NCT06395025

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Millet Innovation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-17
• Primary completion: 2024-02-29
• Completion: 2024-02-29
• First posted: 2024-05-01
• Last updated: 2024-05-01

Locations

1 site across 1 country: Portugal