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

Galderma

Status

Completed

Conditions

Metatarsalgia

Treatments

Device: Hyaluronic acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT02369380

RD.03.SPR.29108

Details and patient eligibility

About

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

Full 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.

Enrollment

15 patients

Sex

Female

Ages

30+ years old

Volunteers

No Healthy Volunteers

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.