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.
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.
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
Apparently healthy volunteers
Cohort
Prospective
Not listed
Percentage of subjects with static stiffness index SSI ≥ 10 mmHg over the course of 7 days
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.
Percentage of subjects with resting pressures higher than 20 mmHg and 40 mmHg up to day 7
The resting pressures are obtained during muscle relaxation or rest when the participant is lying.
Rate of participants assessing the wearing comfort on a 6-level scale.
Participants will be asked on their experience on the wearing comfort like mobility of the ankle and slippage or sensations like heat, sweating or pain.
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