Safety and Efficacy of ActiGraft Pro Compared to Standard of Care in DFUs (NCT04185558) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of ActiGraft Pro Compared to Standard of Care in DFUs
United States119 participantsStarted 2019-12-20
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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Inclusion Criteria:
* Subject is ≥19 years of age and has type 1 or 2 diabetes
* Chronic neuropathic DFU, located distal to the malleolus (excluding ulcers between the toes but including those of the heel) and depth ≤ 5 mm with no exposed capsule, tendon or bone and no tunneling, undermining or sinus tracts (Minor tunneling and undermining will be included).
* Ulcer size between 1 cm2 and 28 cm2 (post-debridement).
* For subjects with potentially multiple eligible DFUs, the largest non-healing wound will be selected.
* Ulcer duration of ≥ 30 days. Time 0 for ulcer duration of ≥ 30 days is defined as the first day of screening (i.e., day -14). Subjects will need to meet all inclusion criteria, including lack of ulcer healing until randomization day.
* Study ulcer separated from other ulcers by at least 1 cm.
* Ulcer or affected limb free of clinical signs of infection.
* Post-debridement, ulcer free of necrotic tissue.
* Adequate circulation to the affected extremity as demonstrated by at least one of the following: (1) Transcutaneous oxygen test (TcPO2) ≥ 30 mm Hg,; (2) Ankle Brachial Index (ABI) between 0.7 and 1.2; (3)Triphasic or biphasic Doppler arterial waveforms at the ankle of affected leg; (4) Toe Brachial Index \> 0.6
* HbA1c ≤ 12.0%
* Demonstrated adequate offloading regimen.
* Subject must be willing to comply with the protocol including having blood drawn to create the ActiGraft.
* Female subjects who are capable of conceiving and all males capable of inseminatio…