Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers (NCT03998436) | Clinical Trial Compass
CompletedPhase 3
Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers
India176 participantsStarted 2018-12-26
Plain-language summary
The purpose of the current Study is to determine the safety and effectiveness of Galnobax® plus Standard of Care versus only Standard of Care, in treating Diabetic Foot Ulcers (DFU). In addition, Study is designed to investigate the safety of Galnobax® vehicle for establishing non-deleterious effects of Vehicle on wound healing in the Subjects with DFU. The study is being conducted in 350 subjects being recruited in about 30 centers in India.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subjects, male or female, aged 18 to 75 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control
✓. Subject has glycosylated hemoglobin, HbA1C, ≤ 12%
✓. Subject with diagnosis of neuropathic foot ulcer by 10g monofilament test
✓. Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.3
✓. Presence of at least one DFU that meets all of the following criteria:
✓. A full-thickness ulcer of Grade A1 as per Texas classification system;
✓. Ulcer is located below or up to 5 cm above the malleoli (excluding ulcers between the toes);
✓. Ulcer size (area) is ≥ 2 cm2 and ≤ 15 cm2 (post-debridement);
Exclusion criteria
✕. Actively infected ulcers with or without purulent discharge, ulcers with exposed bone or associated with osteomyelitis
✕. Subjects with more than three ulcers below knee
✕. Subjects with Target Ulcer requiring off-loading that cannot be effectively off-loaded; or unable to tolerate the off-loading method
✕. Subject has ulcers caused by a disease other than diabetes, e.g., fungal ulcerations, malignant ulcerations, and ulcerations due to venous or arterial insufficiency, or due to hematological disorders, in the opinion of the Investigator
What they're measuring
1
Proportion of Subjects Achieving Target Ulcer Closure Within 12-week Treatment Phase, as Assessed by Blinded Investigator
Timeframe: Wound closure assessed up to week 12 and confirmed by 2 visits 2 weeks apart; only participants with wound closure at or before Week 12 and who maintained closure after 4-weeks of follow-up reported