Efficacy and Safety of Intramuscular PDA-002 in Subjects With Diabetic Foot Ulcer With and Without PAD.

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.