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Completed

NCT Number: NCT02369380

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

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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Key information

Conditions

Metatarsalgia Foot Diseases Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dr Foumenteze

Cannes, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyaluronic Acid

Device

Injections of Hyaluronic acid under the metatarsal heads

Primary outcomes

  1. Pain assessment (Time to onset of pain (TInitial) (in hours)

    Time frame: 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

  2. Pain assessment (Time to maximum pain tolerance (TEnd)

    Time frame: 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 outcomes

  1. Podiatric criteria

    Time frame: 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

  2. Podiatric criteria (Baro Podometric static examinations)

    Time frame: 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 outcomes

  1. Subject overall satisfaction

    Time frame: 6 months after baseline injections

    Overall satisfaction of subjects with injections outcome

  2. Adverse Events

    Time frame: At each follow up visit:1 month, 3 months and 6 months after baseline

    Occurence of adverse events during the study

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Acronym: ELFE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 23, 2015
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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