NCT01840085

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

Open-Label Phase III Clinical Trial to Evaluate the Safety of 0.03% DSC127 Gel in Chronic Use for Treating Diabetic Foot Ulcers ("DFU")

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All eligible subjects enrolled will begin daily Treatment with topical 0.03% DSC127 gel until complete wound closure (defined as skin re-epithelialization without drainage or dressing requirement) or 24 weeks, whichever occurs first. If a patient has multiple ulcers on one foot, all may be treated, within the maximum of 24 weeks. If the ulcer does not heal, after a wash out period of 1 week, a new treatment period of up to 24 weeks may be initiated. Ulcer may be retreated if it recurs or if a new ulcer develops that meets study criteria. For the entire duration of each treatment period the standard of care for DFU will be maintained.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DRUG	0.03% DSC127 topical gel

Timeline

• Start date: 2015-12-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-04-25
• Last updated: 2017-12-12

Locations

21 sites across 1 country: United States