Venous Leg UlcerPhase 2NCT04823962
Effect of rhGM-CSF on the Healing of Venous Leg Ulcers
A Phase 2 study testing rhGM-CSF + hydrogel in people with Venous Leg Ulcer, run by Reponex Pharmaceuticals A/S at 1 site in Denmark.
Trial summary
The objective of this study is to examine whether local administration of the growth factor rhGM-CSF incorporated into a hydrogel, can accelerate wound healing when applied to venous leg ulcers, and whether this is safe. 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?
- rhGM-CSF + hydrogel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Mar 2021to 30 Dec 2023
- Phase
- Phase 2
- 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
- Men and women aged aged 18 years or older
- Patients with at least one difficult-to-heal venous leg ulcer on standard care (diagnosed by clinical evaluation) localized between the knee and ankle, including the perimalleolar area.
- Venous insufficiency confirmed by a venous Doppler/duplex ultrasound scan. A previous scan before randomization can be used. If there is no previous adequate scanning, a new scanning has to be performed before randomization.
- Ulcer size 2-75 cm2 at randomization day (D0), the upper limit being defined as the largest ulcer in size that fits the area selection criteria
- Ulcer duration ≥2 months and ≤3 years
- Negative p-HCG for women of childbearing potential
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- Patient able to understand Danish
- Patient able to comply with the protocol
- Patient fully informed about the study and having given written informed consent
Who cannot join
- Characteristics of the index ulcer:
- Exposed bone, tendon, ligament, cartilage, joint or muscle
- Cellulitis or clinical ulcer infection at the screening day D-4, or the day of randomization, D0.
- Ulcers adjacent to the index ulcer that could interfere with the index ulcer, as judged by investigator
- Patients that are unsuitable for the compression therapy used in the study
- Known allergy towards GM-CSF, excipients or any other substances or remedies used in the trial.
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- Vascularization: Ankle-brachial index ≤0.7
- Active or history of following diseases:
- Cancer (past history of well-treated cancer is however accepted after a control period of more than two years).
- Following autoimmune diseases: rheumatoid arthritis, autoimmune thrombocytopenia, thyroiditis, psoriasis, nephritis or multiple sclerosis.
- Lower extremity deep venous thrombosis within the last 3 months
- Any of following active diseases:
- Serious heart disease, including unstable angina pectoris, a major cardiac event such as myocardial infarction, congestive heart failure NYHA class III-IV within 3 months before the study
- Neutrophilic dermatoses (e.g. pyoderma gangrenosum and Sweet's syndrome)
- Severe renal-, hepatic or pulmonary insufficiency or severely dysregulated diabetes, as judged by investigator
- Myeloproliferative diseases and hematologic diseases (e.g. myelodysplastic syndrome and leukemia). Anemia due to chronic infection or due to deficiency of iron, B12 or folic acid is accepted if Hb >5 mmol/L).
- Significant dementia
- Biochemistry with clinically significant abnormalities that could preclude study participation as judged by the investigator, such as:
- eGFR <20 mL/min/1.73 m2
- Hb <5 mmol/L
- ALAT >1.5 x upper limit of normal value
- Albumin < 20 g/l
- Prohibited therapy:
- Systemic immunosuppressive treatment, immunomodulators, cytotoxic chemotherapy (exception: usage of corticosteroids) on D-4 or D0.
- Corticosteroids with a daily dose equivalent to >10 mg of prednisolone per day on D-4 or D0.
- Topical corticosteroids in the index ulcer bed or within 1 cm of the ulcer edge on D-4 or D0.
- Biologics within 3 months of D-4 (anti-VEGF treatment in the eye in e.g. diabetics is however allowed).
- Weight <50 kg or BMI >50
- Participation in another clinical trial
- Planned surgery or hospitalization during trial
- Pregnant or lactating woman. Positive pregnancy test during run-in.
- Failure to agree to using an adequate method of contraception (having a failure rate of < 1% per year) throughout the study period for heterosexually active males and females of childbearing potential, or disagreement to remain abstinent (refrain from heterosexual intercourse). A woman is considered to be of childbearing potential if she is post-menarche and:
- Has not reached a postmenopausal state (≥60 years of age and amenorrhea for at least ≥12 months with no identified cause other than menopause, and has not undergone surgical sterilization: removal of ovaries and/or uterus) - OR
- No menses for over a year and confirmed by follicle-stimulating hormone (FSH) levels elevated into the postmenopausal range Examples of contraceptive methods with a failure rate of <1% per year includes bilateral tubal ligation, male sterilization, proper use of hormonal contraceptives, hormone-releasing intrauterine devices and copper intrauterine devices. Male participants must be abstinent or use a condom during the trial period.
- Blood or sperm donation during trial
- Patient has previously been randomized in this study (rescreening is accepted otherwise)
- Judgment by the investigator that the patient is not suited for study participation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital
Copenhagen
About this study
Official title: Effect of Topical rhGM-CSF on the Healing of Venous Leg Ulcers: a Randomized, Placebo-controlled, Double-blind, Clinical Phase II Study
The objective of this study is to examine whether local administration of the growth factor rhGM-CSF incorporated into a hydrogel, can accelerate wound healing when applied to venous leg ulcers, and whether this is safe.
- Conditions
- Venous Leg Ulcer
- Being tested
- rhGM-CSF + hydrogel, Placebo hydrogel, Standard care
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhGM-CSF + hydrogelDrug
Also called Repogel, Molgramostim
The active substance: molgramostim (rhGM-CSF)
Placebo hydrogelDrug
Placebo hydrogel
Standard careOther
Compression therapy and neutral dressings
| Study group | Role | What they receive |
|---|---|---|
| GM-CSF | Experimental | rhGM-CSF (molgramostim) + hydrogel Receives: Drug: rhGM-CSF + hydrogel; Other: Standard care |
| Placebo | Placebo comparator | Hydrogel Receives: Drug: Placebo hydrogel; Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reaching a 40% ulcer area reduction, or more, 4 weeks after initiation of the study drug treatment/placebo
Ulcer size (area in cm2) will be assessed on the randomization day (Day 0; initiation of the study drug treatment/placebo) and at the end of the study drug/placebo treatment (D28+1)
Measured: 4 weeks after initiation of the study drug treatment/placebo
Secondary outcomes (6)
Absolute change of the ulcer area
The ulcer size is compared in terms of change in cm2 from the randomization day
Measured: 4 and 8 weeks after randomization
Percentage change of the ulcer area
The ulcer size is compared in terms of percentage change from the randomization day
Measured: 4 and 8 weeks after randomization
Complete ulcer healing
Number of subjects reaching complete ulcer healing; Full epithelization and no drainage of wound fluid or dressing requirements
Measured: 4 and 8 weeks after randomization
Time to complete ulcer healing
Time to complete ulcer healing in days, with the randomization day as baseline
Measured: Through study completion (8 weeks)
Clinical improvement of the wound healing process
Semi-quantitatively measured (major improvement, minor improvement, status quo or worsening)
Measured: 4 and 8 weeks after randomization
Assessment of the safety profile
All clinical and laboratory adverse events will be assessed and recorded.
Measured: Throughout the trial (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start11 Mar 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, placebo-controlled and double-blind, phase II clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reponex Pharmaceuticals A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Torsten Bjørn, Reponex Pharmaceuticals A/S
- Investigators
- Ewa A Burian, MD, Principal investigator, Department of Dermatology and Copenhagen Wound Healing Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823962
- Sponsor's protocol ID
- Repogel-01
- Status last verified
- Nov 2022
- First submitted
- 6 Mar 2021
- Last updated
- 17 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical rhGM-CSF on the Healing of Venous Leg Ulcers: a Randomized, Placebo-controlled, Double-blind, Clinical Phase II Study
- ClinicalTrials.gov ID
- NCT04823962
- Acronym / sponsor ID
- Repogel-01
- Conditions
- Venous Leg Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Reponex Pharmaceuticals A/SIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 1 Apr 2021 (actual)
- 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 objective of this study is to examine whether local administration of the growth factor rhGM-CSF incorporated into a hydrogel, can accelerate wound healing when applied to venous leg ulcers, and whether this is safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, placebo-controlled and double-blind, phase II clinical trial
| Arm | Type | Receives |
|---|---|---|
| GM-CSF | Experimental | Drug: rhGM-CSF + hydrogel, Other: Standard carerhGM-CSF (molgramostim) + hydrogel |
| Placebo | Placebo comparator | Drug: Placebo hydrogel, Other: Standard careHydrogel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women aged aged 18 years or older
- Patients with at least one difficult-to-heal venous leg ulcer on standard care (diagnosed by clinical evaluation) localized between the knee and ankle, including the perimalleolar area.
- Venous insufficiency confirmed by a venous Doppler/duplex ultrasound scan. A previous scan before randomization can be used. If there is no previous adequate scanning, a new scanning has to be performed before randomization.
- Ulcer size 2-75 cm2 at randomization day (D0), the upper limit being defined as the largest ulcer in size that fits the area selection criteria
- Ulcer duration ≥2 months and ≤3 years
Key exclusion criteria (37 listed)
- Characteristics of the index ulcer:
- Patients that are unsuitable for the compression therapy used in the study
- Known allergy towards GM-CSF, excipients or any other substances or remedies used in the trial.
- Vascularization: Ankle-brachial index ≤0.7
- Active or history of following diseases:
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 |
|---|---|---|
| rhGM-CSF + hydrogelAlso: Repogel, MolgramostimThe active substance: molgramostim (rhGM-CSF) | Drug | GM-CSF |
| Placebo hydrogelPlacebo hydrogel | Drug | Placebo |
| Standard careCompression therapy and neutral dressings | Other | GM-CSF, Placebo |
Primary outcome
Proportion of patients reaching a 40% ulcer area reduction, or more, 4 weeks after initiation of the study drug treatment/placebo
Time frame: 4 weeks after initiation of the study drug treatment/placebo
Ulcer size (area in cm2) will be assessed on the randomization day (Day 0; initiation of the study drug treatment/placebo) and at the end of the study drug/placebo treatment (D28+1)
6 secondary outcomes
Absolute change of the ulcer area
Time frame: 4 and 8 weeks after randomization
Percentage change of the ulcer area
Time frame: 4 and 8 weeks after randomization
Complete ulcer healing
Time frame: 4 and 8 weeks after randomization
Time to complete ulcer healing
Time frame: Through study completion (8 weeks)
Clinical improvement of the wound healing process
Time frame: 4 and 8 weeks after randomization
Assessment of the safety profile
Time frame: Throughout the trial (8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Ewa A Burian, MD principal investigator
Department of Dermatology and Copenhagen Wound Healing Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rhGM-CSF + hydrogel in people with Venous Leg Ulcer, run by Reponex Pharmaceuticals A/S at 1 site in Denmark.
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 9 inclusion and 37 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: status not confirmed, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Proportion of patients reaching a 40% ulcer area reduction, or more, 4 weeks after initiation of the study drug treatment/placebo (time frame: 4 weeks after initiation of the study drug treatment/placebo). 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 17 Nov 2022.