Venous DiseaseNCT06395025
Blinded User Study for the Evaluation of the Acceptability and Efficacy of One Medical Device in Venous Return in Comparison With a Control Group
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 the initial measurements, by self-assessment, filling-in questions regarding Quality of Life, in comparison with a control group. 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
- 110 participants
- Where
- 1 sitePortugal
- Study dates
- 17 Oct 2023to 29 Feb 2024
- 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;
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- 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;
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 (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;
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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
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
- Being tested
- Insoles
- Keywords
- Chronic venous disease, insoles, quality of life, symptoms, relief, venotonic
- 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
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.
| Study group | Role | What they receive |
|---|---|---|
| One medical device as investigational device | Experimental | Not described Receives: Device: Insoles |
| control group | No intervention | Not described |
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 (1)
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 May 2024
- Study start17 Oct 2023
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- one group versus a control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millet Innovation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marta de Oliveira Ferreira, Study Principal Investigator, Principal investigator, INOVAPOTEK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395025
- Sponsor's protocol ID
- P001D23
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 1 May 2024
- 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 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06395025
- Acronym / sponsor ID
- P001D23
- Conditions
- Venous Disease, Quality of Life, Symptoms and Signs
- Keywords
- Chronic venous disease, insoles, quality of life, symptoms, relief, venotonic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Millet InnovationIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 1 May 2024 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- one group versus a control group
| Arm | Type | Receives |
|---|---|---|
| One medical device as investigational device | Experimental | Device: Insoles |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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 (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.);
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 |
|---|---|---|
| InsolesInsoles 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. | 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;
1 secondary outcome
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 May 2024.
- 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, Study Principal Investigator 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 12 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 May 2024. 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 May 2024.