EUCTR2019-001483-30-DK进行中（未招募）1 期
Effect of topical rhGM-CSF on the healing of venous leg ulcers: a randomized, placebo-controlled, double-blind, clinical phase II study - Repogel-01
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Men and women aged =18 years
- •2. 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.
- •3. 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.
- •4. 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
- •5. Ulcer duration =2 months and =3 years
- •6. Negative p-HCG for women of childbearing potential
- •7. Patient able to understand Danish
- •8. Patient able to comply with the protocol
- •9. Patient fully informed about the study and having given written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •1. Characteristics of the index ulcer:
- •a. Exposed bone, tendon, ligament, cartilage, joint or muscle
- •b. Cellulitis or clinical ulcer infection at the screening day D-4, or the day of randomization, D0.
- •c. Ulcers adjacent to the index ulcer that could interfere with the index ulcer, as judged by investigator
- •2. Patients that are unsuitable for the compression therapy used in the study
- •3. Known allergy towards GM-CSF, excipients or any other substances or remedies used in the trial.
- •4. Vascularization: Ankle-brachial index =0.7
- •5. Active or history of following diseases:
- •a. Cancer (past history of well-treated cancer is however accepted after a control period of more than two years).
- •b. Following autoimmune diseases: rheumatoid arthritis, autoimmune thrombocytopenia, thyroiditis, psoriasis, nephritis or multiple sclerosis.
- •c. Lower extremity deep venous thrombosis within the last 3 months
- •6. Any of following active diseases:
- •a. 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
- •b. Neutrophilic dermatoses (e.g. pyoderma gangrenosum and Sweet’s syndrome)
- •c. Severe renal-, hepatic or pulmonary insufficiency or severely dysregulated diabetes, as judged by investigator
- •d. 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).
- •e. Significant dementia
- •7. Biochemistry with clinically significant abnormalities that could preclude study participation as judged by the investigator, such as:
- •a. eGFR <20 mL/min/1.73 m2
- •b. Hb <5 mmol/L
- •c. ALAT >1.5 x upper limit of normal value
- •d. Albumin < 20 g/l
- •8. Prohibited therapy:
- •a. Systemic immunosuppressive treatment, immunomodulators, cytotoxic chemotherapy (exception: usage of corticosteroids) on D-4 or D0.
- •b. Corticosteroids with a daily dose equivalent to >10 mg of prednisolone per day on D-4 or D0.
- •c. Topical corticosteroids in the index ulcer bed or within 1 cm of the ulcer edge on D-4 or D0.
- •d. Biologics within 3 months of D-4 (anti-VEGF treatment in the eye in e.g. diabetics is however allowed).
- •9. Weight <50 kg or BMI >50
- •10. Participation in another clinical trial
- •11. Planned surgery or hospitalization during trial
- •12. Pregnant or lactating woman. Positive pregnancy test during run-in.
- •13. 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:
- •a. 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
- •b. 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.
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