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

NCT01858545 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-04-15

Study results available
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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.

Conditions

  • Foot Ulcer, Diabetic

Interventions

DEVICE

MatriStem

MatriStem MicroMatrix and MatriStem Wound Matrix

DEVICE

Cellular Dermal Replacement Tissue

Cellular Dermal Replacement Tissue

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Thomas Gilbert, PhD · Integra LifeSciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01858545 on ClinicalTrials.gov