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Evaluation of Windowed Casts With and Without Regranex® Gel for Healing Diabetic Neuropathic Ulcers

NCT00446472 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-06-04

No results posted yet for this study

Summary

The objective of this study is to compare the effectiveness and safety of windowed casts with Regranex® (topical becaplermin gel) versus placebo (inactive medication) for treatment of diabetic ulcers on the legs and feet.

Conditions

  • Diabetic Foot Ulcers

Interventions

DRUG

Regranex®

Regranex gel will be used for a total of 16 weeks

DRUG

Hydrogel

Placebo hydrogel will be applied for 16 weeks

Sponsors & Collaborators

  • Heritage Medical Research Institute

    collaborator OTHER

  • Southern California Institute for Research and Education

    lead OTHER

Principal Investigators

  • Ian Gordon, M.D., Ph.D. · VA Long Beach Healthcare System

  • Aksone Nouvong, D.P.M. · VA Greater Los Angeles Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2010-09-30
Completion
2010-09-30

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 NCT00446472 on ClinicalTrials.gov