Clinical trial NCT06395025: Blinded User Study for the Evaluation of the Acceptability and Efficacy of One Medical Device in Venous Return in Comparison With a Control Group
Official title: Blinded User Study for the Evaluation of the Acceptability and Efficacy of One Medical Device in Venous Return in Comparison With a Control Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Disease
Quality of Life
Symptoms and Signs
Keywords: Chronic venous disease, insoles, quality of life, symptoms, relief, venotonic
Lead sponsor: Millet Innovation
Sponsor class: INDUSTRY
First posted: 2024-05-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one group versus a control group
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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;
* With a score \>14 from the question 1 to 11 of the adapted CIVIQ questionnaire;
* With shoes suitable for insoles (with heel \<2.5cm);
* Having a size of 36 to 44;
* Is taking a venotonic as a regular therapy with a daily dosage;

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 (under the 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.

Primary outcomes:
measure: Quality of Life
timeFrame: Day 0 and Day 14
Secondary outcomes:
measure: Usability evaluation
timeFrame: Day 14
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Inovapotek
Study officials:
affiliation: INOVAPOTEK
name: Marta de Oliveira Ferreira, Study Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References: