When Not To Use Advanced Wound Care Modalities

Gary M. Rothenberg, DPM, CDE, CWS

The statistics are alarming. The morbidity and mortality associated with lower extremity wounds are high, and we are constantly exposed to new options to help heal our patients. The toolbox for the wound care clinician has expanded exponentially in the past decade and it seems as though we are learning more and more daily about the basic science behind wound care.

   The choice of wound care modalities and products should be based on sound evidence-based medicine and various algorithms exist to help guide therapy. Many of the algorithms will separate patients into low risk and high risk based on existing comorbidities and vascular status. These algorithms also frequently suggest moving away from the standard of care in patients who do not meet the suggested benchmark of appropriate wound healing progress of 50 percent closure at four weeks.1 Many advanced modalities including hyperbaric oxygen treatment and advanced biologics are reimbursed at this period in patients demonstrating a lack of progression toward wound closure. Poorer outcomes are often associated with wounds that fail to close in a timely fashion.

   There are several important studies and acceptance about when to initiate advanced modalities for chronic, non-healing wounds. However, little discussion focuses on the patients we should not use advanced modalities for or, equally important, when to stop utilizing advanced wound care modalities. The focus of this article is to address this clinical dilemma.

Emphasizing Judicious Use Of Advanced Wound Care Products

The treatment of lower extremity wounds with advanced modalities can be very expensive. Many treatments, devices and products have a very high initial cost. However, from a dollar standpoint, we know that wound healing is ultimately cheaper than amputation, not to mention better quality of life.2 Ideally, we would choose advanced modalities based on solid evidence-based medicine, ease of use/access and cost effectiveness.

   The guidelines for initiation of advanced therapies are often clear. As a rule, one may begin using these modalities after standard management without significant progress toward closure. Using biologic skin equivalents as an example, the Apligraf (Organogenesis) product insert notes the product is “Indicated with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration that extend through the dermis but without tendon, muscle, capsule, or bone exposure.”3 The Dermagraft (Shire Regenerative Medicine) product insert states it is “Indicated for use in full-thickness diabetic foot ulcers greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot.”4

   When clinicians use them appropriately, advanced wound care products like biologic skin equivalents can help achieve closure for chronic or difficult to treat wounds. Oftentimes, we utilize these products on our most comorbid patients such as the patient with diabetes and end-stage renal disease or marginal blood flow. Ironically, these are the same patient populations that are often excluded from clinical trials of advanced modalities. There is frequent debate over the question of dosing frequency for biologic skin equivalents and duration of therapy for advanced modalities. Financial implications and restrictions on maximal use pose additional challenges to wound care clinicians.

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