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

NCT02369380 | Completed

• 1 other identifier: RD.03.SPR.29108
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Metatarsalgia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Podiatric criteria

  Change from baseline 6 months after baseline

• Podiatric criteria (Baro Podometric static examinations)

  Change from baseline 6 months after baseline

Other Outcomes (2)

• Subject overall satisfaction

  6 months after baseline injections

• Adverse Events

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

Study Arms (1)

Hyaluronic acid

EXPERIMENTAL

Injections of hyaluronic acid under metatarsal heads

Device: Hyaluronic acid

Interventions

Hyaluronic acid DEVICE

Injections of Hyaluronic acid under the metatarsal heads

Hyaluronic acid

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Dr Foumenteze

Cannes, France

Location

MeSH Terms

Conditions

Metatarsalgia

Condition Hierarchy (Ancestors)

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

Study Officials

• Jean Paul Foumenteze, Dr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: February 23, 2015
• Study Start: November 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 18, 2021

Record last verified: 2016-09

Locations

FR (1)