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

NCT06395025 | Completed DMC

• 1 other identifier: P001D23
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic venous disease, insoles, quality of life, symptoms, relief, venotonic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Usability evaluation

  Day 14

Study Arms (2)

One medical device as investigational device

EXPERIMENTAL

Device: Insoles

control group

NO INTERVENTION

Interventions

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.

One medical device as investigational device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Millet Innovation: lead

Study Sites (1)

Inovapotek

Porto, 4200-135, Portugal

Location

MeSH Terms

Conditions

Signs and Symptoms

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Marta de Oliveira Ferreira, Study Principal Investigator

  INOVAPOTEK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: one group versus a control group

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 1, 2024
• Study Start: October 17, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)