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A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers

Foot Ulcer, Diabetic Clinical Trial

Official title:
An Evaluation of Tissue Engineering Approaches for Treatment of Neuropathic Diabetic Foot Ulcers Resistant to Standard of Care: A Prospective, Randomized Controlled Trial

Clinical Trial Summary

The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.

Clinical Trial Description

Due to their characteristically poor healing capacity, diabetic foot ulcers (DFUs) are challenging for clinicians to treat. This prospective, multi-center clinical study will examine outcomes following treatment of DFUs, with one of two FDA cleared tissue-engineered devices, MatriStem® or cellular dermal replacement tissue, on DFUs that have demonstrated an inadequate response to initial standard of care therapy. The incidence of ulcer closure, rate of wound closure, and quality of life will be evaluated over a eight week period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01858545
Study type Interventional
Source Integra LifeSciences Corporation
Contact
Status Terminated
Phase N/A
Start date May 2013
Completion date December 2015
View Details
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