Trials / Completed
CompletedNCT04918784
Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcer
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Acera Surgical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the following prospective, randomized, controlled clinical trial is to compare synthetic hybrid-scale fiber matrix (Restrata®, Acera Surgical, Inc.) with standard of care in treating diabetic foot ulcers in human subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Restrata® | Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix. |
| DEVICE | Wound Dressing | Alginate or Foam wound dressing is intended to manage wounds. |
Timeline
- Start date
- 2021-05-05
- Primary completion
- 2022-07-31
- Completion
- 2022-12-01
- First posted
- 2021-06-09
- Last updated
- 2023-09-28
- Results posted
- 2023-09-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04918784. Inclusion in this directory is not an endorsement.