ELFE: Volume Restoration of Plantar Pad With a Hyaluronic Acid Dermal Filler in Metatarsalgia
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hyaluronic acid Injections of hyaluronic acid under metatarsal heads |
Device: Hyaluronic acid
Injections of Hyaluronic acid under the metatarsal heads
|
Outcome Measures
Primary Outcome Measures
- Pain assessment (Time to onset of pain (TInitial) (in hours) [Subject questioning at baseline after injections and change from baseline 1 month after baseline]
Time to onset of pain (TInitial) (in hours): duration between beginning of wearing high heel shoes and first pain sensations
- Pain assessment (Time to maximum pain tolerance (TEnd) [Subject questioning at baseline after injections and change from baseline 1 month after baseline]
(in hours): duration between first pain sensations and the maximal pain tolerance (removing shoes).
Secondary Outcome Measures
- Podiatric criteria [Change from baseline 6 months after baseline]
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
- Podiatric criteria (Baro Podometric static examinations) [Change from baseline 6 months after baseline]
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
Other Outcome Measures
- Subject overall satisfaction [6 months after baseline injections]
Overall satisfaction of subjects with injections outcome
- Adverse Events [At each follow up visit:1 month, 3 months and 6 months after baseline]
Occurence of adverse events during the study
Eligibility Criteria
Criteria
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,
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Subject who wishes to wear orthotic supports (shock-absorbing insoles or arch supports, etc…).
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Subject with history of bleeding disorders or or erysipelas of the lower limbs,
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Subject with chronic inflammatory pain of the feet due to other non-mechanical causes, such as plantar fasciitis, arthritis, gout, Morton's neuroma.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dr Foumenteze | Cannes | France |
Sponsors and Collaborators
- Galderma R&D
Investigators
- Principal Investigator: Jean Paul Foumenteze, Dr,
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RD.03.SPR.29108