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

Sponsor
Millet Innovation (Industry)
Overall Status
Completed
CT.gov ID
NCT06153680
Collaborator
(none)
52
Enrollment
1
Location
1
Arm
1.7
Actual Duration (Months)
31
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Insoles
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Consumer Study for the Evaluation of the Usability and Efficacy of One Medical
Actual Study Start Date :
May 10, 2023
Actual Primary Completion Date :
Jun 30, 2023
Actual Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: One medical device as investigational device

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.

Outcome Measures

Primary Outcome Measures

  1. Quality of Life [Day 0 and Day 14]

    Quality of Life evaluation before (t0) and after 14 days (t14) of using the medical device Therapeutic insoles LIGHT LEGS, to assess the quality-of-life improvement subjects;

Secondary Outcome Measures

  1. Rapid relief [Day 7]

    Perception of subjects about the rapid relief felt after 7 days (t7) of using the medical device, by self-assessment, filling-in three subjective evaluation questions

  2. Usability evaluation [Day 14]

    Usability of the subjects regarding the same device, through subjective evaluation questions filled by the subjects after 14 days (t14) of using the medical device.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Gender: Female/Male;

  • Age: with 18 years old and older;

  • Having signed an Informed Consent Form (ICF);

  • Willingness, ability and likeliness to comply with all the study procedures and restrictions;

  • Ability to give informed consent;

  • Available during the entire study period;

  • Understanding Portuguese language: Portuguese-speaking subjects capable of reading the documents;

  • Affected by a symptomatic venous return problem;

Exclusion Criteria:

  • Known allergy or known history of hypersensitivity to the components of the investigational device and related compounds;

  • Currently participating in another clinical study that may interfere with the study;

  • Diagnosed skin diseases and/or cutaneous alterations on the test region (feet) that may impair the study (for example tattoos, marks, burns, scars, etc.);

  • Diagnosed diseases that may impair the study (including but not limited to: Diabetes, Arteritis, Phlebitis, etc);

  • Under pharmacological treatments on the 30 days previous to the beginning of the study and during the entire period of the study that may impair it (including but not limited to: inflammatory drugs, any drug that might cover the signs and symptoms, drugs with arterial or venous indications, etc.);

  • Having applied any type of topical product (pharmaceutical, cosmetic or other) with similar effect of the medical device under study, on the test region (feet) during the study, besides the investigational device;

  • Having a stage of CVD C3 on the CEAP classification;

  • Having had a traumatic or neurological history in the last 6 months;

  • Wearing an orthopaedic insole made by a health professional;

  • Having a significant and disabling lower limb pain;

  • Having a significant and disabling back pain;

  • Having a contraindication to wearing insoles;

  • Pregnancy or intention to conceive during the study;

  • Breast-feeding

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inovapotek Porto Portugal 4200-135

Sponsors and Collaborators

  • Millet Innovation

Investigators

  • Principal Investigator: Marta de Oliveira Ferreira, INOVAPOTEK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Millet Innovation
ClinicalTrials.gov Identifier:
NCT06153680
Other Study ID Numbers:
  • P115B22
First Posted:
Dec 1, 2023
Last Update Posted:
Dec 1, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Millet Innovation
Chronic venous disease, insoles, quality of life, symptoms, relief,

Study Results

No Results Posted as of Dec 1, 2023