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A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers

NCT01270633 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-12-02

No results posted yet for this study

Summary

The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation.

Conditions

  • Foot Ulcer, Diabetic

Interventions

DEVICE

PriMatrix

Following sharp debridement, application of PriMatrix dermal repair scaffold in conjunction with moist wound therapy

OTHER

Standard of Care

Following sharp debridement, moist wound therapy

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Yiannis Monovoukas, PhD · TEI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • United States
  • Puerto Rico

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 NCT01270633 on ClinicalTrials.gov