Snyder RJ, Shimozaki K, Tallis A, Kerzner M, Reyzelman A, Lintzeris D, Bell D, Rutan RL, Rosenblum B, et al.
Wounds : a compendium of clinical research and practice. Date of publication 2016 Mar 1;volume 28(3):70-7.
1. Wounds. 2016 Mar;28(3):70-7.
A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of
Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the
Closure of Chronic Diabetic Foot Ulcer.
Snyder RJ(1), Shimozaki K(2), Tallis A(3), Kerzner M(4), Reyzelman A(5),
Lintzeris D(6), Bell D(7), Rutan RL(8), Rosenblum B(9).
Author information:
(1)Barry University Clinical Research, North Miami Beach, FL.
(2)Pacific Wound Center, Stockton, CA;
(3)Associated Foot and Ankle Specialists, Phoenix, AZ.
(4)Duke University Medical Center, Durham, NC.
(5)Center for Clinical Research, San Francisco, CA.
(6)Wayne Memorial Wound Healing and Hyperbaric Center, Goldsboro, NC.
(7)First Coast Cardiovascular Institute, Jacksonville, FL.
(8)Derma Sciences Inc, Princeton, NJ.
(9)Beth Israel Deaconess Hospital, Plymouth, MA.
Delayed closure of foot ulcers is a primary factor leading to lower extremity
amputation in patients with diabetes, creating great demand for products or
therapies to accelerate the rate of wound closure in this population. This study
(ClinicalTrials.gov Identifier: NCT02209051) was designed to evaluate dehydrated
amniotic membrane allograft (DAMA) (AMNIOEXCEL, Derma Sciences Inc, Princeton,
NJ) plus standard of care (SOC) compared to SOC alone for the closure of chronic
diabetic foot ulcers (DFUs).MATERIALS AND METHODS: This prospective, open-label,
randomized, parallel group trial was implemented at 8 clinical sites in the
United States. Eligibility criteria included adults with type 1 or type 2
diabetes mellitus who have 1 or more ulcers with a Wagner classification of grade
1 or superficial 2 measuring between 1 cm2 and 25 cm2 in area, presenting for
more than 1 month with no signs of infection/osteomyelitis; ABI > 0.7; HbA1c Less
than 12%; and serum creatinine less than 3.0 mg/dL. Eligible subjects were
randomized (1:1) to receive either SOC alone (n = 14) or DAMA+SOC (n = 15) until
wound closure or 6 weeks, whichever occurred first. The endpoint was the
proportion of subjects with complete wound closure (defined as complete
reepithelialization without drainage or need for dressings).
RESULTS: Thirty-five percent of subjects in the DAMA+SOC cohort achieved complete
wound closure at or before week 6, compared with 0% of the SOC alone cohort
(intent-to-treat population, P = 0.017). There was a more robust response noted
in the per protocol population, with 45.5% of subjects in the DAMA+SOC cohort
achieving complete wound closure, while 0% of SOC-alone subjects achieved
complete closure (P = 0.0083). No treatment-related adverse events were reported.
CONCLUSION: The results suggest DAMA is safe and effective in the management of
DFUs, but additional research is needed.
PMID: 26978860 [Indexed for MEDLINE]
