Blinded User Study for the Evaluation of the Acceptability and Efficacy of One Medical Device in Venous Return in Comparison With a Control Group

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 the initial measurements, by self-assessment, filling-in questions regarding Quality of Life, in comparison with a control group.

The secondary goal of this study is to assess in vivo the acceptability of the subjects regarding the same medical device, after 14 days of using the medical device, by selfassessment, filling-in subjective evaluation questions.

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Key information

Conditions

Venous Disease Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Symptoms and Signs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inovapotek

Porto, 4200-135, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
With a score >14 from the question 1 to 11 of the adapted CIVIQ questionnaire;
With shoes suitable for insoles (with heel <2.5cm);
Having a size of 36 to 44;
Is taking a venotonic as a regular therapy with a daily dosage;

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 (under the 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.

Treatment and study plan

Insoles

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 a usability's questionnaire at Day14.

Primary outcomes

Quality of Life

Time frame: Day 0 and Day 14

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;

Secondary outcomes

Usability evaluation

Time frame: Day 14

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

Sponsors and collaborators

Lead sponsor

Millet Innovation

Industry

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: May 1, 2024
Registry last updated: May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed