Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02667327
Recruitment Status : Terminated (Sponsor Decision (No safety or efficacy concerns))
First Posted : January 28, 2016
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
FirstString Research, Inc.

Tracking Information
First Submitted Date  ICMJE January 26, 2016
First Posted Date  ICMJE January 28, 2016
Last Update Posted Date May 29, 2020
Actual Study Start Date  ICMJE November 21, 2018
Actual Primary Completion Date May 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
Incidence of complete wound closure at Week 12 based on investigator assessment [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer
Official Title  ICMJE 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)
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Foot Ulcers
Intervention  ICMJE
  • Drug: Granexin gel
    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.
    Other Name: Granexin
  • Other: Vehicle gel
    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.
    Other Name: Control
Study Arms  ICMJE
  • Active Comparator: Granexin gel plus Standard of Care
    Granexin gel is comprised of 100 μM aCT1 peptide plus hydroxyethyl cellulose.
    Intervention: Drug: Granexin gel
  • Placebo Comparator: Vehicle gel plus Standard of Care
    Vehicle gel is hydroxyethyl cellulose without active pharmaceutical ingredient.
    Intervention: Other: Vehicle gel
  • No Intervention: Standard of Care
    Standard of Care includes cleaning and irrigating ulcer, non-surgical debridement, pain management, ulcer dressing, off-loading, and nutritional assessment.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 24, 2020)
124
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2016)
552
Actual Study Completion Date  ICMJE May 27, 2020
Actual Primary Completion Date May 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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:

  1. Age 18 years or older
  2. Established diagnosis of diabetes mellitus (type I or II)
  3. Glycosylated hemoglobin (HbA1c) value < 12.0% at the screening visit
  4. Diagnosis of neuropathic foot ulcer by 10g monofilament test, tuning fork (128 Hz), or cotton wisp
  5. Designated foot ulcer meets the following criteria at both the screening and baseline visits:

    1. Present for at least 4 weeks
    2. Full-thickness cutaneous ulcer below the ankle surface
    3. University of Texas grade A1
    4. Wound area (after debridement) 1 to 40.0 cm2
    5. Viable, granulating wound (investigator discretion)
  6. 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:

    1. 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.
    2. Transcutaneous oxygen pressure (TcPO2) at the foot >40 mmHg

    Additionally, patients must meet all other protocol-defined eligibility criteria.

  7. Signed informed consent
  8. 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.

Exclusion Criteria:

Patients will not be eligible for enrollment in the study if they meet any of the exclusion criterial listed below:

  1. Change (decrease or increase) in size of the designated target ulcer by ≥ 30% during the 7-day screening period
  2. Cannot tolerate the off-loading methods or cannot comply with study related procedures
  3. Has an ulcer that meets any of the following criteria:

    1. Shows signs of severe clinical infection, defined as pus oozing from the ulcer site
    2. Requires surgical debridement
    3. Is positive for β-hemolytic streptococci upon culture performed prior to screening debridement procedure
    4. Has > 50% slough, significant necrotic tissue, bone, tendon, or capsule exposure
    5. Is highly exuding (i.e., requires daily change of dressing)
  4. Requires total contact cast
  5. Ankle brachial pressure index < 0.7
  6. Has a local or systemic infection or local lymphangitis ≥ 0.5 cm
  7. Has any 1 of the following (only 1 of the 2 tests is required):

    1. 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
    2. Transcutaneous oxygen pressure (TcPO2) at the foot <40 mgHg
  8. Presence of active malignant or benign tumor of any kind, (with the exception to nonmelanoma skin cancer as per investigator's discretion)
  9. Congestive heart failure (New York Heart Association class II-IV)
  10. Coronary heart disease with ST segment elevation myocardial infarction or coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the last 6 months
  11. Active osteomyelitis of the foot with the target ulcer detected by x-ray, CT scan, or MRI
  12. Active connective tissue disease
  13. Acute or chronic Charcot's neuro-arthropathy as determined by clinical and/or radiographic examination
  14. 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)
  15. Active treatment with systemic antibiotics (wash out period for systemic antibiotics is 7 days for the inclusion in the study)
  16. Previous or current radiation therapy to the distal lower extremity or likelihood to receive this therapy during study participation
  17. Pregnant or nursing mothers
  18. Uncontrolled anemia (hemoglobin < 10 g/dL in females and < 12 g/dL in males)
  19. Estimated glomerular filtration rate < 25 mL/min
  20. Poor nutritional status, defined as an albumin < 25 g/L (< 2,500 mg/dl)
  21. Significant peripheral edema as per investigator's discretion
  22. Known inability or unavailability of a patient to complete required study visits during study participation
  23. 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
  24. Use of a platelet-derived growth factor within 28 days before screening
  25. Use of any investigational drug or therapy within 28 days before screening
  26. Has any other factor which may, in the opinion of the investigator, compromise participation and/or follow-up in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Hungary,   India,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02667327
Other Study ID Numbers  ICMJE 2015-DFU-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party FirstString Research, Inc.
Study Sponsor  ICMJE FirstString Research, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account FirstString Research, Inc.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP