A Longitudinal Study to Evaluate an Extracellular Matrix (MatriStem®) for the Treatment of Diabetic Foot Ulcers — M-S-DFU-RCT  

Neuropathic Diabetic Foot Ulcer Clinical Trial

Official title: A Prospective, Randomized, Controlled, Longitudinal Study Using Repeated Measures Design to Evaluate a Porcine Urinary Bladder-Derived Extracellular Matrix (MatriStem®) in the Management of Diabetic Foot Ulcers

Status Completed

Clinical Trial Summary

This ia a prospective controlled longitudinal study to evaluate the effects of MatriStem® plus standard local wound care versus standard local wound care alone in the treatment of diabetic foot ulcers (DFUs), as assessed by incidence of complete wound healing by 16 weeks and ulcer recurrence with a 2 year follow-up.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Neuropathic Diabetic Foot Ulcer
• Ulcer

• NCT number: NCT02750280
• Study type: Interventional
• Source: Calvary Hospital, Bronx, NY
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Completion date: December 2015