NCT04902651终止不适用
A PROSPECTIVE, CONTROLLED, RANDOMIZED, OPEN-LABEL PREMARKET MULTICENTER STUDY OF THE PERFORMANCE OF THE HM242-GEL VS COMPARATOR IN PATIENTS UNDER THE CONDITION OF VENOUS LEG ULCER
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 73
- 试验地点
- 6
- 主要终点
- The primary objective of the study is to demonstrate that the HM242-Gel performs at least comparably to INTRASITE Gel with regard to wound healing.
研究概览
简要总结
The primary objective of the study is to demonstrate that the HM242-Gel performs at least comparably to INTRASITE Gel with regard to wound healing.
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
- None
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
- •Males or females of at least 18 years at the time of enrolment
- •The legal capacity and ability to understand the nature, risks, significance and scope of the clinical trial and to determine his or her will accordingly
- •Signed form of consent, including the understanding of and willingness by the patient to participate in the clinical study and ability to comply with study procedures and study visit schedule
- •Patients must be willing to have all dressing changes performed by the wound specialist, with no treatments at home
- •Presence of at least one venous ulcer of the lower leg extending through the full thickness of the skin but not down to muscle, tendon or bone
- •Size of study ulcer ≥ 2cm² and ≤ 100cm² measured using the tracing method.
- •Presence of venous leg ulcer for at least 6 weeks, but not longer than 12 months
- •Ankle Brachial Pressure Index (ABI) > 0.75
- •In the case of a female patient of childbearing potential, willingness to use highly effective methods of contraception (failure rate of < 1% when used consistently and correctly);acceptable contraceptive measures in this trial are: combined pill and progestin-only pill, contraceptive patch, ring or injection, Etonogestrel implant, intrauterine device (IUD) (copper and Levonogestrel), male sterilization (vasectomy), female sterilization (abdominal, laparoscopic, hysteroscopic), or sexual abstinence.
排除标准
- •Patients kept in an institution due to an official or court order
- •Patients dependent on the Sponsor, Investigator or Site
- •Patients suspected of having SARS-CoV-2 infection or COVID-19 disease
- •Study ulcer judged by the Investigator to be caused by a medical condition other than venous insufficiency
- •Study ulcer with signs and symptoms of infection, or under suspicion of cancer
- •Study ulcer under treatment with topical antimicrobials within past two weeks or systemic antimicrobial treatment within past two weeks
- •In the case of heavily exuding ulcers, if in the opinion of Investigator the patient is not suitable for treatment with gel
- •More than two venous leg ulcers or more than two chronic wounds
- •Dementia stage greater than 3 according to Reisberg
- •Known allergies against wound dressings used in the study
- •Known chronical skin diseases, dermatoses, or known allergies or other conditions which might trigger dermatitis
- •Acute cases of substance use disorders (ICD-10 F1x.1 or F1x.2)
- •Buerger's disease
- •Participation in Medical Device trials less than 4 weeks ago or participation in Drug trials less than six months ago
- •Terminally ill patients
- •Patients with poorly managed diabetes mellitus: absence of a glycated hemoglobin test within the last 3 months or a result of HbA1c ≥ 8% not older than 3 months, or a major diabetes-related incident within the past 4 weeks
- •Ulcers of diabetic origin
- •Patients under treatment with systemic corticosteroids, immunosuppressant, cytotoxic chemotherapy, or radiotherapy
- •Presence of one or more medical conditions (other than venous insufficiency and diabetes) as determined by medical history, which:
- •Is known to interfere with the wound healing process (e.g. arteriopathy, vasculitis, rheumatoid arthritis, systemic lupus erythematosus, other auto-immune diseases, cancer, immunodeficiency, severe lymphedema of the leg, thrombophilia)
- •In the opinion of the Investigator, would make the patient an inappropriate candidate for this venous ulcer healing study (e.g. malnutrition, hygiene, obesity)
- •Pregnant or lactating patients
结局指标
主要结局
The primary objective of the study is to demonstrate that the HM242-Gel performs at least comparably to INTRASITE Gel with regard to wound healing.
时间窗: 28 days
The primary variable is defined as the relative reduction of the wound area of a patient in percentage 28 days (4 weeks) after baseline. The wound size area is measured on site by the tracing method.
次要结局
未报告次要终点
研究者
研究点 (6)
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