Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use

NCT01840085 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2017-12-12

No results posted yet for this study

Summary

To evaluate the safety of topical 0.03% DSC127 Gel when used for one or more continuous treatment periods on a chronic Wagner Grade 1 or 2 foot ulcer(target ulcer) or multiple ulcers in diabetic subjects. The maximum duration of any treatment period is 24 weeks.

Conditions

  • Diabetic Foot Ulcer

Interventions

DRUG

0.03% DSC127 topical gel

Sponsors & Collaborators

  • Integrium

    collaborator INDUSTRY
  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • John Caminis, MD · Integra LifeSciences Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
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 NCT01840085 on ClinicalTrials.gov