Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT05687656
Brief 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.
Study:
NCT05687656
Study Brief:
Protocol Section:
NCT05687656