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.

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical and Experimental Medicine, University of Pisa, UOC Dermatologia Universitaria, Santa Chiara Hospital AOUP

Pisa, 56126, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Static Stiffness Index SSI

Time frame: Day 0

The static stiffness index is the sub-bandge pressure difference between active standing and lying.

Secondary outcomes

Sub-bandage Resting Pressure After One Week of Contionous Wearing of the Comprression Bandages

Time frame: Day 0 + 6 days

The sub-bandage resting pressures are measured during muscle relaxation or rest when the participant is lying.
Number of Participants Assessing the Wearing Comfort by Ankle Mobility as Acceptable or Better

Time frame: Day 0 + 6 days

Participants were asked on the last day how they rate the ankle mobility when wearing the bandages, using a 6-point scale from insufficient, poor, acceptable, good, very good, to excellant.

Sponsors and collaborators

Lead sponsor

Lohmann & Rauscher

Industry

Registry information

Official study title

2023-05 Rosidal® 1C Pilot Study. Prospective, Mono-centric, Observational Randomized Controlled Study in Healthy Volunteers

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Dec 11, 2024
Registry last updated: Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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Completed