Miro3D Wound Matrix for Foot Ulcer

(FOCUS 3D Trial)

This trial aims to determine if adding the Miro3D Wound Matrix to standard care enhances healing of chronic diabetic foot ulcers compared to standard care alone. Diabetic foot ulcers are persistent wounds that often resist healing, even with regular treatment, which includes cleaning and reducing pressure on the wound. The Miro3D Wound Matrix, made from pig tissue, may improve healing. Individuals with a diabetic foot ulcer lasting more than 4 weeks but less than a year, who have not seen significant improvement with regular treatment, might be suitable for this trial. Participants will be randomly assigned to receive either the new treatment alongside standard care or just the standard care, with follow-ups over 12 weeks. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for difficult-to-heal wounds.

Research has shown that the Miro3D Wound Matrix is generally safe. In a study on diabetic foot ulcers, participants experienced no harmful effects from the treatment. Researchers monitored safety by observing any unwanted side effects during the trial. So far, no major safety issues have emerged, suggesting that patients tolerate the Miro3D Wound Matrix well.¹²³⁴⁵

Unlike the standard of care for foot ulcers, which typically involves procedures like sharp debridement, offloading, and moisture-retentive dressings, the Miro3D Wound Matrix introduces a unique approach. This treatment uses a 3D wound matrix designed to enhance healing by providing a scaffold that supports cell growth and tissue regeneration. Researchers are excited about Miro3D because it potentially accelerates healing and improves outcomes by offering a more structured environment for wound repair, which current treatments do not specifically address.

Studies have shown that the Miro3D Wound Matrix can help heal diabetic foot ulcers more effectively. In one study with 73 patients, those treated with a similar matrix had a higher healing rate of 49% compared to another treatment. Another study found that 62% of wounds were halfway healed by four weeks when using a three-dimensional acellular matrix. This matrix provides a support structure for new tissue growth, aiding faster and more complete wound healing. In this trial, participants will receive either the Miro3D Wound Matrix in addition to standard care or standard care alone. Initial findings suggest that adding Miro3D to standard care could significantly improve wound healing in patients with chronic diabetic foot ulcers.¹³⁴⁵⁶