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

2019-12-10 01:21:06 | BioPortfolio

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.

Study Design

Conditions

Diabetic Foot

Intervention

ActiGraft, Standard of Care

Location

Institute for Advanced Wound Care
Montgomery
Alabama
United States
36111

Status

Not yet recruiting

Source

RedDress Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-12-10T01:21:06-0500

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Medical and Biotech [MESH] Definitions

Common foot problems in persons with DIABETES MELLITUS, caused by any combination of factors such as DIABETIC NEUROPATHIES; PERIPHERAL VASCULAR DISEASES; and INFECTION. With the loss of sensation and poor circulation, injuries and infections often lead to severe foot ulceration, GANGRENE and AMPUTATION.

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Devices used to support or align the foot structure, or to prevent or correct foot deformities.

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