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.

Recruiting

• Conditions: Healthy Volunteers

• Registration Number: NCT06728137
• Lead Sponsor: Lohmann & Rauscher

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-11
• Status Verified: 2025-01
• Study Start: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-03
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with static stiffness index SSI ≥ 10 mmHg over the course of 7 days	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 Outcome Measures

Name	Time	Method
Percentage of subjects with resting pressures higher than 20 mmHg and 40 mmHg up to day 7	Day 0, 1, 3, 7	The resting pressures are obtained during muscle relaxation or rest when the participant is lying.
Rate of participants assessing the wearing comfort on a 6-level scale.	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.

Trial Locations

Locations (1)

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