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

Metatarsalgia Clinical Trial

— ELFE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369380
• Other study ID #: RD.03.SPR.29108
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: October 2015

Study information

• Verified date: September 2016
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metatarsalgia

Intervention

Device:
• Hyaluronic acid
Injections of Hyaluronic acid under the metatarsal heads

Locations

Country	Name	City	State
France	Dr Foumenteze	Cannes

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subject overall satisfaction	Overall satisfaction of subjects with injections outcome	6 months after baseline injections
Other	Adverse Events	Occurence of adverse events during the study	At each follow up visit:1 month, 3 months and 6 months after baseline
Primary	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
Primary	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	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
Secondary	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