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
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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