NCT04185558

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

Multi-Center, Prospective, Randomized, Controlled, Trial, Comparing the Safety and Efficacy of ActiGraft Pro™ to Standard of Care in Patients With Chronic Neuropathic Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: RedDress Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot
• Chronic Ulcer

Interventions

Type	Name	Description
DEVICE	ActiGraft	Whole Blood Clot (WBC) gel
DEVICE	Standard of Care	Alginate dressing, a non-adherent foam dressing, and an outer gauze wrap

Timeline

• Start date: 2019-12-20
• Primary completion: 2024-03-31
• Completion: 2024-04-01
• First posted: 2019-12-04
• Last updated: 2024-05-14

Locations

16 sites across 3 countries: United States, South Africa, Turkey (Türkiye)

Regulatory

• FDA-regulated device study