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Recruiting 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.

— Observational Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

2023-05 Rosidal® 1C Pilot Study. Prospective, Mono-centric, Observational Randomized Controlled Study in Healthy Volunteers

Overview

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.

Primary outcome measures

  • Percentage of subjects with static stiffness index SSI ≥ 10 mmHg over the course of 7 days [Time frame: Day 0, 1, 3, 7]
Secondary outcome measures (2)
  • Percentage of subjects with resting pressures higher than 20 mmHg and 40 mmHg up to day 7 [Time frame: Day 0, 1, 3, 7]
  • Rate of participants assessing the wearing comfort on a 6-level scale. [Time frame: Day 0, 1, 7]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Department of Clinical and Experimental Medicine, University of Pisa, UOC Dermatologia Uni — Pisa

Publications

  • 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

Identifiers

NCT: NCT06728137 · 2023-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗