A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer
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|ClinicalTrials.gov Identifier: NCT02667327|
Recruitment Status : Terminated (Sponsor Decision (No safety or efficacy concerns))
First Posted : January 28, 2016
Last Update Posted : May 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcers||Drug: Granexin gel Other: Vehicle gel||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Double-blind, Parallel-group, Vehicle Controlled, Multicenter Study of the Efficacy and Safety of Granexin Gel in the Treatment of Diabetic Foot Ulcer (GAIT 1)|
|Actual Study Start Date :||November 21, 2018|
|Actual Primary Completion Date :||May 27, 2020|
|Actual Study Completion Date :||May 27, 2020|
Active Comparator: Granexin gel plus Standard of Care
Granexin gel is comprised of 100 μM aCT1 peptide plus hydroxyethyl cellulose.
Drug: Granexin gel
Granexin gel contains active pharmaceutical ingredient, aCT1 peptide, for topical application to diabetic foot ulcers once a week for up to 12 weeks or until wound closure, whichever comes first.
Other Name: Granexin
Placebo Comparator: Vehicle gel plus Standard of Care
Vehicle gel is hydroxyethyl cellulose without active pharmaceutical ingredient.
Other: Vehicle gel
The vehicle gel formulation is hydroxyethyl cellulose that does not contain the active aCT1 peptide. Vehicle gel will be applied topically to diabetic foot ulcers once a week for up to 12 weeks or until wound closure, whichever comes first.
Other Name: Control
No Intervention: Standard of Care
Standard of Care includes cleaning and irrigating ulcer, non-surgical debridement, pain management, ulcer dressing, off-loading, and nutritional assessment.
- Incidence of complete wound closure at Week 12 based on investigator assessment [ Time Frame: Week 12 ]
- Time in days to first complete wound closure of the target ulcer based on investigator assessment over the 12 week treatment period [ Time Frame: Week 12 ]
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): NCT02667327