2023-05 Rosidal® 1C Pilot Study. Prospective, Mono-centric, Observational Randomized Controlled Study in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Percentage of subjects with static stiffness index SSI ≥ 10 mmHg over the course of 7 days
研究概览
简要总结
The goal of this study is to learn about the pressure that can be maintained by a new compression bandage over the course of seven days in healthy volunteers. This bandage combines skin protection, padding and compression in one single bandage. It will be applied to the participants lower legs. A similar device will be applied to the other lower leg of the participant. A randomisation method is used for the assignment of the bandages to the participants legs.
Researchers will compare the bandage pressures of both bandages. The so-called sub-bandage pressure will be measured at the day of application and on the next day, the third day and the last day. Participants will also be asked about the wearing comfort of both bandages.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy intact skin with no clinical signs of chronic venous insufficiency and no signs of any dermatological condition such as eczema or psoriasis as assessed by investigating physician.
- •Ankle circumference > 18 cm (2 cm above ankle) as assessed by the investigating physician.
排除标准
- •Known sensitivity to the study products (Rosidal 1C or Urgo K1) or any of their components
- •Chronic venous disease with CEAP ≥2
- •Ankle Brachial Pressure Index (ABPI) < 0.8 or >1.3
- •Ankle circumference <18 or > 32 cm
- •Venous echo-Doppler with recognizable abnormalities
- •History of
- •malignant ulcer
- •clinically infected wound
- •peripheral arterial occlusive diseases,
- •cardiac insufficiency or cardiac disease such as congestive heart failure, coronary artery disease, myocardial infarction, coronary artery bypass graft
- •cerebrovascular disease
- •liver or renal disease
- •septic phlebitis,
- •phlegmasia coerulea dolens,
- •sensation disorders of the skin
- •eczema, psoriasis
- •Use of diuretics, antihypertension or drugs that influence the capillary infiltration
- •Comorbidities that could affect compression therapy, particularly diseases causing oedema
- •Reliable severe malnutrition
- •Diabetes Mellitus
- •BMI > 30 kg/m2
- •Pregnancy or breast feeding
- •Participation in an interventional clinical trial within the last 3 months and during participation in this study
- •Participant is analphabet
研究组 & 干预措施
Healthy Volunteers
结局指标
主要结局
Percentage of subjects with static stiffness index SSI ≥ 10 mmHg over the course of 7 days
时间窗: Day 0, 1, 3, 7
The pressure is measured underneath the compression bandage ("sub-bandage pressure") which is applied onto the lower leg. A pressure sensor is positioned in between the skin and the compression bandage. The static stiffness index is the pressure difference between active standing and lying.
Static Stiffness Index SSI
时间窗: Day 0
The static stiffness index is the sub-bandge pressure difference between active standing and lying.
次要结局
- Percentage of subjects with resting pressures higher than 20 mmHg and 40 mmHg up to day 7(Day 0, 1, 3, 7)
- Rate of participants assessing the wearing comfort on a 6-level scale.(Day 0, 1, 7)
- Sub-bandage Resting Pressure After One Week of Contionous Wearing of the Comprression Bandages(Day 0 + 6 days)
- Number of Participants Assessing the Wearing Comfort by Ankle Mobility as Acceptable or Better(Day 0 + 6 days)