Department of Clinical and Experimental Medicine, University of Pisa, UOC Dermatologia Universitaria, Santa Chiara Hospital AOUP
Pisa, 56126, Italy
Location status: Recruiting
NCT Number: NCT06728137
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Pisa, 56126, Italy
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: Day 0, 1, 3, 7
The resting pressures are obtained during muscle relaxation or rest when the participant is lying.
Time frame: Day 0, 1, 7
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.
Contact information is provided by the study sponsor or research team.
Christine Boehm, MD PhD
CONTACT
Martin Abel, PhD
CONTACT
Lohmann & Rauscher
Industry
2023-05 Rosidal® 1C Pilot Study. Prospective, Mono-centric, Observational Randomized Controlled Study in Healthy Volunteers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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