Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical … (NCT06319287) | Clinical Trial Compass
CompletedPhase 2
Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)
United States59 participantsStarted 2024-02-27
Plain-language summary
This is a Phase 2a Multi-Center, Prospective, Randomized, Controlled Study aimed to evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects with Diabetic Foot Ulcers (DFU)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males and females ≥ 18 years of age
✓. Properly obtained written informed consent
✓. Documented history of Type I or Type II Diabetes Mellitus, requiring oral and/or insulin replacement therapy
✓. The index ulcer is classified as Wagner grade 1 ulcer and remains Wagner 1 Grade between Screening and Randomization/Baseline visit (Visit 1 through Visit 3)
✓. These ulcers are superficial, full-thickness ulcers limited to the dermis, not extending to the subcutaneous tissue
✓. Area of index ulcer must be between 1 cm2 to 15 cm2 post debridement at screening and baseline
✓. The index ulcer must be located anatomically on the foot with ≥ 50% of the wound area below the medial or lateral malleolus
✓. Presence of a persistent nonhealing DFU for at least 4 weeks from Randomization and not more than 1 year that has failed to respond to SOC at any point during this timeframe
Exclusion criteria
✕. Actively undergoing chemotherapy treatment (localized radiation treatment is allowed if it is not on the DFU wound site and in remission based on scans, bloodwork or some other kind of test, such as a breast biopsy or a bone marrow biopsy)
✕. Ulceration with exposed tendon, capsule, or bone
✕. Suspicion of bone or joint infection by clinical or other criteria as per STONEES criteria below:
✕. Unable or unwilling to utilize the protocol defined offloading device
✕. Subjects who have undergone endovascular or open revascularization of the index limb within the last 30 days from Screening.
✕. Index ulcer has decreased in area by ≥ 30% between Screening (Visit 1) and Baseline visits
✕. Any subject that is currently on/or requires oral, systemic or topical antibiotics, or is anticipated to require their use during the course of the study
✕. Any subject that has vascular compromise requiring surgical intervention or has undergone vascular reconstruction or angioplasty less than 1 month prior to randomization. Any planned surgical procedures during the study participation