Dehydrated placental allograft (DPA) for the management of diabetic foot ulcers – a randomized controlled trial

Objectives: Diabetic foot ulcers (DFUs) continue to challenge wound care practitioners. They are prone to infection and increase the risk of lower extremity amputation. The aim of this study was to evaluate the effectiveness of dehydrated placental allograft (DPA)(a) and standard of care (SOC) in DFUs.

Methods: A randomized controlled trial (RCT) was conducted in which 60 subjects were allocated to DPA in addition to standard of care (SOC) (n=31), or SOC alone (n=29). Photographs and ulcer measurements were taken, and wound closure efficacy endpoints were evaluated. The primary endpoint was frequency of wound closure evaluated by a Cox proportional hazards regression analysis (Cox) that adjusted for multiple covariates including wound duration and size at baseline. Arithmetic mean times to wound closure were computed and wound measurement reductions from baseline were assessed as secondary endpoints.

Results: The treatment groups had no significant differences in baseline demographics or ulcer characteristics. A forward selection Cox regression analysis showed that the estimated frequency of wound closure for DPA was superior to SOC at week 12 (55% vs. 41%), 16 (61% vs. 41%), 20 (68% vs. 44%), and 24 (77% vs. 52%), respectively. The computed hazard ratio [HR=1.55 (1.21, 1.89)] indicated a 55% greater probability of wound closure in favor of the DPA group. Mean time to wound closure for DPA-treated versus SOC-treated ulcers was 50 days compared to 52 days respectively. DPA-treated DFUs showed clinically meaningful reductions in wound measurements from baseline with a high incidence of >60% reduction in area (90%) and >75% reduction in volume (83%).

Conclusions: DPA holds promise for improving wound closure and providing cost-effective care in non-healing DFUs. Evidence showed that use of DPA reduced wound areas and volumes as well as increasing the frequency of wound closure.
 (a)NuShield®, Organogenesis Inc., Canton MA

Trademarked Items (if applicable): (a) NuShield®, Organogenesis Inc., Canton MA

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