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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06395025
• Other study ID #: P001D23
• Status: Completed
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: April 2024
• Source: Millet Innovation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Quality of Life
• Symptoms and Signs
• Venous Disease

Intervention

Device:
• Insoles
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.

Locations

Country	Name	City	State
Portugal	Inovapotek	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Millet Innovation

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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