Study of Miro3D Wound Matrix Plus Standard Care Versus Standard Care Alone for Healing Chronic Diabetic Foot Ulcers

What this Trial Is About

Researchers are evaluating whether adding the Miro3D Wound Matrix to standard care improves healing in adults with chronic diabetic foot ulcers. Diabetic foot ulcers are a serious complication of diabetes that may not heal well with usual treatment. This study compares healing outcomes between patients receiving Miro3D plus standard care and those receiving standard care alone, aiming to support wound healing and reduce complications such as infection and amputation. The trial enrolls about 180 adults with Wagner Grade 1 or 2 diabetic foot ulcers lasting between 4 weeks and 12 months. After a two-week screening period, participants are randomly assigned to one of two groups one receiving Miro3D Wound Matrix applied topically to the ulcer along with standard care, and the other receiving standard care alone. Standard care includes sharp debridement, offloading with a device, and moisture-retentive dressings. Participants are followed weekly for up to 12 weeks. During each weekly visit, researchers assess wound size, take photographs, check for infection, and measure pain using a numeric scale. Safety is monitored throughout by tracking adverse events. Some sites may also perform special imaging tests to explore tissue oxygenation and wound characteristics. The main outcomes measured are the rate of complete wound closure at 12 weeks and the percentage reduction in ulcer size. Secondary outcomes include pain changes and adverse events, with follow-up visits continuing as scheduled for up to 12 weeks.

Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers