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A Study to Assess the Effect of Topical Recombinant Human Vascular Endothelial Growth Factor for Induction of Healing of Diabetic Foot Ulcers

NCT00351767 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2013-01-25

No results posted yet for this study

Summary

This is a Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of three different doses of topically applied telbermin in subjects ≥ 18 years old with diabetic foot ulcers. Approximately 160 adult subjects with Type 1 or Type 2 diabetes mellitus will be enrolled at approximately 40 investigational sites in the United States and Canada.

Conditions

  • Foot Ulcer, Diabetic

Interventions

DRUG

placebo

Topically applied

DRUG

telbermin

Topically applied

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Pual Kwon, M.D. · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-01-31

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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 NCT00351767 on ClinicalTrials.gov