A Study of Granexin Gel to Treat Diabetic Foot Ulcer

  • participants needed
  • sponsor
    FirstString Research, Inc.
Updated on 8 November 2020
hemoglobin a1c
foot ulcer


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


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.

Condition Diabetic Foot
Treatment Vehicle gel, Granexin gel
Clinical Study IdentifierNCT02666131
SponsorFirstString Research, Inc.
Last Modified on8 November 2020


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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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