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

NCT07234240 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-11-18

No results posted yet for this study

Summary

The primary goal of this study was to assess, in vivo, the efficacy of the medical device Invisible insoles LIGHT LEGS 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 were (1) to assess in vivo the perception of subjects about the rapid relief felt after 7 days of using the same medical device, by selfassessment, 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.

Conditions

  • Venous Disease
  • Quality of Life
  • Symptoms and Signs

Interventions

DEVICE

Insoles

Insoles At Day 0, the patient received the insoles and adapted them to his open 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.

Sponsors & Collaborators

  • Millet Innovation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-05
Primary Completion
2025-09-11
Completion
2025-09-11

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07234240 on ClinicalTrials.gov