Safety and Efficacy of ActiGraft Pro Compared to Standard of Care in DFUs

Study Summary

* The study is a multi-center, prospective, randomized, controlled, single blinded clinical study consisting of 150 subjects from up to 20 centers. * The subjects are randomized to receive 1 of 2 treatments, either with ActiGraft and standard of care (SOC) or with SOC alone. * The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of the ActiGraft + SOC or SOC until for up to 12 weeks or until the study ulcer has completely healed (i.e., 100% closure as assessed by the Investigator and blinded assessor and confirmed 2 weeks later at the healing confirmation visit (HCV). One additional visit per week is optional for both arms, for the purpose of changing only (1) the secondary dressing in the ActiGraft arm or (2) change the standard of care dressing in the control arm. * Immediately after the study ulcer is confirmed as completely healed, subjects will enter the 12-week Follow-up Phase. During the Follow-Up phase, subjects will be evaluated twice during the first month and then monthly for two additional visits every 4 weeks until the completion of the 12-week Follow-up Phase.

Primary Outcome

Incidence of complete wound closure by 12 weeks using chi square (two-sided; alpha set at .05 level of significance), or Fischer exact test if one group has ≤ 5 completely closed wounds. Analysis will be adjusted using generalized linear modeling (logit function).

Conditions Studied

Interventions

• DEVICE ActiGraft
• DEVICE Standard of Care

Study Locations (16)