Evaluating Porcine Placental Matrix Plus Standard Wound Care Compared to Standard Care Alone for Diabetic Foot Ulcers

What this Trial Is About

Researchers are conducting a multi-center, randomized controlled clinical trial to compare the effectiveness of Porcine Placental Extracellular Matrix PPECM combined with standard wound care versus standard wound care alone in treating hard-to-heal diabetic foot ulcers. This study focuses on adults with diabetic ulcers that have shown delayed healing and aims to improve closure rates over a 12-week period. Participants are divided into two groups. One group receives standard wound care, which includes wound cleansing with sterile solutions, wound bed debridement as needed, appropriate primary and secondary dressings to maintain a moist environment, off-loading devices to reduce pressure on the wound, and systemic antibiotics when necessary. The other group receives the same standard care plus weekly applications of PPECM for up to 12 weeks, applied after cleansing and debridement but before the primary dressing. During the study, participants will undergo regular wound assessments to monitor healing progress, including measurement of wound closure at 12 weeks as the primary outcome. They will be followed with weekly visits for wound care and PPECM application if assigned to that group. Researchers will also evaluate safety and adherence throughout the study. The total participation time spans at least 12 weeks, with ongoing monitoring to determine the effectiveness of the combined treatment in promoting diabetic foot ulcer healing.

IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers