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Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)

Diabetic Foot Ulcer Clinical Trial

Official title:
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) A Case Series of Initial Effectiveness and Safety Measures

Clinical Trial 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).

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03312595
Study type Interventional
Source Acera Surgical, Inc.
Contact
Status Completed
Phase N/A
Start date September 14, 2017
Completion date July 30, 2018
View Details
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