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

NCT02652572 | Completed Phase 1 DMC

• 1 other identifier: VLU-PK-300
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Venous Leg Ulcer

Keywords

Granexin; venous leg ulcer; pharmacokinetic study; FirstString Research

Outcome Measures

Primary Outcomes (3)

• Measurement of aCT1 peptide (Active Pharmaceutical Ingredient in Granexin) levels in blood

  Day 0

• Measurement of aCT1 peptide (Active Pharmaceutical Ingredient in Granexin) levels in blood

  Day 3

• Measurement of aCT1 peptide (Active Pharmaceutical Ingredient in Granexin) levels in blood

  Day 7

Study Arms (1)

Granexin® gel plus standard-of-care

EXPERIMENTAL

Granexin® gel will be applied topically to diabetic foot ulcer(s) on Day 0 (baseline), Day 3, and Day 7. In addition, standard-of-care treatment will be applied to the ulcer(s) at Screening, Day 0, Day 3, and Day 7.

Drug: Granexin

Interventions

Granexin DRUG

Granexin® gel will be dispensed directly from a 5 gram laminate tube and will be spread and smoothed directly over the wound surface in full contact with the wound bed to obtain an even, uniform layer on Day 0 (baseline), Day 3, and Day 7.

Granexin® gel plus standard-of-care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Xequel Bio, Inc.: lead
• Spartanburg Regional Healthcare System: collaborator
• Medical University of South Carolina: collaborator

Study Sites (3)

Aiyan Diabetes Center

Augusta, Georgia, 30907, United States

Location

Spartanburg Regional Healthcare System

Spartanburg, South Carolina, 29303, United States

Location

Salem VA Medical Center

Salem, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 12, 2016
• Study Start: September 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2018
• Last Updated: August 1, 2018

Record last verified: 2018-07

Locations

US (3)