Metatarsalgia
Conditions
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
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.
Interventions
DEVICEHyaluronic acid
Injections of Hyaluronic acid under the metatarsal heads
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed