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Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers

NCT01181440 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2018-05-21

No results posted yet for this study

Summary

This study randomly assigns patients with plantar diabetic foot ulcers to receive conventional therapy (debridement, infection control, saline-moistened gauze dressings, and standardized off-weighting) alone or conventional therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable polyglactin (Vicryl) mesh. Patients are evaluated weekly until Week 12, then every four weeks until Week 32.

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

Dermagraft(R)

Weekly application of Dermagraft(R) with conventional care

OTHER

Conventional care

Weekly application of conventional care

Sponsors & Collaborators

  • Organogenesis

    lead INDUSTRY

Principal Investigators

  • Richard A Pollak, DPM · San Antonio Podiatry Associates, San Antonio, TX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-09-30
Primary Completion
1997-01-31
Completion
1997-01-31

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 NCT01181440 on ClinicalTrials.gov