Actively Recruiting
Investigation of a New Compression Bandage System Combining Skin Protection, Padding and Compression in One Single Bandage and Comparing to an Existing One-component Bandage.
Led by Lohmann & Rauscher · Updated on 2025-01-13
25
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigation of a New Compression Bandage System Combining Skin Protection, Padding and Compression in One Single Bandage and Comparing to an Existing One-component Bandage.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy intact skin with no signs of chronic venous insufficiency or dermatological conditions such as eczema or psoriasis as assessed by the investigating physician
- Ankle circumference greater than 18 cm (measured 2 cm above the ankle) as assessed by the investigating physician
You will not qualify if you...
- Known sensitivity to the study products (Rosidal 1C or Urgo K1) or any of their components
- Chronic venous disease with CEAP stage 2 or higher
- Ankle Brachial Pressure Index (ABPI) less than 0.8 or greater than 1.3
- Ankle circumference less than 18 cm or greater than 32 cm
- Venous echo-Doppler showing 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, or psoriasis
- Use of diuretics, antihypertension drugs, or drugs influencing capillary infiltration
- Comorbidities affecting compression therapy, especially diseases causing edema
- Severe malnutrition
- Diabetes Mellitus
- Body Mass Index (BMI) over 30 kg/m2
- Pregnancy or breastfeeding
- Participation in an interventional clinical trial within the last 3 months or during this study
- Participant is illiterate
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Clinical and Experimental Medicine, University of Pisa, UOC Dermatologia Universitaria, Santa Chiara Hospital AOUP
Pisa, Italy, 56126
Actively Recruiting
Research Team
C
Christine Boehm, MD PhD
CONTACT
M
Martin Abel, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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