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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
62
Twice daily applications on both feet. The product will be applied according to randomization on the entire feet in a sufficient amount.
Twice daily applications on both feet. The product will be applied according to randomization on the entire feet in a sufficient amount.
Inovapotek
Porto, Portugal
Xerosis intensity on both feet with XAS (Xerosis Assessment Scale)
Evaluation performed by the investigator, giving 1 XAS score for both feet/patient (9 points scale, from 0 = Normal skin, to 8 =Skin with deep fissures).
Time frame: 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)
Evaluation performed by the investigator, giving 1 VAS score for both feet/patient (continuous sliding scale from 0 mm = no repair/no improvement to 100 mm = complete repair/full improvement).
Time frame: 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)
Evaluation performed by the investigator specifically on the target fissure identified at the inclusion visit, on VAS (continuous sliding scale from 0 mm = no repair/no improvement to 100 mm = complete repair/full improvement).
Time frame: 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
Filling by the patient of a 13-questions questionnaire about their quality of life related to their feet condition.
Time frame: Before (Day 1, Visit 1), and after 28 (Visit 3) consecutive days of products' application
Global soothing effect evaluation on feet
The global soothing is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no relief/no soothing effect to 100 mm = complete relief/total soothing effect)
Time frame: 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
The evolution of pruritus intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no itching or pruritus at all, to 100 mm = extreme itching, unbearable)
Time frame: 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
The evolution of tingling intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no tingling sensation, to 100 mm = intense tingling, very uncomfortable)
Time frame: 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
The evolution of tightness intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no tightness at all, to 100 mm = extreme tightness, uncomfortable)
Time frame: 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
The evolution of pain intensity on feet is assessed by each subject using a VAS (continuous sliding scale from 0 mm = no pain at all, to 100 mm = extreme pain, debilitating)
Time frame: 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
Skin capacitance is assessed instrumentally by an expert, on the selected foot of each subject
Time frame: 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.
Time frame: 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
Filling by the patient of a subjective evaluation questionnaire considering their cosmetic acceptability, and perceived efficacy towards the investigational/comparator product
Time frame: 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
Time frame: 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
Subjects fill in a subject diary (daily log) during the course of the study to record their compliance to the product.
Time frame: 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
Global assessment of the tolerance is assessed by the investigator for each subject at the end of the study considering all individual adverse events and their characteristics, based on a 5-point scale (from excellent tolerance to bad tolerance).
Time frame: At the end of the study (after 28 consecutive days of products' twice-daily application), or premature withdrawal
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