SLR - May 2015 - Payal Patel

A Prospective, Randomised, Controlled, Multi-Centre Comparative Effectiveness Study of Healing Using Dehydrated Human Amnion/Chorion Membrane Allograft, Bioengineered Skin Substitute or Standard of Care for Treatment of Chronic Lower Extremity Diabetic Ulcers

Reference: Zelen CM, Gould L, Serena TE, Carter MJ, Keller J, Li WW.  A Pospective, Randomised, Controlled, Multi-centre Comparative Effectiveness Study of Healing Using Dehydrated Human Amnion/chorion Membrane Allograft, Bioengineered Skin Substitute or Standard of Care for Treatment of Chronic Lower Extremity Diabetic Ulcers. Int Wound J. 2014 Nov 26.

Reviewed By: Payal Patel, DPM
Residency Program: Botsford Hospital

Podiatric Relevance: The population diagnosed with diabetes has been an upward, growing trend with approximately 25 percent of those developing a diabetic foot ulcer. With these wounds being slow to heal secondary to other co-morbities and a high recurrence rate, advanced wound care treatments have been highly researched and implemented as one of the most beneficial treatment options. The purpose of this study was to compare the efficacy of utilizing a human amnion/chorion membrane allograft or a bioengineered skin substitute verses standard wound care treatments.

Methods: A prospective, randomized, controlled, parallel group, multi-centre clinical trial was performed to compare the healing outcomes of Apligraf, Epifix (dehydrated amnion/chorion membrane) or standard wound care in diabetic patients with chronic lower extremity ulcers. Patients with Type 1 and Type 2 diabetes with lower extremity ulcers were eligible for the study.  Patients were excluded from the study if a 20 percent reduction in size of the ulcer was noted after a two-week period of daily dressing changes with offloading and weekly sharp debridements. Inclusion criteria included patients who had an ulcer for greater than four weeks, which was unresponsive to standard wound care treatment, Hemoglobin A1C less than 12 percent, and adequate circulation to the affected extremity. Patients were seen once a week for wound care for up to 12 weeks. For patients receiving Apligraf or Epifix, graft was applied every week after adequate debridement. All wounds were offloaded utilizing a cam walker.

Results: A total of 60 subjects were qualified for the study. Twenty randomized patients were given a weekly application of Apligraf. Twenty randomized patients were given a weekly application of Epifix. Twenty randomized patients were given standard wound care. The rates of healing were compared at four weeks and at six weeks.Complete healing at four and six weeks respectively, was achieved by 35 percent and 45 percent of patients receiving Apligraf, 85 percent and 95 percent of patients receiving Epifix, and 30 percent and 35 percent of patients receiving standard wound care. Mean wound size reduction was seen greatest in the patients receiving the Epifix application. Median healing times were 13 days for patients receiving Epifix, 49 days for patients receiving Apligraf and 49 days for patients receiving standard wound care.

Conclusion: This study was able to show the effectiveness of the Epifix with a quicker rate of complete healing in a shorter amount of time, when compared to Apligraf and standard wound care. The authors also pointed out the cost effectiveness of the Epifix when compared to the Apligraf. Although this prospective randomized study had a small patient population and did not consider any comorbidities which may have altered healing, it showed to be a viable option in outpatient wound care. It should also be noted that this study was funded by Epifix.

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