A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer

NCT02667327 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: 2015-DFU-301
• Study Type: interventional
• Target: 124
• Locations: 5 countries
• Sites: 29

Brief Summary

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

Conditions

Diabetic Foot Ulcers

Keywords

diabetic foot ulcer; diabetic complications; diabetes; wound healing; Granexin gel; FirstString Research

Outcome Measures

Primary Outcomes (1)

• Incidence of complete wound closure at Week 12 based on investigator assessment

  Week 12

Secondary Outcomes (1)

• Time in days to first complete wound closure of the target ulcer based on investigator assessment over the 12 week treatment period

  Week 12

Study Arms (3)

Granexin gel plus Standard of Care

ACTIVE COMPARATOR

Granexin gel is comprised of 100 μM aCT1 peptide plus hydroxyethyl cellulose.

Drug: Granexin gel

Vehicle gel plus Standard of Care

PLACEBO COMPARATOR

Vehicle gel is hydroxyethyl cellulose without active pharmaceutical ingredient.

Other: Vehicle gel

Standard of Care

NO INTERVENTION

Standard of Care includes cleaning and irrigating ulcer, non-surgical debridement, pain management, ulcer dressing, off-loading, and nutritional assessment.

Interventions

Granexin gel DRUG

Granexin gel contains active pharmaceutical ingredient, aCT1 peptide, for topical application to diabetic foot ulcers once a week for up to 12 weeks or until wound closure, whichever comes first.

Also known as: Granexin

Granexin gel plus Standard of Care

Vehicle gel OTHER

The vehicle gel formulation is hydroxyethyl cellulose that does not contain the active aCT1 peptide. Vehicle gel will be applied topically to diabetic foot ulcers once a week for up to 12 weeks or until wound closure, whichever comes first.

Also known as: Control

Vehicle 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:

• Both male and female participants may participate in the study.
• Age 18 years or older
• Established diagnosis of diabetes mellitus (type I or II)
• Glycosylated hemoglobin (HbA1c) value \< 12.0% at the screening visit
• Diagnosis of neuropathic foot ulcer by 10g monofilament test, tuning fork (128 Hz), or cotton wisp
• Designated foot ulcer meets the following criteria at both the screening and baseline visits:
• Present for at least 4 weeks
• Full-thickness cutaneous ulcer below the ankle surface
• University of Texas grade A1
• Wound area (after debridement) 1 to 40.0 cm2
• Viable, granulating wound (investigator discretion)
• Ankle brachial index ≤ 0.7 at both the screening and baseline visits. If the ABI is \>1.30, one of the following confirmatory tests must be performed for the patient to be considered eligible:
• Does Not have a monophonic or biphasic flow (with the loss of reverse flow) in the artery of the foot with the target ulcer via doppler waveform analysis of the dorsalis pedis and posterior tibial arteries, as determined by standard practices of the investigator and the site.
• Transcutaneous oxygen pressure (TcPO2) at the foot \>40 mmHg
• Additionally, patients must meet all other protocol-defined eligibility criteria.

You may not qualify if:

• Change (decrease or increase) in size of the designated target ulcer by ≥ 30% during the 7-day screening period
• Cannot tolerate the off-loading methods or cannot comply with study related procedures
• Has an ulcer that meets any of the following criteria:
• Shows signs of severe clinical infection, defined as pus oozing from the ulcer site
• Requires surgical debridement
• Is positive for β-hemolytic streptococci upon culture performed prior to screening debridement procedure
• Has \> 50% slough, significant necrotic tissue, bone, tendon, or capsule exposure
• Is highly exuding (i.e., requires daily change of dressing)
• Requires total contact cast
• Ankle brachial pressure index \< 0.7
• Has a local or systemic infection or local lymphangitis ≥ 0.5 cm
• Has any 1 of the following (only 1 of the 2 tests is required):
• A monophasic or biphasic flow (with loss of reverse flow) in the artery of the foot with the target ulcer via doppler waveform analysis of the dorsalis pedis and posterior tibial arteries
• Transcutaneous oxygen pressure (TcPO2) at the foot \<40 mgHg
• Presence of active malignant or benign tumor of any kind, (with the exception to nonmelanoma skin cancer as per investigator's discretion)

Sponsors & Collaborators

• Xequel Bio, Inc.: lead

Study Sites (29)

New Hope Podiatry Group, Inc.

Los Angeles, California, 90063, United States

Location

Integral - Clinical Trials Solutions

Doral, Florida, 33126, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

Nirvana Research Center

Miami, Florida, 33193, United States

Location

Acclaim Bone & Joint

Fort Worth, Texas, 76104, United States

Location

Futuro Clinical Trials, LLC

McAllen, Texas, 78501, United States

Location

Centre podiatrique et soins des plaies

Boucherville, Quebec, J4B 5E4, Canada

Location

Clinexpert Kft. - Kaszasdulo utca 5.

Budapest, 1033, Hungary

Location

Strazsahegy Medicina Bt., Zrinyi utca 226

Budapest, 1171, Hungary

Location

Shrey Hospital Pvt Ltd

Ahmedabad, Gujarat, 380009, India

Location

Parul Sevashram Hospitals

Ahmedabad, Gujarat, 390020, India

Location

Anand Multispecialty Hospital

Vadodara, Gujarat, 390016, India

Location

Convenient Hospitals Ltd., CHL - Hospitals

Indore, Madhya Pradesh, 452008, India

Location

KLEs Dr. Prabakar Kore Hospital and Medical Research Center

Belagavi, India

Location

Peoples College of Medical Science and Research Centre

Bhopal, India

Location

Marwari Hospital and Research Centre

Guwahati, India

Location

Surakshaka MultiSpecialty and Diabetes Hospital

Hyderabad, India

Location

KRM Hospital and Research Center

Lucknow, India

Location

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, India

Location

Fortis Hospital

Mohali, India

Location

K R Hospital and Research Institute

Mysore, India

Location

Supe Heart and Diabetes Hospital and Research Centre

Nashik, India

Location

Batra Hospital and Medical Research Center

New Delhi, India

Location

Aman Hospital and Research Centre

Vadodara, India

Location

Anu Hospitals, Kovelamudivara Street

Vijayawada, India

Location

Instytut Medycyny Wsi - oddz diabetologii ul. Jaczewskiego 2, 20-090 Lublin, Poland

Lublin, Jaczewskiego, 20-090, Poland

Location

NZOZ MED ART. Poradnie Specjalistyczne Ks. Wladyslawa 27, 44-240 Zory, Poland

Żory, Wladyslawa 27, 44-240, Poland

Location

Lubuskie Centrum Diabetologii UI.

Budziszynek, Zielon, 20 65-945, Poland

Location

MIKOMED Sp. z o.o. ul.

Lodz, Łódź .Pługowa, 51 94-238, Poland

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Complications; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: January 28, 2016
• Study Start: November 21, 2018
• Primary Completion: May 27, 2020
• Study Completion: May 27, 2020
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (6); PL (4); HU (2); IN (16)