Kerecis Real-World Fish Skin Graft Registry
Part of paid clinical trials in Sarasota, Florida.
- Sponsor
- Kerecis Ltd.
- Study ID
- NCT06384183
- Status
- Enrolling By Invitation
Conditions
- Diabetic Foot Ulcer
- Pressure Ulcer
- Soft Tissue Reinforcement
- Surgical Wound
- Venous Leg Ulcer
- Wounds
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Kerecis Fish Skin Graft — DEVICEPatients already treated with a Kerecis device
Study Details
Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices
Key Dates
- Start date
- Aug 7, 2024
- Status verified
- Aug 2024
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 600 participants (estimated)
Arms
- Arm: Observational GroupThis observational (i.e., non-interventional), post-market, real-world, Registry was designed to collect, analyze, and identify relevant safety and performance outcomes for "all comers" using Kerecis devices in routine medical practice within a wide variety of United States (US) medical practice settings.
Primary Outcome Measure
Fish Skin Graft Device Related failure [ Time Frame: 12 months ]
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| MCR Health | Sarasota | Florida | 34237 | - |
| University Park | Sarasota | Florida | 34243 | - |
| Cone Health Ortho Care Greensboro | Greensboro | North Carolina | 27401 | - |
| Feet First Institute of Beavercreek | Beavercreek | Ohio | 45432 | - |
| ABC Podiatry | Columbus | Ohio | 43213 | - |
| South Texas Skin Cancer Center | San Antonio | Texas | 78215 | - |
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