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.

NCT06728137 | Recruiting

• 1 other identifier: 2023-05
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

prospective; monocentric; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

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

  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.

  Day 0, 1, 3, 7

Secondary Outcomes (2)

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

  Day 0, 1, 3, 7

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

  Day 0, 1, 7

Study Arms (1)

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Apparently healthy volunteers

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lohmann & Rauscher: lead

Study Sites (1)

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

Pisa, 56126, Italy

RECRUITING

Related Publications (1)

• Dini V, Vietina A, Michelucci A, Rizzello F, Romanelli M, Mosti G, Namislo A, Bohm C, Abel M. A prospective, monocentric, observational randomised controlled pilot study of two all-in-one multicomponent compression systems in healthy volunteers. J Wound Care. 2026 Jan 2;35(1):26-34. doi: 10.12968/jowc.2025.0456.

  PMID: 41528788 DERIVED

Study Officials

• Prof. Dr. Valentina Dini

  Department of Clinical and Experimental Medicine, University of Pisa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Boehm, MD PhD

CONTACT

+49 2634 996144; Christine.Boehm@de.LRmed.com

Martin Abel, PhD

CONTACT

+49 2631 996566; Martin.Abel@de.LRmed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 11, 2024
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)