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Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers

NCT01181453 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2018-05-21

No results posted yet for this study

Summary

This study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 12-week treatment period is complete.

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

Dermagraft

Weekly application of Dermagraft(R) with standard care

OTHER

Comparator

Weekly application of standard care

Sponsors & Collaborators

  • Organogenesis

    lead INDUSTRY

Principal Investigators

  • William A Marston, MD · University of North Carolina School of Medicine, Chapel Hill, NC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-12-31
Primary Completion
2000-03-31
Completion
2000-03-31

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 NCT01181453 on ClinicalTrials.gov