Trials / Terminated
TerminatedNCT04927702
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Acera Surgical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care. In participants with venous leg ulcers (VLUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with living cellular skin substitute (Apligraf®)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Synthetic Hybrid-Scale Fiber Matrix | A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin. |
| DEVICE | Standard of Care | To ensure off-loading, each patient will be fitted with an off-loading device based on the investigator's decision, e.g. a boot for forefoot and a heel protector for hindfoot. Patients is instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean. If the wound is dry, a hydrogel category dressing type should be used. If the wound has exudate, an alginate or foam dressing is recommended. |
| DEVICE | Living Cellular Skin Substitute | An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds. |
Timeline
- Start date
- 2021-07-19
- Primary completion
- 2024-07-15
- Completion
- 2024-08-01
- First posted
- 2021-06-16
- Last updated
- 2026-02-27
- Results posted
- 2026-02-27
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04927702. Inclusion in this directory is not an endorsement.