Phase III Study to Evaluate Efficacy and Safety of DSC127 in Diabetic Foot Ulcers (STRIDE 1)
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|ClinicalTrials.gov Identifier: NCT01830348|
Recruitment Status : Terminated
First Posted : April 12, 2013
Last Update Posted : December 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcers||Drug: DSC127 Drug: placebo vehicle gel||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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||266 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Subjects With Diabetes Mellitus|
|Study Start Date :||February 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 is sooner
Placebo Comparator: Vehicle gel
Vehicle gel comprising HEC with parabens
Drug: placebo vehicle gel
- 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.
- Time to the visit where the target ulcer achieves confirmed complete wound closure [ Time Frame: Weekly assessments to ten weeks post first treatment dose ]
- Percent reduction in ulcer area per week (closure rate) [ Time Frame: Weekly ulcer tracings to calculate area of ulcer, measurements continue to ten weeks post first treatment dose ]Calculated weekly for up to ten weeks
- Incidence of target ulcer recurrence, time to ulcer recurrence, and number of days target ulcer remains closed after confirmed complete wound closure has been established. [ Time Frame: Assessed during a 12 week durability period following the confirmation of complete wound closure ]
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): NCT01830348
|Study Director:||Gere S diZerega, MD||Integra LifeSciences Corporation|