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.

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06728137

Enrollment

Registered

2024-12-11

Start date

2025-01-14

Completion date

2025-04-20

Last updated

2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

prospective, monocentric, randomized controlled trial

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Static Stiffness Index SSI	Day 0	The static stiffness index is the sub-bandge pressure difference between active standing and lying.

Secondary

Measure	Time frame	Description
Number of Participants Assessing the Wearing Comfort by Ankle Mobility as Acceptable or Better	Day 0 + 6 days	Participants were asked on the last day how they rate the ankle mobility when wearing the bandages, using a 6-point scale from insufficient, poor, acceptable, good, very good, to excellant.
Sub-bandage Resting Pressure After One Week of Contionous Wearing of the Comprression Bandages	Day 0 + 6 days	The sub-bandage resting pressures are measured during muscle relaxation or rest when the participant is lying.

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORProf. Dr. Valentina Dini

Department of Clinical and Experimental Medicine, University of Pisa

Participant flow

Recruitment details

Investigational Device

Baseline characteristics

Characteristic	—
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	22 Participants
Age, Continuous	33 years
Region of Enrollment Italy	22 participants
Sex: Female, Male Female	14 Participants
Sex: Female, Male Male	8 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 22	0 / 22
other Total, other adverse events	1 / 22	1 / 22
serious Total, serious adverse events	0 / 22	0 / 22

Outcome results