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A Longitudinal Study to Evaluate an Extracellular Matrix (MatriStem®) for the Treatment of Diabetic Foot Ulcers

NCT02750280 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2016-04-25

No results posted yet for this study

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.

Conditions

  • Neuropathic Diabetic Foot Ulcer

Interventions

DEVICE

MatriStem® [Urinary Bladder Matrix (UBM)]

Porcine derived urinary bladder extracellular matrix

DEVICE

Mepilex® [Silicone foam dressing]

primary wound dressing

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    collaborator INDUSTRY

  • Calvary Hospital, Bronx, NY

    lead OTHER

Principal Investigators

  • oscar Alvarez, PhD · Calvary Hospital Director, Center for curative and palliative wound care

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
2015-06-30
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 NCT02750280 on ClinicalTrials.gov