A Study of Granexin Gel to Treat Diabetic Foot Ulcer

STATUS

Recruiting
participants needed

368
sponsor

FirstString Research, Inc.

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Updated on 8 November 2020

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diabetes

debridement

hemoglobin a1c

foot ulcer

Summary

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

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 2 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.

Details

Condition	Diabetic Foot
Treatment	Vehicle gel, Granexin gel
Clinical Study Identifier	NCT02666131
Sponsor	FirstString Research, Inc.
Last Modified on	8 November 2020

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age 18 years or older
	Established diagnosis of diabetes mellitus (type I or II)
	Glycosylated hemoglobin (HbA1c) value < 10.0% at the screening visit
	Diagnosis of neuropathic foot ulcer by 10g monofilament test, tuning fork (128 Hz), cotton wisp, or quantitative sensory test
	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. Diameter (after debridement) 1 to 40.0 cm2; e. Viable, granulating wound (investigator discretion)
	Ankle brachial index 0.7 to 1.3 at both the screening and baseline visits
	Signed informed consent
	Female patients of childbearing potential must have a negative pregnancy test at screening and must agree to use hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence throughout until 2 weeks after the last administration of study drug
Exclusion Criteria
	Change (decrease or increase) in size of the designated target ulcer by 30% during the 7-day screening period
	Cannot tolerate the off-loading method or cannot comply with study-defined standard-of-care treatment
	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 operative debridement; c. Is positive for -hemolytic streptococci upon culture; d. Has > 50% slough, significant necrotic tissue, bone, tendon, or capsule exposure; e. Is highly exuding (i.e., requires daily change of dressing)
	Requires total contact cast
	Ankle brachial pressure index < 0.7 or > 1.3 or ankle systolic pressure < 70 mmHg
	Has a local or systemic infection or local erythema 0.5 cm
	Has any 1 of the following (only 1 of the 3 tests is required): a. On Doppler waveform analysis of the dorsalis pedis and posterior tibial arteries, a monophasic or biphasic flow (with loss of reverse flow) in either the artery of either foot; b. Toe:brachial index < 0.75 or > 1.3
	Transcutaneous oxygen pressure < 40 mmHg
	Presence of active systemic or local cancer or tumor of any kind (exception: nonmelanoma skin cancer allowable at investigator discretion)
	Congestive heart failure (New York Heart Association class II-IV) or coronary heart disease with ST segment elevation myocardial infarction or coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the last 6 months
	Active osteomyelitis of the foot with the target ulcer detected by x-ray, CT scan, or MRI
	Active connective tissue disease
	Acute Charcot's neuro-arthropathy as determined by clinical and/or radiographic examination
	Active treatment with systemic corticosteroids
	Previous or current radiation therapy to the distal lower extremity or likelihood to receive this therapy during study participation
	Pregnant or nursing
	Uncontrolled anemia (hemoglobin < 10 g/dL in females and < 12 g/dL in males)
	Estimated glomerular filtration rate < 25 mL/min
	Poor nutritional status, defined as an albumin < 25 g/L (< 2,500 mg/dl)
	Significant peripheral edema as per investigator's discretion
	Known inability or unavailability to complete required study visits during study participation
	A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the patient's medical history, which, in the opinion of the investigator, may pose a threat to patient compliance
	Use of a platelet-derived growth factor within 28 days before screening
	Use of any investigational drug or therapy within 28 days before screening
	Has any other factor which may, in the opinion of the investigator, compromise participation and/or follow-up in the study

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A Study of Granexin Gel to Treat Diabetic Foot Ulcer