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Aim of this study is to evaluate the decrease of plantar pain of forefeet due to restoration of plantar pad tissue density and of cushioning function with an hyaluronic acid dermal filler as mechanical-supplementation in subjects with metatarsalgia further use of high heel shoes
This will be an open and single center study. There will be 4 study visits in total for each subject. Each subject will participate for a period of maximum 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic acid | Experimental | Injections of hyaluronic acid under metatarsal heads |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid | Device | Injections of Hyaluronic acid under the metatarsal heads |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment (Time to onset of pain (TInitial) (in hours) | Time to onset of pain (TInitial) (in hours): duration between beginning of wearing high heel shoes and first pain sensations | Subject questioning at baseline after injections and change from baseline 1 month after baseline |
| Pain assessment (Time to maximum pain tolerance (TEnd) | (in hours): duration between first pain sensations and the maximal pain tolerance (removing shoes). | Subject questioning at baseline after injections and change from baseline 1 month after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Podiatric criteria | Baro Podometric static examinations assessed by podiatrist at Baseline, 1 month, 3 months and 6 months after baseline to measure: - Mean pressure under metatarsal heads | Change from baseline 6 months after baseline |
| Podiatric criteria (Baro Podometric static examinations) |
| Measure | Description | Time Frame |
|---|---|---|
| Subject overall satisfaction | Overall satisfaction of subjects with injections outcome | 6 months after baseline injections |
| Adverse Events | Occurence of adverse events during the study |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Paul Foumenteze, Dr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Foumenteze | Cannes | France |
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| ID | Term |
|---|---|
| D037061 | Metatarsalgia |
| ID | Term |
|---|---|
| D005534 | Foot Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D010146 | Pain |
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Baro Podometric static examinations assessed by podiatrist at Baseline, 1 month, 3 months and 6 months after baseline to measure: - Maximum mean pressure under metatarsal heads |
| Change from baseline 6 months after baseline |
| At each follow up visit:1 month, 3 months and 6 months after baseline |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |