Open-Label Extension Phase Of The Chronic Diabetic Foot Ulcer Multicenter, Controlled, Randomized Clinical Trial Confirms Benefits Of Viable Cryopreserved Placental Membrane For Wound Closure And Reduction Of Adverse Events

Study Objective: In a multicenter, blinded, randomized, controlled clinical trial (RCT), viable cryopreserved placental membrane (vCPM)* applications to chronic DFUs resulted in higher proportion of wound closure (62% vs. 21%), significantly fewer wound-related infections (18% vs. 36.2%) and lower cost of care compared to standard wound care (SWC). Twenty-six patients from the SWC arm whose wounds had not closed after 12 weeks of treatment in the blinded phase were enrolled in an open-label extension phase of the trial and received vCPM applications. Here we report vCPM outcomes in the single-arm open-label extension phase of the trial.

Study Methods: Patients received weekly application of vCPM for up to 12 weeks in conjunction with SWC. Wound assessments were performed weekly at each visit. The primary endpoint of the extension phase was complete wound closure. Other endpoints included the time to wound closure and number of vCPM applications needed for closure. Safety assessments included the number, type, and severity of adverse events (AEs). Descriptive statistics for continuous variables included the mean, standard deviation, median and subject counts; categorical variables were summarized in terms of frequencies and percentages. Statistical comparisons between treatment groups were performed using Fisher's exact one-sided test and Wilcoxon test.

Study Findings: 65.4% of patients closed their wounds in a median of 34 days and 3 visits. There were fewer adverse events (AEs) (24 vCPM vs 52 SWC) and wound-related infections (5 vCPM vs 12 SWC) during vCPM applications compared to the number of AEs for the same patients during the prior SWC treatment in the blinded phase of the trial.

Conclusions: These results corroborate the benefits of vCPM over SWC for chronic DFUs previously reported for the blinded randomized phase of the trial which directly relate to lower healthcare costs.