Venous DiseaseNCT06153680
Consumer Study for the Evaluation of the Usability and Efficacy of One Medical Device in Venous Return
A study testing Insoles in people with Venous Disease and Quality of Life, run by Millet Innovation at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Disease, Quality of Life, Symptoms and Signs
- What is being tested?
- Insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePortugal
- Study dates
- 10 May 2023to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consumer Study for the Evaluation of the Usability and Efficacy of One Medical
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
- Being tested
- Insoles
- Keywords
- Chronic venous disease, insoles, quality of life, symptoms, relief,
- Medical subject headings
- Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsolesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| One medical device as investigational device | Experimental | Not described Receives: Device: Insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
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;
Measured: Day 0 and Day 14
Secondary outcomes (2)
Rapid relief
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
Measured: Day 7
Usability evaluation
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.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start10 May 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millet Innovation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marta de Oliveira Ferreira, Principal investigator, INOVAPOTEK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153680
- Sponsor's protocol ID
- P115B22
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consumer Study for the Evaluation of the Usability and Efficacy of One Medical
- ClinicalTrials.gov ID
- NCT06153680
- Acronym / sponsor ID
- P115B22
- Conditions
- Venous Disease, Quality of Life, Symptoms and Signs
- Keywords
- Chronic venous disease, insoles, quality of life, symptoms, relief,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Millet InnovationIndustry (pharma, biotech, devices)
- Study start
- 10 May 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One medical device as investigational device | Experimental | Device: Insoles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (14 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsolesDevice : 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. | Device | One medical device as investigational device |
Primary outcome
Quality of Life
Time frame: 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;
2 secondary outcomes
Rapid relief
Time frame: Day 7
Usability evaluation
Time frame: Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta de Oliveira Ferreira principal investigator
INOVAPOTEK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insoles in people with Venous Disease and Quality of Life, run by Millet Innovation at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: Day 0 and Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.