Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-04-25 @ 1:07 AM
Study NCT ID:
NCT03312595
Status:
COMPLETED
Last Update Posted:
2025-09-16
First Post:
2017-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)
Sponsor:
Acera Surgical, Inc.
Organization:
Study Overview
Official Title:
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) A Case Series of Initial Effectiveness and Safety Measures
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™). Results of this study may be used to make decisions on whether to conduct additional studies on this particular wound matrix product. RestrataTM has been cleared by the Food and Drug Administration for use in certain types of ulcer treatments, including the type that will be part of this study (diabetic foot ulcers).
Detailed Description:
Control Group: None (Utilize historical / published data on outcomes using standard of care)
Test Group: Treatment of DFUs with RestrataTM Wound Matrix
Study Type: Interventional
Study Design: Allocation: Non-randomized Endpoint Classification: Efficacy Intervention Model: Direct assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Test Group: Treatment of DFUs with RestrataTM Wound Matrix
Study Type: Interventional
Study Design: Allocation: Non-randomized Endpoint Classification: Efficacy Intervention Model: Direct assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: