NCT05687656

Sterilised, Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers

A Prospective, Multi-center Observational Study to Investigate the Safety and Effectiveness of Sterilized, Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: ConvaTec Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Prospective, Non-Randomized, Multi-Center Observational Study To determine the safety and effectiveness of InnovaMatrix AC porcine placental ECM therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs) Eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading

Detailed description

This is a prospective, multi-center observational study . The trial will include 30 completed subjects at three (3) experienced clinical centers in the United States. The estimated enrollment period is 13 weeks. After completing a screening , the subjects will be enrolled and receive treatment followed for at least 12 weeks. It is expected that the majority of the subjects will be recruited from patients being seen in the Investigators' practices. No minors will be included in the study and it is anticipated that there will be a roughly equal representation of male and female subjects. Further, no subjects will be excluded because of race or ethnicity and all efforts will be made to adequately represent the study population in the area in which they are chosen. All subjects will be used for the analysis of efficacy and safety data.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	InnovaMatrix AC porcine placental ECM therapy	All eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care moist wound therapy and offloading

Timeline

• Start date: 2022-10-06
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-01-18
• Last updated: 2025-05-31

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study