Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06728137

Investigation of a New Compression Bandage Combining Skin Protection, Padding, and Compression Prospective Observational Study Comparing Two Bandages in Healthy Volunteers

Led by Lohmann & Rauscher · Updated on 2025-01-13

25

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new compression bandage that combines skin protection, padding, and compression in a single bandage. The study involves healthy volunteers and aims to measure how well the bandage maintains pressure over seven days when applied to the lower legs. The pressure of this new bandage will be compared with that of an existing one-component bandage using a random assignment to each leg. The study involves applying the new bandage to one lower leg and the existing bandage to the other leg. The pressure under each bandage will be measured on the day of application, and then again on days 1, 3, and 7. Participants will also be asked about their comfort while wearing each bandage during the study period. Participants will be monitored through pressure measurements taken at specified intervals to assess the static stiffness index over seven days. Researchers will also collect feedback on wearing comfort. The total study duration includes these seven days of wearing the bandages, with no additional treatment or long-term follow-up mentioned.

CONDITIONS

Official Title

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.

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy intact skin with no signs of chronic venous insufficiency or dermatological conditions such as eczema or psoriasis as assessed by the investigating physician
  • Ankle circumference greater than 18 cm (measured 2 cm above the ankle) as assessed by the investigating physician
Not Eligible

You will not qualify if you...

  • Known sensitivity to the study products (Rosidal 1C or Urgo K1) or any of their components
  • Chronic venous disease with CEAP stage 2 or higher
  • Ankle Brachial Pressure Index (ABPI) less than 0.8 or greater than 1.3
  • Ankle circumference less than 18 cm or greater than 32 cm
  • Venous echo-Doppler showing 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, or psoriasis
  • Use of diuretics, antihypertension drugs, or drugs influencing capillary infiltration
  • Comorbidities affecting compression therapy, especially diseases causing edema
  • Severe malnutrition
  • Diabetes Mellitus
  • Body Mass Index (BMI) over 30 kg/m2
  • Pregnancy or breastfeeding
  • Participation in an interventional clinical trial within the last 3 months or during this study
  • Participant is illiterate

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

Pisa, Italy, 56126

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Research Team

C

Christine Boehm, MD PhD

M

Martin Abel, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

A prospective, monocentric, observational randomised controlled pilot study of two all-in-one multicomponent compression systems in healthy volunteers.

Valentina Dini, Antonella Vietina, Alessandra Michelucci...

https://pubmed.ncbi.nlm.nih.gov/41528788