Snyder RJ, Kasper MA, Patel K, Carter MJ, Kushnir I, Kushnir A, Serena TE, et al.
Wounds : a compendium of clinical research and practice. Date of publication 2018 Jul 1;volume 30(7):84-89.
1. Wounds. 2018 Jul;30(7):84-89. Epub 2018 Apr 20.
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.
Snyder RJ, Kasper MA, Patel K, Carter MJ, Kushnir I, Kushnir A, Serena TE.
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.
PMID: 29718812 [Indexed for MEDLINE]
