NCT01849965

Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers

A Randomized, Double-Blind, Parallel-group, Vehicle and Standard of Care-controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DSC127 in Treating Non-healing Foot Ulcers in Subjects With Diabetes Mellitus

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 396 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine if aclerastide (DSC127) is effective in increasing incidence of complete wound closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active ingredient) and compared with a standard-of-care gel, in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 diabetic foot ulcers, 0.75 - 6cm2 in size.

Detailed description

Subjects will undergo a two week screening period to assess plantar ulcer healing, and those healing less than 30% will be eligible for randomization providing all other criteria are met. Four weeks of "blinded" randomized treatment follows the screening period, and an observation period of six weeks follows the treatment period. If the ulcer closes during the treatment or observation period, the closure will be confirmed at a visit two weeks later, and at this time the subjects enters a durability assessment period of up to 12 weeks. All aspects of Standard of Care are followed throughout the study period.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
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 occurs sooner.
DRUG	placebo vehicle gel
DRUG	Standard of Care gel, Aquasite

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-05-09
• Last updated: 2017-12-12

Locations

56 sites across 4 countries: United States, Canada, Puerto Rico, South Africa