Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use (STRIDE 5)
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|ClinicalTrials.gov Identifier: NCT01840085|
Recruitment Status : Terminated
First Posted : April 25, 2013
Last Update Posted : December 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer||Drug: 0.03% DSC127 topical gel||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||261 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label Phase III Clinical Trial to Evaluate the Safety of 0.03% DSC127 Gel in Chronic Use for Treating Diabetic Foot Ulcers ("DFU")|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
|Experimental: 0.03% DSC127 topical gel||
Drug: 0.03% DSC127 topical gel
- The proportion of all subjects reporting Adverse Events and Serious Adverse Events related to study treatment [ Time Frame: 2.5yrs ]
- Changes from baseline in laboratory evaluations (clinically significant changes) [ Time Frame: 2.5yrs ]
- Proportion of all subjects treated and terminating prematurely due to adverse events related to study treatment. [ Time Frame: 2.5yrs ]
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): NCT01840085
|Study Director:||John Caminis, MD||Integra LifeSciences Corporation|