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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One medical device as investigational device | Experimental |
| |
| control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 a usability's questionnaire at Day14. |
| Measure | Description | Time Frame |
|---|---|---|
| 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; | Day 0 and Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta de Oliveira Ferreira, Study Principal Investigator | INOVAPOTEK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inovapotek | Porto | 4200-135 | Portugal |
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one group versus a control group
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| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D061826 | Foot Orthoses |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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