NCT06153680

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

Consumer Study for the Evaluation of the Usability and Efficacy of One Medical

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (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 medical device use, by self-assessment, filling-in questions regarding Quality of Life, in comparison to the baseline. The secondary goals of this study are (1) to assess in vivo the perception of subjects about the rapid relief felt after 7 days of using the same medical device, by self-assessment, 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

Type	Name	Description
DEVICE	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 the rapid relief's questionnaire at Day7 and a usability's questionnaire at Day14.

Timeline

• Start date: 2023-05-10
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2023-12-01
• Last updated: 2023-12-01

Locations

1 site across 1 country: Portugal