Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Venous Leg Ulcers

Completed · Phase 1

Conditions studied: Venous Leg Ulcer

In brief

The purpose of this study is to determine the systemic exposure of Granexin® gel after topical application to human subjects' venous leg ulcers.

Key facts

Study ID

NCT02652572

Run by

Xequel Bio, Inc.

People needed

10

Starts

2015-09-01

Expected to finish

2018-05-01

Last updated by the study team

2018-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Diagnosis of venous leg ulcer(s), as clinically determined by the investigator by a positive venous reflux test (venous refilling <20 seconds) using Doppler ultrasound for at least 4 weeks prior to screening day, which have not adequately responded to conventional ulcer therapy.
• Designated venous leg ulcer meets the following criteria at both the screening and baseline visits. If the patient has multiple ulcers, at least one ulcer must meet the following criteria at both the screening and baseline visits:
• Present for at least 4 weeks
• CEAP Classification Stage 6
• Surface ulcer with an area > 15cm2 post debridement
• Viable, granulating wound (investigator discretion)
• Ulcers that extend through the epidermis but not through the muscle, tendon, or bone (Stage II or III ulcers as defined by the IAET).
• 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
• Signed informed consent

You may not qualify if…

• Decrease in size of the designated target ulcer(s) by ≥ 30% during the 7-day screening period
• Cannot tolerate or comply with compression therapy.
• An ulcer which shows signs of severe clinical infection, defined as pus oozing from the ulcer site
• An ulcer positive for β-hemolytic streptococci upon culture
• The ulcer has > 50% slough, significant necrotic tissue, bone, tendon, or capsule exposure or avascular ulcer beds
• Is highly exuding (i.e. requires daily change of dressing)
• Ankle brachial pressure index <0.65
• Patients with active systemic infections
• Patients with clinically significant medical conditions as determined by the investigator including renal, hepatic, hematologic, neurologic or immune disease. Examples include but are not limited to:
• Renal insufficiency as an estimated GFR which is < 30 mL/min/1.7m2
• Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range.
• Hepatic insufficiency defined as total bilirubin > 2 mg/dL or serum albumin < 25 g/L
• HbA1c > 9%
• Hemoglobin < 10 g/dL
• Hematocrit < 0.30
• Platelet count < 100,000
• Presence of an active systemic or local cancer or tumor of any kind (with the exception of non-melanoma skin cancer)
• Patients with severe rheumatoid arthritis (with more than 20 persistently inflamed joints, or below lower normal limit blood albumin level, or evidence of bone and cartilage damage on x-ray, or inflammation in tissues other than joints) and other collagen vascular diseases.
• Patients with active connective tissue disease
• Treatment with systemic corticosteroids (>15 mg/day), or current immunosuppressive agents
• Previous or current radiation therapy or likelihood to receive this therapy during study participation
• Pregnant or nursing patients
• Known prior inability or unavailability to complete required study visits during study participation
• Significant peripheral edema as per investigator's discretion
• 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

Where it is running

• Aiyan Diabetes Center — Augusta, Georgia, United States
• Spartanburg Regional Healthcare System — Spartanburg, South Carolina, United States
• Salem VA Medical Center — Salem, Virginia, United States

Full record on ClinicalTrials.gov

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