MedTrace Logo

Investigate the Effect of EPITACT® Light Legs Therapeutic Insoles on the Symptoms and Quality of Life of Patients With Chronic Venous Disease

NCT06620120 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-10-01

No results posted yet for this study

Summary

The main objective is to evaluate the effect of wearing the insoles developed by Millet Innovation on the symptoms and quality of life of patients suffering from chronic venous disease.

Conditions

  • Venous Disease
  • Quality of Life
  • Symptoms and Signs

Interventions

DEVICE

Insoles

At the D0 visit, if the patient is assigned to the arm with insoles. The patient completes the quality of life and symptom evaluation questionnaires, the plesthysmographic evaluation test, the analysis of walking without insoles and the oedema measurement. Then, at D30, the patient repeated the same tests, with the exception of the gait and plesthysmographic evaluation tests. The patient then switched to the other arm.

OTHER

Without insoles

At the D0 visit, if the patient is assigned to the arm without insoles. The patient completes the quality of life and symptom evaluation questionnaires, the plesthysmographic evaluation test, the analysis of walking without insoles and the oedema measurement. Then, at D30, the patient repeated the same tests, with the exception of the gait and plesthysmographic evaluation tests. The patient then switched to the other arm.

Sponsors & Collaborators

  • Millet Innovation

    lead INDUSTRY

Principal Investigators

  • Samuel Beliard, Medical doctor · Centre Hospitalier Louis Pasteur 39100 Dole

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-02-11
Completion
2024-03-31

Countries

  • France

Study Locations

More Related Trials

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 NCT06620120 on ClinicalTrials.gov