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A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers

NCT01060670 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 545

Last updated 2016-09-22

Study results available
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Summary

The objective of this study is to evaluate the safety and efficacy of the INTEGRA® Dermal Regeneration Template for the treatment of diabetic foot ulcers located distal to the malleolus in subjects with diabetes mellitus, neuropathy, and without significantly compromised arterial circulation.

Conditions

  • Neuropathic Diabetic Ulcer - Foot

Interventions

DEVICE

Integra® Dermal Regeneration Template

Application of Integra® Dermal Regeneration Template in diabetic foot ulcer

OTHER

Conventional Wound Therapy

Conventional Wound Therapy

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States
  • Netherlands Antilles

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 NCT01060670 on ClinicalTrials.gov