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

Determine the effectiveness of hypothermically stored amniotic membrane (HSAM) versus standard of care (SOC) in diabetic foot ulcers (DFUs). A randomized controlled trial was conducted on 76 DFUs analyzed digitally. Cox wound closure for HSAM (38 wounds) was significantly greater (p = 0.

Human placental membrane as a wound cover for chronic diabetic foot ulcers: a prospective, postmarket, CLOSURE study.

Objective: To evaluate the safety and efficacy of a chorioamniotic allograft, used as a wound cover for chronic foot ulcers, in patients with diabetes.

Methods: A multicentre, prospective, postmarket study where eligible patients received up to 11 weekly wound cover applications. Computerised planimetry was used to calculate the diabetic foot ulcer (DFU) area each week.

Safety and Efficacy of an Autologous Blood Clot Product in the Management of Texas 1A or 2A Neuropathic Diabetic Foot Ulcers: A Prospective, Multicenter, Open Label Pilot Study.

Objective: This pilot study evaluates safety in terms of the occurrence of adverse events (AEs) as well as the efficacy in terms of complete wound healing rates of a blood clot product when applied to chronic neuropathic diabetic foot ulcers (DFUs).

Materials And Methods: Participants were chosen from patients with DFUs visiting the wound care clinic. Up to 10 mL of blood drawn from each participant was injected into the product's clotting tray.