Volume Restoration of Plantar Pad With a Hyaluronic Acid Dermal Filler in Metatarsalgia

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Volume Restoration of Plantar Pad With a Hyaluronic Acid Dermal Filler in Treatment of Metatarsalgia of Forefeet Further Use of High Heel Shoes

Conditions
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Metatarsalgia

Intervention / Treatment
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* Device: Hyaluronic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subject aged 30 years or older, Subject with pain sensation under metatarsal heads, further to use of high heels shoes at any moment of the day whatever the onset time, Subject with no previous injections under the metatarsal heads of forefeet. Exclusion Criteria: Subject with a personal history of allergic/anaphylactic reactions including hypersensitivity to crossed-linked hyaluronic acid and to Lidocaine or amide local anesthetics Subject with cutaneous infection on either foot or with history of autoimmune diseases or auto-inflammatory diseases, Subject who wishes to wear orthotic supports (shock-absorbing insoles or arch supports, etc…). Subject with history of bleeding disorders or or erysipelas of the lower limbs, Subject with chronic inflammatory pain of the feet due to other non-mechanical causes, such as plantar fasciitis, arthritis, gout, Morton's neuroma.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic acid<br>Injections of hyaluronic acid under metatarsal heads | Device: Hyaluronic acid<br>* Injections of Hyaluronic acid under the metatarsal heads<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |