Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT03312595
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
Study:
NCT03312595
Study Brief:
Protocol Section:
NCT03312595