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NCT Number: NCT06728137

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.

Recruiting

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Key information

Conditions

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

Location status: Recruiting

Location contact

Prof. Dr. Valentina Dini

CONTACT

[email protected]

+ 39 50 992660

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

  1. Percentage of subjects with static stiffness index SSI ≥ 10 mmHg over the course of 7 days

    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.

Secondary outcomes

  1. Percentage of subjects with resting pressures higher than 20 mmHg and 40 mmHg up to day 7

    Time frame: Day 0, 1, 3, 7

    The resting pressures are obtained during muscle relaxation or rest when the participant is lying.

  2. Rate of participants assessing the wearing comfort on a 6-level scale.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Boehm, MD PhD

CONTACT

[email protected]

+49 2634 996144

Martin Abel, PhD

CONTACT

[email protected]

+49 2631 996566

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
Jan 13, 2025

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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