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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-10-31

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

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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.

Conditions

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Metatarsalgia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyaluronic acid

Injections of hyaluronic acid under metatarsal heads

Group Type EXPERIMENTAL

Hyaluronic acid

Intervention Type DEVICE

Injections of Hyaluronic acid under the metatarsal heads

Interventions

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Hyaluronic acid

Injections of Hyaluronic acid under the metatarsal heads

Intervention Type DEVICE

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.

Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No