Consumer Study for the Evaluation of the Usability and Efficacy of One Medical Device in Venous Return

Study Overview
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Brief Summary
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The primary goal of this study is to assess in vivo the efficacy of the insoles in improving venous return in subjects affected by this problem after 14 days of medical device use, by self-assessment, filling-in questions regarding Quality of Life, in comparison to the baseline. The secondary goals of this study are (1) to assess in vivo the perception of subjects about the rapid relief felt after 7 days of using the same medical device, by self-assessment, filling-in three subjective evaluation questions, and (2) to assess in vivo the usability of the subjects regarding the same medical device after 14 days of its use, by self-assessment, filling-in subjective evaluation questions.

Official Title
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Consumer Study for the Evaluation of the Usability and Efficacy of One Medical

Conditions
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Venous Disease, Quality of Life, Symptoms and Signs

Intervention / Treatment
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* Device: Insoles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gender: Female/Male; Age: with 18 years old and older; Having signed an Informed Consent Form (ICF); Willingness, ability and likeliness to comply with all the study procedures and restrictions; Ability to give informed consent; Available during the entire study period; Understanding Portuguese language: Portuguese-speaking subjects capable of reading the documents; Affected by a symptomatic venous return problem; Exclusion Criteria: Known allergy or known history of hypersensitivity to the components of the investigational device and related compounds; Currently participating in another clinical study that may interfere with the study; Diagnosed skin diseases and/or cutaneous alterations on the test region (feet) that may impair the study (for example tattoos, marks, burns, scars, etc.); Diagnosed diseases that may impair the study (including but not limited to: Diabetes, Arteritis, Phlebitis, etc); Under pharmacological treatments on the 30 days previous to the beginning of the study and during the entire period of the study that may impair it (including but not limited to: inflammatory drugs, any drug that might cover the signs and symptoms, drugs with arterial or venous indications, etc.); Having applied any type of topical product (pharmaceutical, cosmetic or other) with similar effect of the medical device under study, on the test region (feet) during the study, besides the investigational device; Having a stage of CVD C3 on the CEAP classification; Having had a traumatic or neurological history in the last 6 months; Wearing an orthopaedic insole made by a health professional; Having a significant and disabling lower limb pain; Having a significant and disabling back pain; Having a contraindication to wearing insoles; Pregnancy or intention to conceive during the study; Breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One medical device as investigational device<br> | Device: Insoles<br>* Device : Insoles At Day 0, the patient received the insoles and adapted them to his shoes. The patient filled the quality-of-life's questionnaire at Day 0 and the same at Day14. The patient filled the rapid relief's questionnaire at Day7 and a usability's questionnaire at Day14.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Quality of Life evaluation before (t0) and after 14 days (t14) of using the medical device Therapeutic insoles LIGHT LEGS, to assess the quality-of-life improvement subjects; | Day 0 and Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rapid relief | Perception of subjects about the rapid relief felt after 7 days (t7) of using the medical device, by self-assessment, filling-in three subjective evaluation questions | Day 7 | 
| Usability evaluation | Usability of the subjects regarding the same device, through subjective evaluation questions filled by the subjects after 14 days (t14) of using the medical device. | Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic venous disease, insoles, quality of life, symptoms, relief,