above-knee amputation.

Although malignant transformation of chronic ulcerations is rare, the gravity of misdiagnosis is costly regarding morbidity and mortality.

In the past decade, there has been an explosion of wound care centers developing across the country. With this rise in wound care centers, there are physicians of various specialties (podiatrists, internists, general surgeons, vascular surgeons, dermatologists, etc.) treating these conditions. It seems intuitive that an increased awareness of this condition would be developing over time given the increased interest and research emerging in wound care.

I think it is fair to say that physicians who may treat chronic wounds and those who call themselves “wound care specialists” should be on top of their academic and clinical game. They should know “when to say when” on wound care and obtain a soft tissue biopsy, alternate physician consultation or both. If a physician fails to refer a patient for a second opinion consultation out of fear that he or she is going to lose a patient, that is beneath the standard of care and we should address it.

References

1. Schnirring-Judge M, Belpedio D. Malignant transformation of a chronic venous stasis ulcer to basal cell carcinoma in a diabetic patient: case study and review of the pathophysiology. J Foot Ankle Surg 2010; 49(1):75-79.

2. Yang D, Morrisson BD, Vandongen YK, Singh A, Stacey M: Malignancy in chronic leg ulcers. Med J Aust 1996;164:718–720.
3. Aloi F, Tomasini C, Margiotta A, Pippione M. Chronic venous stasis: not a predisposing factor for basal cell carcinoma on the leg. A histopathological study. Dermatology 1994;188:91-3.
4. Combemale P, Bousquet M, Kanitakis J, Bernard P: The angiodermatology group of the French Society of Dermatology Malignant transformation of leg ulcers: a retrospective study of 85 cases. J. Europ Acad Derm and Vener (JEADV) 2007;21:935-941.

Editor’s note: The case study portion of this blog was adapted with permission from the article, “Malignant transformation of a chronic venous stasis ulcer to basal cell carcinoma in a diabetic patient: case study and review of the pathophysiology,” which appeared in the January/February 2010 issue of the Journal of Foot and Ankle Surgery.

Comments

Amen! I am a "Wound Specialist" that has been preaching the benefits of soft tissue biopsies for years now. I firmly believe that a great percentage of the recalcitrant leg ulcers that nursing homes and home health agencies are left to deal with are actually undiagnosed malignancies. You seem to be down on long term care facilities and home health agencies but I believe that they try to do the best they can with the resources available to them. Finding a supportive and knowledgeable physician to assist with managing and diagnosing problems like this is no easy task! Depending on the Physician and the staff running a center, Wound care centers are often no better. Let's keep spreading the word and hope that others will catch on.

Clay E Collins, RN, CWOCN, CFCN, CWS, DAPWCA, FACCWS
ccollins@medline.com

VERY well stated Molly!
-Brad

Molly,
You are right on, once again.
The underlying issue you have raised is the 800 lb. gorilla in the room. I have been quite concerned for several years now, knowing how many Providers out there have either paid dues for a certificate to join an organization or have attended a 1-2 day seminar and have the right to be called "wound specialists". I believe that organizations and individuals who dispense/obtain credentials that do not reflect true expertise should at least have their ethics questioned.
I am lecturing at the Midwest Podiatry meeting in March, and one of the points I will be making pertains to the importance of obtaining wound management credentialing through a valid and recognized organization, such as the AAWM.
I would love to have you consider joining my faculty in September for our "Save A Leg, Save A Life" Foundation National meeting.
Please contact me at your convenience. I would love to talk with you.
Best regards,
Des Bell drbell@wounddr.com

In response to the comments submitted by Clay E Collins, RN, CWOCN, CFCN, CWS, DAPWCA, FACCWS I am compelled to provide a point of clarification. I do not want to send the message that I am "down on" nursing home facilities or home health care agencies. On the contrary I work very closely with them every week of my existence. There are however, exceptional situations that occur in these extended care environments that can slip between the cracks. And sometimes, this is due to people who choose to initiate wound management schemes and then simply disappear. Their initial recommendations stay on the chart orders without modification or further patient evaluation over time. This is the case that can slowly turn sour without people realizing it. This comment is geared directly to those who are weak in follow up and this weakness can lead to limb loss. I believe you need to have a high degree of diligence if you choose to manage wounds since many can take months to resolve. I work with out patient facilities and in home nursing agencies and from the majority of them I receive weekly clinical reports from the nursing staff and serologic testing on a regular basis. So despite the fact that I am off site I can still keep my hand on the pulse of the patient. This is not a standard of care that all "wound care specialists" adhere to. And this is the message I was trying to convey. I believe there should be great attention to detail in managing these patients from the start through to the finish. Wound care management is never a one shot fix with a consult. The real work is in the follow up to completion. And if in the end you haven't identified the mechanical dysfunction associated with this wound AND accommodated it with modified shoe gear, orthotic device, brace or a combination of these, then you have only done 1/2 of your work. I encourage all wound care specialists to take a look back and consider how many times that you may have left your work only 1/2 done. It's something that we all need to think about. I truly appreciate your comments Clay. It is encouraging that someone is paying attention to detail. Keep up the good work.

Greetings! And thank you so much for your comments. I truly appreciate your attention to a subject that is so close to my heart in practice. It's funny how such an important aspect of the field of podiatric medicine can be a money maker for those who simply talk the talk but for those of us who actually walk the walk we fall into that category of "yeah, those wound care people, what ever" implying it is some weak branch of the specialty. I am proud of all of the work that I do whether it be elective surgery, reconstruction, trauma or wound care. And frankly, wound care requires the most tedium in getting the job done. You practically need a social worker in your office to appropriately take care of these patients and certainly you need support staff keen on follow up to help you sheppard these people through to fruition. Wound care in todays environment is truly a labor of love as the over head expense, specifically due to time management, can certainly be cost prohibitive. Thank you so very much for your support and keep up the good work.

the most recent comment I posted was in response to Dr. Des Bell's comments from February 20, 2010. Thank you for this clarification

Dr. Bakotic, Thank you so much for your comments regarding wound care management. Since you have the dual background of dermatopathology and podiatry I appreciate your support on this subject. I think it can be summed up by saying there is a need for a higher index of suspicion in managing chronic wounds which should lower the threshold to obtaining wound biopsy. And if you choose to work in wound care you must give this category of your practice more strict attention than usual as these cases often become a matter of life and limb. The fact that you took the time to read this blog is sincerely appreciated. Any more detailed comments that you may have on the subject are not only welcomed but encouraged. Enjoy the spring. Molly

Add new comment