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

Primary Purpose

Metatarsalgia

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Hyaluronic acid

About this trial

This is an interventional treatment trial for Metatarsalgia

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Dr Foumenteze

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyaluronic acid

Arm Description

Injections of hyaluronic acid under metatarsal heads

Outcomes

Primary Outcome Measures

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

Pain assessment (Time to maximum pain tolerance (TEnd)

(in hours): duration between first pain sensations and the maximal pain tolerance (removing shoes).

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02369380

First Posted

December 9, 2014

Last Updated

February 16, 2021

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT02369380

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galderma R&D

4. Oversight

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metatarsalgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hyaluronic acid

Arm Type

Experimental

Arm Description

Injections of hyaluronic acid under metatarsal heads

Intervention Type

Device

Intervention Name(s)

Hyaluronic acid

Intervention Description

Injections of Hyaluronic acid under the metatarsal heads

Primary Outcome Measure Information:

Title

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

Description

Time to onset of pain (TInitial) (in hours): duration between beginning of wearing high heel shoes and first pain sensations

Time Frame

Subject questioning at baseline after injections and change from baseline 1 month after baseline

Title

Pain assessment (Time to maximum pain tolerance (TEnd)

Description

(in hours): duration between first pain sensations and the maximal pain tolerance (removing shoes).

Time Frame

Subject questioning at baseline after injections and change from baseline 1 month after baseline

Secondary Outcome Measure Information:

Title

Podiatric criteria

Description

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

Time Frame

Change from baseline 6 months after baseline

Title

Podiatric criteria (Baro Podometric static examinations)

Description

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

Time Frame

Change from baseline 6 months after baseline

Other Pre-specified Outcome Measures:

Title

Subject overall satisfaction

Description

Overall satisfaction of subjects with injections outcome

Time Frame

6 months after baseline injections

Title

Adverse Events

Description

Occurence of adverse events during the study

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean Paul Foumenteze, Dr

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr Foumenteze

City

Cannes

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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