Meta Analysis of 3 Prospective, Open-Label, Studies with Autologous Blood Clot in Chronic Wounds

Background: The RD1 product (RedDress Ltd.) which was cleared by FDA in July 2018, for creating autologous blood clots for management of cutaneous wounds, was the subject of 3 prospective studies. Data from the 3 studies was analyzed and results are reported.

Tools and method: All 3 studies were approved by IRB. All studies were monitored by 3rd party CRO. Studies were conducted in 5 centers: 2 skilled nursing facilities and 3 wound care clinics (4 USA, 1 Israel). Wounds were treated weekly for up to 12 weeks with the RD1. Total of 39 subjects enrolled, number of subjects and their wound was: 20 DFUs, 8 PUs, 6 VLUs, 5 Skin Tears (ST). 39 subjects were analyzed for the ITT (intent-to-treat) population, including all patients that did not complete more than 1 treatment or withdrawn. The PP (per protocol) population that completed at least 4 weeks of treatment included 35 subjects. 

Results: The proportion of wounds completely healed in the ITT populations was 25/39 (64%) and 25/35 (71.5%) for the PP population. Percentage area reduction (PAR) for the ITT population at 4 and 12 weeks was 64% and 69.2%, respectively.

Conclusion: The meta analysis is consistent with the efficacy results of the RD1 in literature, demonstrating the high effectiveness of healing chronic ulcers with the use of Autologous blood clot.