Testing a new compression bandage system on healthy volunteers
2023-05 Rosidal® 1C Pilot Study. Prospective, Mono-centric, Observational Randomized Controlled Study in Healthy Volunteers
This study is testing a new type of compression bandage on healthy volunteers to see if it works better and feels more comfortable than a standard bandage.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lohmann & Rauscher Industry-sponsored |
| Locations | 1 site (Pisa) |
| Trial ID | NCT06728137 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a new compression bandage that combines skin protection, padding, and compression in one product. Healthy volunteers will have the bandage applied to one lower leg, while a similar existing bandage will be applied to the other leg. The study will measure the pressure maintained by both bandages over seven days and assess the comfort level reported by participants. A randomized method will be used to assign the bandages to each leg, ensuring a controlled comparison.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals with intact skin and an ankle circumference between 18 cm and 32 cm.
Not a fit: Patients with chronic venous disease, significant skin conditions, or other specified health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved compression bandage designs that enhance patient comfort and effectiveness.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating this may be a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pisa
- Department of Clinical and Experimental Medicine, University of Pisa, UOC Dermatologia Universitaria, Santa Chiara Hospital AOUP — Pisa, Italy (Recruiting)
Study contacts
- Principal investigator: Prof. Dr. Valentina Dini — Department of Clinical and Experimental Medicine, University of Pisa
- Study coordinator: Christine Boehm, MD PhD
- Email: Christine.Boehm@de.LRmed.com
- Phone: +49 2634 996144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.