Diabetic Foot UlcersPhase 3NCT02667327
A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer
A Phase 3 study testing Granexin gel in people with Diabetic Foot Ulcers, run by Xequel Bio, Inc. at 29 sites in 5 countries.
Trial summary
The purpose of this study is to determine whether Granexin gel is safe and effective in the treatment of diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- Granexin gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 29 sitesin 5 countries
- Study dates
- 21 Nov 2018to 27 May 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female participants may participate in the study.
- To be eligible for entry into this study, a patient must meet all of the following Inclusion criteria:
- 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
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- 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.
- 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 investigational product. Male patients must also agree to use contraception such as a condom.
Who cannot join
- Patients will not be eligible for enrollment in the study if they meet any of the exclusion criterial listed below:
- 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
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- 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)
- Congestive heart failure (New York Heart Association class II-IV)
- 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 or chronic Charcot's neuro-arthropathy as determined by clinical and/or radiographic examination
- Active treatment with systemic corticosteroids or topical corticosteroids (for treatment of the target ulcer or any area of the foot). This does not include inhaled corticosteroids used for conditions other than treating the target ulcer or any area of the foot. Wash out period for systemic corticosteroids is 14 days for inclusion in this study. Wash out period for topical corticosteroids (for treatment of the target ulcer or any area of the foot) is 14 days for inclusion in the study)
- Active treatment with systemic antibiotics (wash out period for systemic antibiotics is 7 days for the inclusion in the study)
- Previous or current radiation therapy to the distal lower extremity or likelihood to receive this therapy during study participation
- Pregnant or nursing mothers
- 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 of a patient 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
Trial locations and contacts
29 sites in 5 countries.
29 sites in 5 countries
India16 sites
Shrey Hospital Pvt Ltd
Ahmedabad, Gujarat, 380009
Parul Sevashram Hospitals
Ahmedabad, Gujarat, 390020
KLEs Dr. Prabakar Kore Hospital and Medical Research Center
Belagavi
Peoples College of Medical Science and Research Centre
Bhopal
Marwari Hospital and Research Centre
Guwahati
Surakshaka MultiSpecialty and Diabetes Hospital
Hyderabad
Convenient Hospitals Ltd., CHL - Hospitals
Indore, Madhya Pradesh, 452008
KRM Hospital and Research Center
Lucknow
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow
Fortis Hospital
Mohali
K R Hospital and Research Institute
Mysore
Supe Heart and Diabetes Hospital and Research Centre
Nashik
Batra Hospital and Medical Research Center
New Delhi
Anand Multispecialty Hospital
Vadodara, Gujarat, 390016
Aman Hospital and Research Centre
Vadodara
Anu Hospitals, Kovelamudivara Street
Vijayawada
United States6 sites
Integral - Clinical Trials Solutions
Doral, Florida, 33126
Acclaim Bone & Joint
Fort Worth, Texas, 76104
Direct Helpers Research Center
Hialeah, Florida, 33012
New Hope Podiatry Group, Inc.
Los Angeles, California, 90063
Futuro Clinical Trials, LLC
McAllen, Texas, 78501
Nirvana Research Center
Miami, Florida, 33193
Poland4 sites
Lubuskie Centrum Diabetologii UI.
Budziszynek, Zielon, 20 65-945
MIKOMED Sp. z o.o. ul.
Lodz, Łódź .Pługowa, 51 94-238
Instytut Medycyny Wsi - oddz diabetologii ul. Jaczewskiego 2, 20-090 Lublin, Poland
Lublin, Jaczewskiego, 20-090
NZOZ MED ART. Poradnie Specjalistyczne Ks. Wladyslawa 27, 44-240 Zory, Poland
Żory, Wladyslawa 27, 44-240
Hungary2 sites
Clinexpert Kft. - Kaszasdulo utca 5.
Budapest, 1033
Strazsahegy Medicina Bt., Zrinyi utca 226
Budapest, 1171
Canada1 site
Centre podiatrique et soins des plaies
Boucherville, Quebec, J4B 5E4
About this study
Official title: A Phase 3, Randomized, Double-blind, Parallel-group, Vehicle Controlled, Multicenter Study of the Efficacy and Safety of Granexin Gel in the Treatment of Diabetic Foot Ulcer (GAIT 1)
The purpose of this study is to determine whether Granexin gel is safe and effective in the treatment of diabetic foot ulcers.
Read the detailed description
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 3 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.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Granexin gel, Vehicle gel
- Keywords
- diabetic foot ulcer, diabetic complications, diabetes, wound healing, Granexin gel, FirstString Research
- Medical subject headings
- Diabetic Foot, Diabetes Complications, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granexin gelDrug
Also called Granexin
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.
Vehicle gelOther
Also called Control
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.
| Study group | Role | What they receive |
|---|---|---|
| Granexin gel plus Standard of Care | Active comparator | Granexin gel is comprised of 100 μM aCT1 peptide plus hydroxyethyl cellulose. Receives: Drug: Granexin gel |
| Vehicle gel plus Standard of Care | Placebo comparator | Vehicle gel is hydroxyethyl cellulose without active pharmaceutical ingredient. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complete wound closure at Week 12 based on investigator assessment
Measured: 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
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study start21 Nov 2018
- Primary completion27 May 2020
- Study completion27 May 2020
Why it stopped: Sponsor Decision (No safety or efficacy concerns)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xequel Bio, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667327
- Sponsor's protocol ID
- 2015-DFU-301
- Status last verified
- May 2020
- First submitted
- 26 Jan 2016
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Parallel-group, Vehicle Controlled, Multicenter Study of the Efficacy and Safety of Granexin Gel in the Treatment of Diabetic Foot Ulcer (GAIT 1)
- ClinicalTrials.gov ID
- NCT02667327
- Acronym / sponsor ID
- 2015-DFU-301
- Conditions
- Diabetic Foot Ulcers
- Keywords
- diabetic foot ulcer, diabetic complications, diabetes, wound healing, Granexin gel, FirstString Research
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision (No safety or efficacy concerns)
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Xequel Bio, Inc.University, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 27 May 2020 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Granexin gel is safe and effective in the treatment of diabetic foot ulcers.
Detailed description
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 3 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Granexin gel plus Standard of Care | Active comparator | Drug: Granexin gelGranexin gel is comprised of 100 μM aCT1 peptide plus hydroxyethyl cellulose. |
| Vehicle gel plus Standard of Care | Placebo comparator | Other: Vehicle gelVehicle gel is hydroxyethyl cellulose without active pharmaceutical ingredient. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Both male and female participants may participate in the study.
- To be eligible for entry into this study, a patient must meet all of the following Inclusion criteria:
- Age 18 years or older
- Established diagnosis of diabetes mellitus (type I or II)
- Glycosylated hemoglobin (HbA1c) value < 12.0% at the screening visit
Key exclusion criteria (34 listed)
- Patients will not be eligible for enrollment in the study if they meet any of the exclusion criterial listed below:
- 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:
- Requires total contact cast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Granexin gelAlso: GranexinGranexin 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. | Drug | Granexin gel plus Standard of Care |
| Vehicle gelAlso: ControlThe 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. | Other | Vehicle gel plus Standard of Care |
Primary outcome
Incidence of complete wound closure at Week 12 based on investigator assessment
Time frame: Week 12
1 secondary outcome
Time in days to first complete wound closure of the target ulcer based on investigator assessment over the 12 week treatment period
Time frame: Week 12
Results and safety
The study was stopped early (reason given: Sponsor Decision (No safety or efficacy concerns)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcers
Recruiting
PAW-Hydrogel for Chronic Wound Healing
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Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Granexin gel in people with Diabetic Foot Ulcers, run by Xequel Bio, Inc. at 29 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in India, United States, Poland, Hungary, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision (No safety or efficacy concerns)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complete wound closure at Week 12 based on investigator assessment (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020; AzTrials last refreshed its copy on 8 Nov 2026.