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. Within 12 minutes, the blood clot product was formed, applied to the single DFU of each participant, and covered with primary and secondary dressings. Patients received up to 12 blood clot product applications every 5 to 9 days for up to 12 weeks.

RESULTS: Twenty patients were enrolled; 20 were analyzed in the intent-to-treat (ITT) population and 18 were in the per-protocol (PP) population. Thirty-two AEs occurred (only 2 were possibly device related). The mean AE rate for both the ITT and PP populations was 1.6. The proportion of wounds healed in the ITT and PP populations was 13 out of 20 (65%) and 13 out of 18 (72.2%), respectively. Percentage area reduction (PAR) for the ITT population at 4 and 12 weeks was 61.6% and 67.1%, respectively; the PARs for the PP population were 60.3% and 76.2% at 4 and 12 weeks, respectively. Mean times to wound healing were 59 days and 56 days in the ITT and PP populations, respectively.

CONCLUSIONS: This study demonstrates that the blood clot product is safe and efficacious for treating DFUs.