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

NCT06153680 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-12-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Millet Innovation

    lead INDUSTRY

Principal Investigators

  • Marta de Oliveira Ferreira · INOVAPOTEK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-10
Primary Completion
2023-06-30
Completion
2023-06-30

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 NCT06153680 on ClinicalTrials.gov