Status:
COMPLETED
Consumer Study for the Evaluation of the Usability and Efficacy of One Medical Device in Venous Return
Lead Sponsor:
Millet Innovation
Conditions:
Venous Disease
Quality of Life
Eligibility:
All Genders
18+ years
Phase:
NA
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06153680
Start Date
May 10 2023
End Date
June 30 2023
Last Update
December 1 2023
Active Locations (1)
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1
Inovapotek
Porto, Portugal, 4200-135