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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Randomized, Double-blind, Parallel-group, Vehicle-controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DSC127 in Treating Non-healing Foot Ulcers in

Brief 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.

Detailed Summary:

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 they meet all other inclusion criteria. Four weeks of blinded "treatment" follows the screening period, and an observation period of six weeks (to 10 weeks post first treatment) follows the 4-week treatment period. If the ulcer closes during the treatment or observation period, the closure will be confirmed two weeks later, and at this time the subject enters a durability assessment period of up to 12 weeks.

All aspects of Standard of Care are followed throughout the study period.


Sponsor: Derma Sciences, Inc.

Current Primary Outcome: The proportion of subjects with a target ulcer which achieves complete wound closure (skin re-epithelialization without drainage or dressing requirements) up to 10 weeks (confirmed at a study visit 2 weeks later). [ Time Frame: Target ulcer must achieve complete wound closure by 10 weeks post first treatment ]

Primary endpoint of complete closure is assessed by the Principal Investigator at the site; ulcer measurements are calculated through tracings submitted to the Canfield system and photographs are collected as confirmation of closure via the Canfield system.


Original Primary Outcome: The proportion of subjects with a target ulcer which achieves complete wound closure (skin re-epithelialization without drainage or dressing requirements) up to 10 weeks (confirmed at a study visit 2 weeks later). [ Time Frame: Target ulcer must achieve complete wound closure by 10 weeks post first treatment ]

Primary endpoint of complete closure is assessed by the Principle Investigator at the site; ulcer measurements are assessed using the Canfield system and photographs are collected as confirmation of closure via the Canfield system.


Current Secondary Outcome: Time to the visit where the target ulcer achieves confirmed complete wound closure [ Time Frame: Weekly assessments to ten weeks post first treatment dose ]

Original Secondary Outcome: Percent reduction in ulcer area per week (closure rate), derived from the baseline-adjusted change from Baseline. [ Time Frame: Reduction in area is based on weekly ulcer tracings to calculate area of ulcer; measurements continue to ten weeks post first treatment dose. ]

This area will be calculated for the two periods: Treatment Period (up to 4 weeks) and the Treatment and Observation Periods (up to 10 weeks), as only subjects experiencing skin re-epithelialization without drainage or dressing requirements remain in the study beyond Week 10.


Information By: Derma Sciences, Inc.

Dates:
Date Received: March 15, 2013
Date Started: February 2013
Date Completion: June 2016
Last Updated: November 18, 2015
Last Verified: June 2015