This exploratory study is meant to assess the efficacy of a product in diabetic patients presenting foot xerosis and superficial fissures This exploratory study will be conducted as randomized, comparative study in parallel groups. In order to perform this clinical study, 60 female/male subjects, aged between 18 and 75 years old, with controlled type 1 or 2 diabetes and presenting foot xerosis and superficial fissures, are enrolled. The subjects are randomly divided in two groups, (Group I or Group II), where one group applies the test product and another group applies comparative product. The subjects apply the investigational/comparator products to both feet, twice a day, in the mornings and evenings, for 28 consecutive days. 3 visits are planned : * Visit 1: Inclusion (D1) * Visit 2: Intermediate visit (D5 ±2) * Visit 3: End-of-study visit (D28 ±2)
Age range
18 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Xerosis intensity on both feet with XAS (Xerosis Assessment Scale)
Timeframe: Before (Day 1 Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Evolution of superficial fissures intensity on both feet with VAS (Visual Analog Scale)
Timeframe: After 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application compared to baseline (Day 1, Visit 1)
Evolution of superficial fissures intensity on a target fissure with VAS (Visual Analog Scale)
Timeframe: After 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application compared to baseline (Day 1, Visit 1)
Quality of Life evaluation by the patient
Timeframe: Before (Day 1, Visit 1), and after 28 (Visit 3) consecutive days of products' application
Global soothing effect evaluation on feet
Timeframe: After the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Intensity of pruritus/itchiness on feet
Timeframe: Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Intensity of tingling on feet
Timeframe: Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Intensity of tightness on feet
Timeframe: Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Intensity of pain on feet
Timeframe: Before (Day 1, Visit 1) and immediately after the first application (Day 1, Visit 1), and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Skin hydration
Timeframe: Before (Day 1, Visit 1) and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Standardized photographs of the target fissure of each subject to visually assess the evolution of the target fissure.
Timeframe: Before (Day 1, Visit 1) and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Cosmetic satisfaction and perceived effect evaluation questionnaire
Timeframe: After the first application (Day 1, Visit 1), and after 5 (Visit 2), 15 (at home) and 28 (Visit 3) consecutive days of products' application
Standardized photograph of the selected foot of each subject is taken for illustrative purposes
Timeframe: Before (Day 1, Visit 1) and after 5 (Visit 2) and 28 (Visit 3) consecutive days of products' application
Compliance of the subject to the product
Timeframe: During the entire course of the study, from inclusion visit (Day 1), to the end-of-study visit (Day 28).
Global assessment of the tolerance
Timeframe: At the end of the study (after 28 consecutive days of products' twice-daily application), or premature withdrawal