Venous Leg UlcerPhase 1NCT02652572
Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Venous Leg Ulcers
A Phase 1 study testing Granexin in people with Venous Leg Ulcer, run by Xequel Bio, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to determine the systemic exposure of Granexin® gel after topical application to human subjects' venous leg ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Granexin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2015to May 2018
- Phase
- Phase 1
- 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
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 28Show fewer
- 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
- Platelet count < 100,000
- Presence of an active systemic or local cancer or tumor of any kind (with the exception of non-melanoma skin cancer)
- Patients with severe rheumatoid arthritis (with more than 20 persistently inflamed joints, or below lower normal limit blood albumin level, or evidence of bone and cartilage damage on x-ray, or inflammation in tissues other than joints) and other collagen vascular diseases.
- Patients with active connective tissue disease
- Treatment with systemic corticosteroids (>15 mg/day), or current immunosuppressive agents
- Previous or current radiation therapy or likelihood to receive this therapy during study participation
- Pregnant or nursing patients
- Known prior inability or unavailability to complete required study visits during study participation
- Significant peripheral edema as per investigator's discretion
- 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
3 sites in 1 country.
United States3 sites
Aiyan Diabetes Center
Augusta, Georgia, 30907
Salem VA Medical Center
Salem, Virginia, 24153
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, 29303
About this study
Official title: Open Label Pharmacokinetic Study of Granexin® Gel in Patients With Venous Leg Ulcers
The purpose of this study is to determine the systemic exposure of Granexin® gel after topical application to human subjects' venous leg ulcers.
Read the detailed description
The objective of this study is to ascertain the systemic exposure of the active ingredient in Granexin® gel (aCT1 peptide) after topical application to venous leg ulcers using pharmacokinetic analysis. It is planned that a total of 16 patients with venous leg ulcers will receive Granexin® gel treatment plus standard of care in this one arm study. The study includes a screening period (1 week) and a treatment period (1 week) which occur sequentially for a given patient.The baseline day, which demarcates the beginning of the treatment period, is the designated as Day 0. Screening procedures are initially conducted on Day -7.
A target venous leg ulcer is identified at screening and patient eligibility is confirmed at screening and then again at the beginning of the Day 0 (baseline) visit. A patient enrolled in the study may have multiple ulcers on the same or either leg; in this case, all ulcers will be treated with Granexin® gel, but only ulcer(s) meeting the following criteria will be designated as the target ulcer(s) and will determine eligibility: >15cm2 of least 4 weeks duration in post debridement.
The treatment period for a given patient begins on Day 0 and ends one week later; the last scheduled day of the treatment period is designated as Day 7. During each treatment period, each patient is scheduled to receive topical treatment with study drug gel (3 applications total) administered by study staff at scheduled study site visits at each of the following time points: Day 0 , Day 3, and Day 7. All patients, regardless of treatment assignment, also receive standard-of-care treatment at scheduled study visits during the treatment period.
Study drug pre-application blood samples will be collected from each patient at Day 0, Day 3, and Day 7. Study drug post-application blood samples will be collected at Day 0 and Day 7 at time points specified in the protocol. These blood samples will be shipped to a designated laboratory for pharmacokinetic analysis.
Safety will be assessed during the treatment period by monitoring adverse events, measuring vital signs at each visit, performing physical examinations, electrocardiograms (ECG), as well as pharmacokinetic (PK) blood analysis.
- Conditions
- Venous Leg Ulcer
- Being tested
- Granexin
- Keywords
- Granexin, venous leg ulcer, pharmacokinetic study, FirstString Research
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GranexinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Granexin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of aCT1 peptide (Active Pharmaceutical Ingredient in Granexin) levels in blood
Measured: Day 0
Measurement of aCT1 peptide (Active Pharmaceutical Ingredient in Granexin) levels in blood
Measured: Day 3
Measurement of aCT1 peptide (Active Pharmaceutical Ingredient in Granexin) levels in blood
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xequel Bio, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Spartanburg Regional Healthcare System, Medical University of South Carolina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652572
- Sponsor's protocol ID
- VLU-PK-300
- Status last verified
- Jul 2018
- First submitted
- 8 Jan 2016
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Pharmacokinetic Study of Granexin® Gel in Patients With Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT02652572
- Acronym / sponsor ID
- VLU-PK-300
- Conditions
- Venous Leg Ulcer
- Keywords
- Granexin, venous leg ulcer, pharmacokinetic study, FirstString Research
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Xequel Bio, Inc.University, hospital or other
- Collaborators
- Spartanburg Regional Healthcare System, Medical University of South Carolina
- Study start
- Sep 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 12 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 the systemic exposure of Granexin® gel after topical application to human subjects' venous leg ulcers.
Detailed description
The objective of this study is to ascertain the systemic exposure of the active ingredient in Granexin® gel (aCT1 peptide) after topical application to venous leg ulcers using pharmacokinetic analysis. It is planned that a total of 16 patients with venous leg ulcers will receive Granexin® gel treatment plus standard of care in this one arm study. The study includes a screening period (1 week) and a treatment period (1 week) which occur sequentially for a given patient.The baseline day, which demarcates the beginning of the treatment period, is the designated as Day 0. Screening procedures are initially conducted on Day -7.
A target venous leg ulcer is identified at screening and patient eligibility is confirmed at screening and then again at the beginning of the Day 0 (baseline) visit. A patient enrolled in the study may have multiple ulcers on the same or either leg; in this case, all ulcers will be treated with Granexin® gel, but only ulcer(s) meeting the following criteria will be designated as the target ulcer(s) and will determine eligibility: >15cm2 of least 4 weeks duration in post debridement.
The treatment period for a given patient begins on Day 0 and ends one week later; the last scheduled day of the treatment period is designated as Day 7. During each treatment period, each patient is scheduled to receive topical treatment with study drug gel (3 applications total) administered by study staff at scheduled study site visits at each of the following time points: Day 0 , Day 3, and Day 7. All patients, regardless of treatment assignment, also receive standard-of-care treatment at scheduled study visits during the treatment period.
Study drug pre-application blood samples will be collected from each patient at Day 0, Day 3, and Day 7. Study drug post-application blood samples will be collected at Day 0 and Day 7 at time points specified in the protocol. These blood samples will be shipped to a designated laboratory for pharmacokinetic analysis.
Safety will be assessed during the treatment period by monitoring adverse events, measuring vital signs at each visit, performing physical examinations, electrocardiograms (ECG), as well as pharmacokinetic (PK) blood analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Granexin® gel plus standard-of-care | Experimental | Drug: GranexinGranexin® 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (28 listed)
- 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
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 |
|---|---|---|
| GranexinGranexin® 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. | Drug | Granexin® gel plus standard-of-care |
Primary outcome
Measurement of aCT1 peptide (Active Pharmaceutical Ingredient in Granexin) levels in blood
Time frame: Day 0
Measurement of aCT1 peptide (Active Pharmaceutical Ingredient in Granexin) levels in blood
Time frame: Day 3
Measurement of aCT1 peptide (Active Pharmaceutical Ingredient in Granexin) levels in blood
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Granexin in people with Venous Leg Ulcer, run by Xequel Bio, Inc. at 3 sites in United States.
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 10 inclusion and 28 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: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of aCT1 peptide (Active Pharmaceutical Ingredient in Granexin) levels in blood (time frame: Day 0). The study lists 3 primary outcomes in all. 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 1 Aug 2018.