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

NCT06395025 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-05-01

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 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

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.

Sponsors & Collaborators

  • Millet Innovation

    lead INDUSTRY

Principal Investigators

  • Marta de Oliveira Ferreira, Study Principal Investigator · INOVAPOTEK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-17
Primary Completion
2024-02-29
Completion
2024-02-29

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 NCT06395025 on ClinicalTrials.gov