NCT02667327

A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Xequel Bio, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Granexin gel is safe and effective in the treatment of diabetic foot ulcers.

Detailed description

DFU patients will undergo a one week screening period and those with changes in ulcer size of less than 30% will be eligible for randomization providing all other criteria are met. Participants enrolled in the study will receive treatment based on randomization into 1 of 3 treatment arms for up to 12 weeks. The participants will have an additional 12 week follow-up period beyond the treatment period to assess durability of wound closure.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2018-11-21
• Primary completion: 2020-05-27
• Completion: 2020-05-27
• First posted: 2016-01-28
• Last updated: 2020-05-29

Locations

29 sites across 5 countries: United States, Canada, Hungary, India, Poland

Regulatory

• FDA-regulated drug study