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Completed

NCT Number: NCT06153680

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

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.

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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;

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

Treatment and study plan

Insoles

Device

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.

Primary outcomes

  1. 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

  1. Rapid relief

    Time frame: Day 7

    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

  2. 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

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 1, 2023
Registry last updated
Dec 1, 2023

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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