This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of intramuscular administration of human placenta-derived cells (PDA-002) in subjects with diabetic foot ulcers (DFU), including subjects with and without peripheral arterial disease (PAD). Subjects were randomized to receive one of three dose levels of PDA-002 or placebo. Randomization was stratified by PAD status. The study evaluated wound healing and safety outcomes over the follow-up period.
This Phase 2 study was designed to evaluate the efficacy and safety of PDA-002, a human placenta-derived cell therapy, administered via intramuscular injection in subjects with diabetic foot ulcers (DFU). The study included subjects with and without peripheral arterial disease (PAD), reflecting a broader DFU population. Subjects were randomized in a parallel-group design to receive PDA-002 at one of three dose levels (3 × 10\^6, 10 × 10\^6, or 30 × 10\^6 cells) or matching placebo, administered on Study Days 1 and 8. Randomization was stratified by PAD status. The primary objective was to assess efficacy in terms of wound healing outcomes, with secondary objectives evaluating vascular parameters such as ankle-brachial index (ABI), toe-brachial index (TBI), and transcutaneous oxygen pressure (TcPO2), as well as overall safety. The study was terminated early due to a business decision; however, subjects were followed according to protocol-defined follow-up schedules.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
159
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Percentage of Subjects With Complete Wound Closure of the Index Ulcer Within 3 Months
Complete wound closure is defined as closure of the index ulcer within 3 months after dosing and retaining wound closure for the subsequent 4 weeks.
Time frame: Within 3 months after dosing, with confirmation over the subsequent 4 weeks
Percentage of Subjects With Complete Wound Closure of the Index Ulcer Within 3 Months by PAD Status
Results are presented by baseline peripheral arterial disease (PAD) status (subjects with PAD and subjects without PAD). Complete wound closure is defined as closure of the index ulcer and retaining wound closure for the subsequent 4 weeks.
Time frame: Within 3 months after dosing, with confirmation over the subsequent 4 weeks
Percentage of Subjects With Improvement in Rutherford Classification at Month 3 in Subjects With PAD
Responders are defined as subjects who improved by at least 1 numeric Rutherford category from baseline. Results are reported for subjects with peripheral arterial disease (PAD).
Time frame: Month 3
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