Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers

NCT00512538 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2007-08-07

No results posted yet for this study

Summary

The purpose of this study is to determine the ability of Apligraf to improve the time to and incidence of complete wound closure of diabetic foot ulcers, as compared to diabetic foot ulcers treated with standard therapy.

Conditions

  • Diabetic Foot

Interventions

DEVICE

Bi-layered cell therapy (Apligraf)

Sponsors & Collaborators

  • Organogenesis

    lead INDUSTRY

Principal Investigators

  • Michael E Edmonds, MD · Diabetic Foot Clinic, Kings College Hospital, London UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-10-31
Completion
2002-09-30

More Related Trials

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 NCT00512538 on ClinicalTrials.gov