Status:
UNKNOWN
Effect of rhGM-CSF on the Healing of Venous Leg Ulcers
Lead Sponsor:
Reponex Pharmaceuticals A/S
Conditions:
Venous Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 w...
Eligibility Criteria
Inclusion
- 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
- Patient able to understand Danish
- Patient able to comply with the protocol
- Patient fully informed about the study and having given written informed consent
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
March 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04823962
Start Date
March 11 2021
End Date
December 30 2023
Last Update
November 17 2022
Active Locations (1)
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1
Department of Dermatology and Copenhagen Wound Healing Center, Bispebjerg Hospital
Copenhagen, Denmark