SLR - June 2019 - Casey Lewis
A Confirmatory Study on the Efficacy of Dehydrated Human Amnion/Chorion Membrane (dHACM) Allograft in the Management of Diabetic Foot Ulcers: A Prospective, Multicenter, Randomized, Controlled Study of 110 Patients from 14 Wound Clinics
Reference: Tettelbach W, Cazzell S, Reyzelman AM, Sigal F, Caporusso JM, Agnew PS. A Confirmatory Study on the Efficacy of Dehydrated Human Amnion/Chorion Membrane (dHACM) Allograft in the Management of Diabetic Foot Ulcers: A Prospective, Multicenter, Randomized, Controlled Study of 110 Patients from 14 Wound Clinics. Int Wound J. 2019;16(1):19–29.
Scientific Literature Review
Reviewed By: Casey Lewis, DPM
Residency Program: Beth Israel Deaconess Medical Center, Boston, MA
Podiatric Relevance: Diabetic foot ulcerations present a challenge to healthcare providers, a significant personal burden to patients and a vast cost to the healthcare system. Delayed wound healing along with infection, and often subsequent osteomyelitis, and recurrence are daunting challenges. The extensive impact of these wounds has providers pursuing alternative treatment modalities to care for our patients. As human amnion products have shown promise in breaking wound stagnation and are more readily available through preservation techniques, the body of evidence validating their usefulness in wound healing expands. The following study is one piece of supporting evidence, which examines the efficacy of dehydrated human amnion and chorion membrane (dHACM) for chronic lower-extremity wounds in the diabetic population.
Methods: This randomized, prospective, controlled multicenter clinical trial was conducted throughout 14 U.S. wound care centers. Patients with Type 1 or Type 2 diabetes who presented with ulcer sizes > 1 cm2 and < 25 cm2 and duration of at least four weeks were included. All patients then entered into a two-week run-in period, during which time wounds were routinely debrided and treated with standard of care (SOC) wound care. Patients whose wounds had reduced by 25 percent or less (n=110) were then divided into two groups. One group was randomly assigned to receive weekly dHACM applications (n=54) with SOC, and the other group continued with SOC wound care alone (n=56), for a total of 12 weeks.
Results: At the end of this 12-week study, 70 percent (38/54) of dHACM-treated ulcers had completely healed, and 50 percent (28/56) of ulcers in the no-dHACM group healed (P = 0.0338). Additionally, 36/38 (95 percent) dHACM-treated ulcerations and 24/28 (86 percent) wounds healed without dHACM remained closed at the 16-week follow-up mark. Of note, the median number of grafts applied per healed wound was five (range 1–12).
Conclusions: The authors of this level 1 evidence study further confirmed that dHACM is an effective treatment for diabetic lower-extremity wounds, demonstrating significantly higher rates of complete and continued wound healing when compared to SOC therapy alone. The fact that this study was conducted at multiple wound care centers speaks to the fact that the efficacy of these products is not clinician dependent and can be used in a diverse patient population. The value of amnion and chorion products is promising; however, studies further elucidating their mechanisms of action, standardizing SOC and providing larger sample sizes and longer follow-ups would all provide added insight.