Analysis of Three Prospective Open-Label Clinical Trials with Autologous Blood Clot in Chronic Wounds

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

Tools and Method: All studies were approved by IRB. All studies were monitored by third-party CRO. Studies were conducted in five centers: three wound care clinics and two specialized nursing facilities (four USA, one Israel). Wounds were treated weekly with RD1 for up to 12 weeks.

Results: Total of 42 subjects enrolled, number of subjects and their wound were: 20 DFUs, nine PUs, seven VLUs, six skin tears (ST). Forty-two subjects were analyzed for the ITT (intent-to-treat) population, including all patients who did not complete more than one treatment or withdrew. The PP (per protocol) population that completed at least four weeks of treatment included 38 subjects. The proportion of wounds completely healed in the ITT populations was 27/42 (64%), and 27/38 (71.1%) for the PP population. Percentage area reduction (PAR) for the ITT population at four and 12 weeks was 62% and 79.%, respectively.

Conclusion: The 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.