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Evidence-based Treatment Options

If standard diabetic foot ulcer (DFU) treatments do not succeed in adequately reducing the size of the wound or achieve wound closure, advanced treatment options are available. Studies have shown that these therapies can help in wound healing, and their use is included in evidence-based treatment guidelines.

Patients with DFUs should visit their clinicians on a weekly basis. A 2012 study comparing 206 patients with Wagner Grade 1 or 2 DFUs who had weekly vs. bimonthly visits found that weekly follow-up reduced the median time to wound closure by more than 50% (28 days vs. 66 days).1

The week 4 milestone

Several studies have shown that reevaluation 4 weeks after initiation of standard wound healing therapy is clinically useful. These studies demonstrate that if wound size has not decreased by at least 50% by the fourth week of treatment, the likelihood of complete wound healing using the same treatment approach is very low.2-4 The Wound Healing Society guidelines recommend a change in treatment if wound size reduction is not observed at 4 weeks of conventional therapy.5

Advanced treatment

In many cases, standard DFU therapy is not sufficient to heal the wound. The appropriate use of advanced therapies in chronic, nonhealing wounds may prevent limb loss as well as improve quality of life for patients.6 The use of advanced therapies is currently included in evidence-based treatment guidelines and algorithms for DFUs.5

At present, there are only three products approved by the FDA for treatment of DFUs based on the results of rigorous clinical studies:

  1. Apligraf®: bilayered (fibroblast/keratinocyte) cell-based product7
  2. Dermagraft®: human-fibroblast–derived dermal substitute8
  3. Regranex®: platelet-derived growth factor9

The FDA differentiates between wound dressings, which are intended to manage wounds and are classified as noninteractive, and cell-based wound care therapies, which are intended to heal wounds and are classified as interactive. To gain FDA approval for the treatment of DFUs, each of the above products was evaluated in large, randomized, multicenter clinical trials performed in a DFU patient population.

In contrast, many wound dressings and human tissue products receive a 510(k) clearance, which does not require clinical data and for which even preclinical efficacy studies are typically not performed.10

The Centre for Evidence-based Medicine published a “Levels of Evidence” document to help define a process for determining the value of clinical evidence based on its source.11 This pyramid ranks evidence from the highest (Level 1: randomized controlled trials) to the lowest (Level 5: expert opinion or case report). This process provides a guide to clinicians in their decision making to determine the merits of published clinical data.

The Centre for Evidence-based Medicine: Levels of Clinical Evidence

Evidence-based Medicine

Learn more about evidenced-based evaluation and therapy for DFUs. Go >

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References
  1. Warriner RA, Wilcox JR, Carter MJ, et al. More frequent visits to wound care clinics result in faster times to close diabetic foot and venous leg ulcers. Adv Skin Wound Care. 2012;25:494-501.
  2. Coerper S, Beckert S, Küper MA, et al. Fifty percent area reduction after 4 weeks of treatment is a reliable indicator for healing—analysis of a single-center cohort of 704 diabetic patients. J Diabetes Complications. 2009;23:49-53.
  3. Margolis DJ, Hoffstad O, Gelfand JM, et al. Surrogate end points for the treatment of diabetic neuropathic foot ulcers. Diabetes Care. 2003;26:1696-1700.
  4. Sheehan P, Jones P, Casselli A, et al. Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial. Diabetes Care. 2003;26:1879-1882.
  5. Steed DL, Attinger C, Colaizzi T, et al. Guidelines for the treatment of diabetic ulcers. Wound Repair Regen. 2006;14(6):680-692.
  6. Maderal AD, Vivas AC, Zwick TG, et al. Diabetic foot ulcers: evaluation and management. Hosp Pract (Minneap). 2012;40(3):102-115.
  7. Apligraf [prescribing information]. Canton, MA: Organogenesis Inc; 2010.
  8. Dermagraft [prescribing information]. Westpoint, CT: Advanced Biohealing; 2012.
  9. Regranex [prescribing information]. Fort Worth, TX: Healthpoint Biotherapeutics; 2012.
  10. Maderal AD, Vivas AC, Eaglstein WH, Kirsner RS. The FDA and designing clinical trials for chronic cutaneous ulcers. Semin Cell Dev Biol. 2012;23(9):993-999.
  11. Levels of Evidence (March 2009). Centre for Evidence-based Medicine website. www.cebm.net/index.aspx?o=1025. Accessed August 22, 2011.
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