Prospective Trial Compares Intact Full-thickness Placental Membrane with Standard Moist Wound Therapy in Diabetic Foot Ulcers

In a recently presented poster at SAWC Spring in National Harbor, Maryland, a group of investigators reported the preliminary results of their prospective multicenter randomized controlled open-label trial in which the clinical effectiveness of a placental membrane was evaluated in patients with diabetic foot ulcers. The researchers of this study included Alexander M. Reyzelman, DPM; Bradley Wetzell, PhD; Julie B. McLean, PhD; Barry Saxton, RN, PA-C; Andrew Farmer, BS; and Alyce Jones, PhD.

Chronic wounds pose a significant economic burden on the US health care system as well as the patients and their caregivers and loved ones. Overall health care spending in developed countries is estimated at 1% to 4% in developed countries.¹ Various management and treatment options exist for chronic wounds, including diabetic foot ulcers. These options could include cellular or tissue-based products, advanced wound dressings, and topical agents

In their study, Reyzelman and colleagues sought to assess the clinical effectiveness of a minimally manipulated, intact full-thickness placental membrane that uses a placental processing in which the amnion and chorion layers are not separated. Separating the layers can adversely affect native growth factors, causing the allograft to be difficult to work with due to its thinness.² With the allograft studied in Reyzelman et al’s research, the layers are not separated, thus minimizing the potential for a patient to have an inflammatory reaction, improving the handling of the graft, improving the barrier to bacterial ingress, and providing a porous scaffold for host-cell migration, attachment, and neovascularization.

After obtaining IRB approval, the investigators considered up to 120 patients, who would meet all inclusion criteria and provide informed consent, to be randomized at a 1:1 ratio and receive either the studied allograft or conventional care of moist wound therapy. Treatment was applied to its respective treatment arm after baseline evaluations pre- and post-debridement of the wound bed. Wounds were dressed on a weekly basis with subsequent weekly reevaluation visits until 100% reepithelialization was met or up to 12 weeks, dependent on which came first. Patients offloaded as appropriate. The primary endpoint of the analysis was the proportion of wounds closed at 12 weeks in each group. Secondary endpoints consisted of mean number of allograft applications and mean percent wound area reduction from weeks 1 to 12.

The authors had a total of 25 patients (allograft, 14 patients; conventional care, 11 patients) complete the treatment phase. The allograft group had a significantly higher proportion of wounds healed (64%) versus the conventional care group (27%). They also found mean percent wound area reduction was also higher in the allograft group starting at week 3 and reaching significance at weeks 9, 10, and 11. The mean number of allograft applications was 8.4.

-Jaclyn Gaydos, Senior Managing Editor

Poster Reference: Reyzelman AM, Wetzell B, McLean JB, Saxton B, Farmer A, Jones A. A prospective multicenter randomized controlled open-label trial to assess the clinical effectiveness of a decellularized full-thickness placental membrane in patients with diabetic foot ulcers: preliminary results. Poster presented at: Symposium on Advanced Wound Care Spring; April 26-30, 2023; National Harbor, MD.

1. Armstrong DG, Boulton AJM, Bus SA. Diabetic foot ulcers and their recurrence. N Engl J Med. 2017;376(24):2367-2375. doi:10.1056/NEJMra1615439
2. Qin X, Chen S, Aschenbach L, Chen J, Inventors; LifeNet Health, assignee. WO/2017/112934. Decellularized placental membrane and methods of preparing and use thereof. 2017.