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.

Last updated: January 9, 2025
Sponsor: Lohmann & Rauscher
Overall Status: Active - Recruiting

Phase

N/A

Condition

Healthy Volunteers

Treatment

N/A

Clinical Study ID

NCT06728137
2023-05
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy intact skin with no clinical signs of chronic venous insufficiency and nosigns of any dermatological condition such as eczema or psoriasis as assessed byinvestigating physician.

  • Ankle circumference > 18 cm (2 cm above ankle) as assessed by the investigatingphysician.

Exclusion

Exclusion Criteria:

  • Known sensitivity to the study products (Rosidal 1C or Urgo K1) or any of theircomponents

  • 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 capillaryinfiltration

  • Comorbidities that could affect compression therapy, particularly diseases causingoedema

  • Reliable severe malnutrition

  • Diabetes Mellitus

  • BMI > 30 kg/m2

  • Pregnancy or breast feeding

  • Participation in an interventional clinical trial within the last 3 months andduring participation in this study

  • Participant is analphabet

Study Design

Total Participants: 25
Study Start date:
January 01, 2025
Estimated Completion Date:
April 30, 2025

Connect with a study center

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

    Pisa, 56126
    Italy

    Active - Recruiting

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