MetatarsalgiaELFENCT02369380
Volume Restoration of Plantar Pad With a Hyaluronic Acid Dermal Filler in Metatarsalgia
A study testing Hyaluronic acid in people with Metatarsalgia, run by Galderma R&D at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Metatarsalgia
- What is being tested?
- Hyaluronic acid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Metatarsalgia
- Being tested
- Hyaluronic acid
- Medical subject headings
- Metatarsalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidDevice
Injections of Hyaluronic acid under the metatarsal heads
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid | Experimental | Injections of hyaluronic acid under metatarsal heads Receives: Device: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: Subject questioning at baseline after injections and change from baseline 1 month after baseline
Secondary outcomes (2)
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
Measured: 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
Measured: Change from baseline 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetatarsalgiaStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Paul Foumenteze, Dr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369380
- Sponsor's protocol ID
- RD.03.SPR.29108
- Acronym
- ELFE
- Status last verified
- Sep 2016
- First submitted
- 9 Dec 2014
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02369380
- Acronym / sponsor ID
- ELFE / RD.03.SPR.29108
- Conditions
- Metatarsalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid | Experimental | Device: Hyaluronic acidInjections of hyaluronic acid under metatarsal heads |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acidInjections of Hyaluronic acid under the metatarsal heads | Device | Hyaluronic acid |
Primary outcome
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
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).
2 secondary outcomes
Podiatric criteria
Time frame: Change from baseline 6 months after baseline
Podiatric criteria (Baro Podometric static examinations)
Time frame: Change from baseline 6 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Paul Foumenteze, Dr principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid in people with Metatarsalgia, run by Galderma R&D at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.