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

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

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

Study Overview

• Status: Completed
• Conditions: Metatarsalgia
• Intervention / Treatment: Device: Hyaluronic acid

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Cannes, France
    • Dr Foumenteze

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyaluronic acid; Injections of hyaluronic acid under metatarsal heads	Device: Hyaluronic acid; Injections of Hyaluronic acid under the metatarsal heads

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject overall satisfaction	Overall satisfaction of subjects with injections outcome	6 months after baseline injections
Adverse Events	Occurence of adverse events during the study	At each follow up visit:1 month, 3 months and 6 months after baseline

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Jean Paul Foumenteze, Dr

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: December 9, 2014
• First Submitted That Met QC Criteria: February 17, 2015
• First Posted (Estimate): February 23, 2015

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Foot Diseases; Joint Diseases; Musculoskeletal Diseases; Metatarsalgia; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: RD.03.SPR.29108