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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Symptoms and Signs; Venous Disease
• Intervention / Treatment: Device: Insoles

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4200-135
    • Inovapotek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: One medical device as investigational device	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.

What is the study measuring?

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
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

Collaborators and Investigators

• Sponsor: Millet Innovation
• Investigators: Principal Investigator: Marta de Oliveira Ferreira, Study Principal Investigator, Inovapotek

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Chronic venous disease, insoles, quality of life, symptoms, relief, venotonic
• Other Study ID Numbers: P001D23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No