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

NCT ID: NCT06395025

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-17
• Study Completion Date: 2024-02-29

Brief 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.

Conditions

Venous Disease; Quality of Life; Symptoms and Signs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

One medical device as investigational device

Group Type: EXPERIMENTAL

Insoles

Intervention Type: 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.

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millet Innovation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marta de Oliveira Ferreira, Study Principal Investigator

Role: PRINCIPAL_INVESTIGATOR

INOVAPOTEK

Locations

Inovapotek

Porto, , Portugal

Countries

Portugal

Other Identifiers

P001D23

Identifier Type: -

Identifier Source: org_study_id