Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers (STRIDE 2)
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|ClinicalTrials.gov Identifier: NCT01849965|
Recruitment Status : Terminated
First Posted : May 9, 2013
Last Update Posted : December 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcers||Drug: DSC127 Drug: placebo vehicle gel Drug: Standard of Care gel, Aquasite||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||396 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Active Comparator: DSC127
DSC127 0.03% in a vehicle gel (hydroxyethyl cellulose (HEC) with parabens)
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.
Placebo Comparator: Vehicle gel
Vehicle gel comprising HEC with parabens
Drug: placebo vehicle gel
Placebo Comparator: Standard of Care gel
Aquasite gel, as standard of care gel
Drug: Standard of Care gel, Aquasite
- The proportion of subjects with a target ulcer which achieves complete wound closure by 10 weeks (confirmed 2 weeks later) after initiation of treatment. [ 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 via tracings submitted to the Canfield system, and photographs are collected as confirmation of closure via the Canfield system. Assessment of aclerastide (DSC127) vs vehicle control.
- The proportion of subjects with a target ulcer which achieves complete wound closure by 10 weeks (confirmed two weeks later) after initiation of treatment. [ 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 calculated via tracings submitted to the Canfield system, and photographs are collected as confirmation of closure via the Canfield system. Assessment of aclerastide (DSC127) vs Standard of Care control.
- Time to the visit where the target ulcer achieves confirmed complete wound closure [ Time Frame: Measurements to ten weeks post first dose ]
- Percent reduction in target ulcer area per week. [ Time Frame: Up to ten weeks post first dose ]
- Incidence of and time to target ulcer recurrence after confirmed complete wound closure has been established. [ Time Frame: To a maximum of 24 weeks post first dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849965
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|Study Director:||Alan Dunton, MD||Integra LifeSciences Corporation|