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Tettelbach W, Cazzell S, Reyzelman AM, Sigal F, Caporusso JM, Agnew PS, et al.
International wound journal. Date of publication 2018 Aug 22;volume ():.
1. Int Wound J. 2018 Aug 22. doi: 10.1111/iwj.12976. [Epub ahead of print] A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers: A prospective, multicentre, randomised, controlled study of 110 patients from 14 wound clinics. Tettelbach W(1), Cazzell S(2), Reyzelman AM(3), Sigal F(4), Caporusso JM(5), Agnew PS(6). Author information: (1)Wound Care & Hyperbaric Medicine Clinical Services, Intermountain Healthcare, Salt Lake City, Utah. (2)Limb Preservation Platform, Inc., Fresno, California. (3)Center for Clinical Research, Inc., San Francisco, California. (4)Foot and Ankle Clinic, Los Angeles, California. (5)Futuro Clinical Trials, Texas. (6)Coastal Podiatry, Inc., Virginia Beach, Virginia. A randomised, controlled multicentre clinical trial was conducted at 14 wound care centres in the United States to confirm the efficacy of dehydrated human amnion/chorion membrane allograft (dHACM) for the treatment of chronic lower extremity ulcers in persons with diabetes. Patients with a lower extremity ulcer of at least 4 weeks duration were entered into a 2-week study run-in phase and treated with alginate wound dressings and appropriate offloading. Those with less than or equal to 25% wound closure after run-in were randomly assigned to receive weekly dHACM application in addition to offloading or standard of care with alginate wound dressings, for 12 weeks. A total of 110 patients were included in the intent-to-treat (ITT) analysis, with n = 54 in the dHACM group and n = 56 in the no-dHACM group. Of the participants, 98 completed the study per protocol, with 47 receiving dHACM and 51 not receiving dHACM. The primary study outcome was percentage of study ulcers completely healed in 12 weeks, with both ITT and per-protocol participants receiving weekly dHACM significantly more likely to completely heal than those not receiving dHACM (ITT-70% versus 50%, P = 0.0338, per-protocol-81% versus 55%, P = 0.0093). A Kaplan-Meier analysis was performed to compare the time-to-healing performance with/without dHACM, showing a significantly improved time to healing with the use of allograft, log-rank P < 0.0187. Cox regression analysis showed that dHACM-treated subjects were more than twice as likely to heal completely within 12 weeks than no-dHACM subjects (HR: 2.15, 95% confidence interval 1.30-3.57, P = 0.003). At the final follow up at 16 weeks, 95% of dHACM-healed ulcers and 86% of healed ulcers in the no-dHACM group remained closed. These results confirm that dHACM is an efficacious treatment for lower extremity ulcers in a heterogeneous patient population. © 2018 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd. DOI: 10.1111/iwj.12976 PMID: 30136445
Appears in following Topics:
Cellular and/or Tissue Based Products
Diabetic Foot Ulcer - Treatment