Trials / Active Not Recruiting
Active Not RecruitingNCT06400875
Observational Study to Investigate the Use of Sterilized Porcine Placental Tissue in the Treatment of Chronic VLU
A Prospective, Multi Center Observational Study to Investigate the Safety and Effectiveness of Sterilized, Porcine Placental Tissue in the Treatment of Chronic Venous Leg Ulcers
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 37 (actual)
- Sponsor
- ConvaTec Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study is a multi-center, prospective, clinical trial designed to evaluate the use of InnovaMatrix AC sterilized porcine placental ECM to treat chronic VLUs . The trial will include 30 completed subjects at multiple, experienced clinical centers in the United States.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | InnovaMatrix® AC Sterilized, Porcine Placental Extracellular Matrix (ECM) | weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and compression therapy |
Timeline
- Start date
- 2023-07-10
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
- First posted
- 2024-05-06
- Last updated
- 2025-05-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06400875. Inclusion in this directory is not an endorsement.