A randomized controlled clinical trial of a hypothermically stored amniotic membrane for use in diabetic foot ulcers

Abstract

Aim: Determine the effectiveness of hypothermically stored amniotic membrane (HSAM) versus standard of care (SOC) in diabetic foot ulcers (DFUs). Methods: A randomized controlled trial was conducted on 76 DFUs analyzed digitally. Results: Cox wound closure for HSAM (38 wounds) was significantly greater (p = 0.04) at weeks 12 (60 vs 38%), and 16 (63 vs 38%). The probability of wound closure increased by 75% (Hazard Ratio = 1.75; 95% CI: 1.16–2.70). HSAM showed >60% reductions in area (82 vs 58%; p = 0.02) and depth (65 vs 39%; p = 0.04) versus SOC. Conclusion: HSAM increased frequency and probability of wound closure in DFUs versus SOC.

Effectiveness and safety of human amnion/chorion membrane therapy for diabetic foot ulcers: An updated meta‐analysis of randomized clinical trials

“…Then, detailed evaluation of full texts resulted in the removal of 34 articles for the following reasons: were reviews (n = 23); were not RCTs (n = 7); was a duplicate study (n = 1) 26 ; ST was not used as control treatment (n = 3) 27‐29 . Finally, nine studies were eligible for this meta‐analysis 18,30‐37 . The study 34 published by Zelen et al in 2016 was an extension of their previous study 31 published in 2015.…”

“…Only four studies 31,34,35,37 reported allocation concealment. Participants and personnel in most studies 18,30,31,33,34,36,37 were aware of group assignment while outcome assessors were blinded to group assignment in six studies 30,31,34‐37 . For attrition bias and reporting bias, all studies were considered to have a low risk.…”

“…For attrition bias and reporting bias, all studies were considered to have a low risk. It should be noted that several studies 30,31,33,36,37 were sponsored by the product manufacturers and that the existence of finical interests was not clear in the remaining studies 18,32,33,35 …”

“…Almost all studies defined ulcer healing as the complete reepithelialization of the wound without drainage or need for dressing, excepting for the study of Serena et al, 36 in which ulcer closure was defined as a wound achieving an area between 0 and 0.1 cm 2 .…”

“…There were six studies 18,30,34‐37 reporting the incidence of healed ulcers in 12 weeks; 227 and 228 patients were randomly assigned to HACM and ST group, respectively. The pooled results showed that compared with ST group, HACM group had a higher ulcer healing rate at 12 weeks (RR = 2.09, 95% CI: 1.53‐2.85, P < 0.00001; I 2 = 57%; Figure 3C).…”