NCT06584617招募中不适用
A Prospective, 8-week, Multi-centre, Randomised, Open-label Clinical Investigation Comparing Clinical Efficacy and Safety of Berovenal® with a Reference Amorphous Hydrogel in Subjects with Shallow, Non-infected, Chronic Diabetic Foot Ulcer
VULM s.r.o.18 个研究点 分布在 2 个国家目标入组 66 人开始时间: 2023年5月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 18
- 主要终点
- Evaluation of clinical efficacy based on comparison of the percentage reduction in Index ulcer area.
研究概览
简要总结
The goal of this clinical investigation is to evaluate clinical efficacy of medical device Berovenal® intended to promote treatment and to expedite healing of chronic diabetic foot ulcer in male or female subjects aged 18-85 years with diabetes mellitus (type 1 or 2) and with present diabetic foot ulcer by providing moist environment similar to intracellular environment of the damaged tissue. It will also learn about the safety of medical device Berovenal®.
The main questions it aims to answer are:
- Does medical device Berovenal® lower the size of diabetic foot ulcer?
- What medical problems do participants have when using medical device Berovenal®?
Researchers will compare medical device Berovenal® to a reference device (device with similar purpose of use).
Participants will:
- Use medical device Berovenal® or a reference device every day for 8 weeks or to the time point when the diabetic foot is closed
- Visit the clinic once every 2 weeks for checkups and tests
- Keep a diary of their symptoms and the number of times they use medical device Berovenal® or a reference device
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male, or female subjects aged 18-85 years;
- •diabetes mellitus (type 1 or 2) documented at least 12 months prior to Visit 1;
- •presence of a diabetic foot ulcer meeting the following criteria (Index ulcer):
- •grade 1 or 2 according to the Wagner classification;
- •if applicable, surgically debrided ≥ 7 days prior to Visit 1;
- •at the time of randomisation:
- •sized 1 - 25 cm2;
- •present for ≥ 14 days;
- •offloaded for ≥ 7 days;
- •not infected.
- •HbA1c ≤ 10% (DCCT) or 85.8 mmol/mol (IFCC) at Visit 1;
- •willing and able to comply with the scheduled procedures;
- •legally capable, able to understand the provided information and willing to sign the informed consent form.
排除标准
- •known contraindication for application of hydrogel dressings, incl. Berovenal® and NU-GEL Hydrogel with Alginate;
- •at the time of randomisation - documented reduction in Index ulcer area by > 20%, as compared to its size at Visit 1;
- •Index ulcer primarily caused by a medical condition other than diabetes mellitus;
- •inadequate arterial circulation to the foot documented within 28 days prior to Visit 1, or during the screening period:
- •Ankle-brachial Index < 0.7 or > 1.3 and/or
- •Toe-brachial Index < 0.7;
- •presence of acute Charcot's neuro-arthropathy, or osteomyelitis, on the affected foot within 3 months prior to Visit 1;
- •use of wound dressings that include growth factors, bioengineered tissues, or skin substitutes within 14 days prior to Visit 1, or documented intention to use them during the subject's participation;
- •use of any investigational drug(s) or device(s), systemic immunosuppressive treatment (including systemic corticosteroids), or application of topical steroids to the Index ulcer surface, within 28 days prior to Visit 1;
- •use of cytotoxic chemotherapy and/or radiotherapy within 6 months prior to Visit 1;
- •known history of bone cancer or metastatic disease of the affected limb;
- •poor nutritional status;
- •presence of an on-going uncontrolled renal, hepatic, cardiovascular or other disease that could pose an additional risk for the participant, or could significantly influence interpretation of the results (as evaluated by the investigator);
- •known history of non-compliance and/or presence of any condition(s) seriously compromising the subject's ability to adhere to the procedures required by this Clinical Investigational Plan;
- •pregnant or breast-feeding females;
- •females of childbearing potential not using an effective method of contraception.
结局指标
主要结局
Evaluation of clinical efficacy based on comparison of the percentage reduction in Index ulcer area.
时间窗: 8 weeks
次要结局
- Evaluation of clinical efficacy based on improvement in the subject's reported quality of life assessed by the Wound-QoL(2, 4, 6 and 8 weeks)
- Evaluation of safety based on proportion of target wounds with a documented wound infection(8 weeks)
- Evaluation of clinical efficacy based on proportion of subjects who achieved complete closure of Index ulcers(8 weeks)
- Evaluation of clinical efficacy based on median time until complete Index ulcer closure(8 weeks)
- Evaluation of clinical efficacy based on mean percentage change of the Index ulcer area(2, 4, 6 and 8 weeks)
- Evaluation of clinical efficacy based on wound healing process(2, 4, 6 and 8 weeks)
- Evaluation of clinical efficacy based on proportion of subjects who achieved a reduction in the Index ulcer area by ≥ 80%(4, 6 and 8 weeks)
- Evaluation of safety occurrence of adverse events, device failures or complaints(8 weeks)
研究者
研究点 (18)
Loading locations...
相似试验
已完成
不适用
Study to Evaluate the Iovera° Device for Temporary Relief From Knee PainKnee OsteoarthritisNCT02260921Pacira Pharmaceuticals, Inc180
已完成
不适用
Endovenous Radiofrequency Ablation Closure System in the Treatment of Varicose VeinsVaricose VeinsNCT04671641Suzhou Hengruihongyuan Medical Technology Co. LTD176
已完成
不适用
Treatment of Actinic Keratosis With 5% KOH SolutionActinic KeratosesNCT04024579Infectopharm Arzneimittel GmbH73
终止
2 期
Study of Occipital Nerve Stimulation for Drug Refractory MigraineMigraineNCT00747812Boston Scientific Corporation11
已完成
不适用
Prospective Study Evaluating the Treatment of Hyperdynamic Forehead WrinklesWrinklesNCT01984619Pacira Pharmaceuticals, Inc47