Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0, 1, 3, 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0, 1, 3, 7 |
| Rate of participants assessing the wearing comfort on a 6-level scale. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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
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
Not provided
Not provided
Not provided
Apparently healthy volunteers
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Boehm, MD PhD | Contact | +49 2634 996144 | Christine.Boehm@de.LRmed.com | |
| Martin Abel, PhD | Contact | +49 2631 996566 | Martin.Abel@de.LRmed.com |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. Valentina Dini | Department of Clinical and Experimental Medicine, University of Pisa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical and Experimental Medicine, University of Pisa, UOC Dermatologia Universitaria, Santa Chiara Hospital AOUP | Recruiting | Pisa | 56126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41528788 | Derived | Dini V, Vietina A, Michelucci A, Rizzello F, Romanelli M, Mosti G, Namislo A, Bohm C, Abel M. A prospective, monocentric, observational randomised controlled pilot study of two all-in-one multicomponent compression systems in healthy volunteers. J Wound Care. 2026 Jan 2;35(1):26-34. doi: 10.12968/jowc.2025.0456. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 26, 2026 | |
| Reset | Mar 18, 2026 | |
| Release | Mar 19, 2026 |
Not provided
Not provided
Not provided
Not provided
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. |
| Day 0, 1, 7 |
| Reset | Apr 7, 2026 |
| Release | Apr 9, 2026 |
| Reset | Apr 29, 2026 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 26, 2026 | Mar 18, 2026 | |||
| Mar 19, 2026 | Apr 7, 2026 | |||
| Apr 9, 2026 | Apr 29, 2026 |