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Phase III Study to Evaluate Efficacy and Safety of DSC127 in Diabetic Foot Ulcers

NCT01830348 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2017-12-12

No results posted yet for this study

Summary

The purpose of the study is to determine if DSC127 is effective in increasing incidence of complete wound closure at 10 weeks confirmed at a visit 2 weeks later when compared to the vehicle (gel without active ingredient) in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 0.75 - 6 cm2 in size.

Conditions

  • Diabetic Foot Ulcers

Interventions

DRUG

DSC127

DSC127 0.03%, daily topical application to diabetic foot ulcer for a period of up to 28 days or until ulcer closure, whichever is sooner

DRUG

placebo vehicle gel

Sponsors & Collaborators

  • Integrium

    collaborator INDUSTRY

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Gere S diZerega, MD · Integra LifeSciences Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-12-31
Completion
2015-12-31

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 NCT01830348 on ClinicalTrials.gov