Healthy VolunteersNCT06728137
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.
An observational study of Healthy Volunteers, run by Lohmann & Rauscher at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jan 2025to 20 Apr 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Apparently healthy volunteers
Who may be able to join
- 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.
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Clinical and Experimental Medicine, University of Pisa, UOC Dermatologia Universitaria, Santa Chiara Hospital AOUP
Pisa, 56126
About this study
Official title: 2023-05 Rosidal® 1C Pilot Study. Prospective, Mono-centric, Observational Randomized Controlled Study in Healthy Volunteers
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Stiffness Index SSI
The static stiffness index is the sub-bandge pressure difference between active standing and lying.
Measured: Day 0
Secondary outcomes (2)
Sub-bandage Resting Pressure After One Week of Contionous Wearing of the Comprression Bandages
The sub-bandage resting pressures are measured during muscle relaxation or rest when the participant is lying.
Measured: Day 0 + 6 days
Number of Participants Assessing the Wearing Comfort by Ankle Mobility as Acceptable or Better
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.
Measured: Day 0 + 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start14 Jan 2025
- Primary completion3 Mar 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lohmann & Rauscher
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. Valentina Dini, Principal investigator, Department of Clinical and Experimental Medicine, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728137
- Sponsor's protocol ID
- 2023-05
- Status last verified
- Jan 2025
- First submitted
- 5 Dec 2024
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41528788
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2023-05 Rosidal® 1C Pilot Study. Prospective, Mono-centric, Observational Randomized Controlled Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06728137
- Acronym / sponsor ID
- 2023-05
- Conditions
- Healthy Volunteers
- Keywords
- prospective, monocentric, randomized controlled trial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Lohmann & RauscherIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Posted 31 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Apparently healthy volunteers
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Static Stiffness Index SSI
Time frame: Day 0
The static stiffness index is the sub-bandge pressure difference between active standing and lying.
2 secondary outcomes
Sub-bandage Resting Pressure After One Week of Contionous Wearing of the Comprression Bandages
Time frame: Day 0 + 6 days
Number of Participants Assessing the Wearing Comfort by Ankle Mobility as Acceptable or Better
Time frame: Day 0 + 6 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41528788Dini 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.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. Valentina Dini principal investigator
Department of Clinical and Experimental Medicine, University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Lohmann & Rauscher at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Stiffness Index SSI (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06728137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.