Can a single bandage keep steady pressure for a week?
NCT ID NCT06728137
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This pilot study tests a new compression bandage that combines skin protection, padding, and compression in one layer. Healthy volunteers wear the bandage on one lower leg and a similar standard bandage on the other for seven days. Researchers measure the pressure under each bandage at several points and ask participants about comfort. The goal is to see if the new bandage maintains consistent pressure over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A new compression bandage that combines skin protection, padding, and compression in one, compared to a similar standard bandage
- What this could lead to
- If the new bandage holds steady pressure and feels comfortable, it could offer a simpler, more effective option for managing leg swelling and venous conditions in future patients.
- What could go wrong
- This is a small pilot study in healthy volunteers, so results may not apply to people with medical conditions. The bandage might not maintain pressure as well as expected or could cause discomfort.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
-
22 people
The number who actually took part.
- Started
-
Jan 2025
- Finished
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Apr 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Apparently healthy volunteers
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. 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 * 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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Department of Clinical and Experimental Medicine, University of Pisa, UOC Dermatologia Universitaria, Santa Chiara Hospital AOUP
Pisa, 56126, Italy
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