Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Diabetic Foot Ulcers

NCT02652754 | Completed Phase 1 DMC

• 1 other identifier: DFU-PK-300
• Study Type: interventional
• Target: 16
• 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' diabetic foot ulcers.

Conditions

Diabetic Foot Ulcers

Keywords

Granexin; diabetic foot ulcers; 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

OTHER

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® gel

Interventions

Granexin® gel 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 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(s)
• Designated foot ulcer meets the following criteria at both the screening an baseline visits. If the patient has multiple ulcers, at least one ulcer must meet 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) Area (after debridement) \> 4 square cm; 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.

You may not qualify if:

• Decrease in size of the designated target ulcer(s) by ≥ 30% during the 7-day screening period.
• Impaired cognition determined by clinical investigator
• 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) Is positive for β-hemolytic streptococci upon culture; c) Has \> 50% slough, significant necrotic tissue, bone, tendon, or capsule exposure; d) 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 systemic infection
• 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: bracial index \< 0.7 or \> 1.3; c) Transcutaneous oxygen pressure \< 40 mmHg
• Presence of active systemic or local cancer or tumor of any king (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(s)
• Active connctive 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.

Sponsors & Collaborators

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

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

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)