NCT04823962进行中（未招募）2 期
Effect of Topical rhGM-CSF on the Healing of Venous Leg Ulcers: a Randomized, Placebo-controlled, Double-blind, Clinical Phase II Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Proportion of patients reaching a 40% ulcer area reduction, or more, 4 weeks after initiation of the study drug treatment/placebo
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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, D
- •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 D
- •Corticosteroids with a daily dose equivalent to >10 mg of prednisolone per day on D-4 or D
- •Topical corticosteroids in the index ulcer bed or within 1 cm of the ulcer edge on D-4 or D
- •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
研究组 & 干预措施
GM-CSF
Experimental
rhGM-CSF (molgramostim) + hydrogel
干预措施: rhGM-CSF + hydrogel (Drug)
GM-CSF
Experimental
rhGM-CSF (molgramostim) + hydrogel
干预措施: Standard care (Other)
Placebo
Placebo Comparator
Hydrogel
干预措施: Placebo hydrogel (Drug)
Placebo
Placebo Comparator
Hydrogel
干预措施: Standard care (Other)
结局指标
主要结局
Proportion of patients reaching a 40% ulcer area reduction, or more, 4 weeks after initiation of the study drug treatment/placebo
时间窗: 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)
次要结局
- Absolute change of the ulcer area(4 and 8 weeks after randomization)
- Percentage change of the ulcer area(4 and 8 weeks after randomization)
- Complete ulcer healing(4 and 8 weeks after randomization)
- Time to complete ulcer healing(Through study completion (8 weeks))
- Clinical improvement of the wound healing process(4 and 8 weeks after randomization)
- Assessment of the safety profile(Throughout the trial (8 weeks))
研究者
Torsten Bjørn
Prinicipal Investigator, MD
Reponex Pharmaceuticals A/S
研究点 (1)
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