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

FirstString Research Inc0 sites0 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sponsor

•1\. Age 18 years or older
•2\. Established diagnosis of diabetes mellitus (type I or II)
•3\. Glycosylated hemoglobin (HbA1c) value \< 10\.0% at the screening visit
•4\. Diagnosis of neuropathic foot ulcer by 10 g monofilament test, tuning fork, or cotton wisp
•5\. Designated foot ulcer meets the following criteria at both the screening and baseline visits: a. Present for at least 4 weeks
•b. Full\-thickness cutaneous ulcer below the ankle surface
•c. University of Texas grade A1
•d. Wound area (after debridement) 1 to 40\.0 cm2
•e. Viable, granulating wound (investigator discretion)
•6\. Ankle brachial index \>\= 0\.7 at both the screening and baseline visits. If the ABI is \> 1\.30, one of the following confirmatory tests must be performed for the patient to be considered eligible:

•1\. Change (decrease or increase) in size of the designated target ulcer by greater than or equal to 30 percent during the 7\-day screening period
•2\. Cannot tolerate off\-loading methods or cannot comply with study related procedures
•3\. Has an ulcer that meets any of the following criteria:
•a. Shows signs of severe clinical infection, defined as pus oozing from the ulcer site
•b. Requires surgical debridement
•c. Is positive for Î²\-hemolytic streptococci upon culture performed prior to screening debridement procedure.
•d. Has greater than 50 percent slough, significant necrotic tissue, bone, tendon, or capsule exposure
•e. Is highly exuding (i.e., requires daily change of dressing)
•4\. Requires total contact cast
•5\. Ankle brachial pressure index less than 0\.7

Not specified