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Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers

NCT00796744 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2012-09-27

Study results available
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Summary

The purpose of this study is to assess if the experimental drug, DSC127, is safe, how well it can be tolerated, and how different doses effect the healing of the chronic foot ulcers in diabetic subjects.

Conditions

  • Foot Ulcer, Diabetic
  • Diabetic Foot

Interventions

DRUG

NorLeu3-A(1-7) in a gel formulation

Gel will be applied to the wound once daily for four weeks (treatment period). Gel will have either no active ingredient (placebo), 0.03% or 0.01% active ingredient.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Integra LifeSciences Corporation

    collaborator INDUSTRY

  • US Biotest, Inc.

    lead INDUSTRY

Principal Investigators

  • Gere diZerega, MD · US Biotest, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-12-31
Completion
2011-05-31

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 NCT00796744 on ClinicalTrials.gov