Phase
Condition
Healthy Volunteers
Treatment
N/AClinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy intact skin with no clinical signs of chronic venous insufficiency and nosigns of any dermatological condition such as eczema or psoriasis as assessed byinvestigating physician.
Ankle circumference > 18 cm (2 cm above ankle) as assessed by the investigatingphysician.
Exclusion
Exclusion Criteria:
Known sensitivity to the study products (Rosidal 1C or Urgo K1) or any of theircomponents
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 capillaryinfiltration
Comorbidities that could affect compression therapy, particularly diseases causingoedema
Reliable severe malnutrition
Diabetes Mellitus
BMI > 30 kg/m2
Pregnancy or breast feeding
Participation in an interventional clinical trial within the last 3 months andduring participation in this study
Participant is analphabet
Study Design
Connect with a study center
Department of Clinical and Experimental Medicine, University of Pisa, UOC Dermatologia Universitaria, Santa Chiara Hospital AOUP
Pisa, 56126
ItalyActive - Recruiting
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