Hallux ValgusNCT03846687
Validation of Patient Reported Outcome Measures for Use in Hallux Valgus
An observational study of Hallux Valgus, run by Ipsen at 3 sites in United States.
Trial summary
The purpose of the study is to explore whether the mFFI is fit for purpose in adults with hallux valgus (HV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Oct 2018to 15 Jan 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects referred by clinicians
Who may be able to join
- Male or female, of any race and, aged ≥ 18 years
- Clinical diagnosis of hallux valgus
- Fluent in reading/speaking US-English to read and understand informed consent form and to participate in the interview
Who cannot join
- Participation in another foot-based clinical trial in the last 90 days or in Ipsen's clinical trial D-FR-52120-237
- Current chronic drug or alcohol abuse problem
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Futuro Clinical Trials, LLC
McAllen, Texas, 78501
University Foot and Ankle Institute
Santa Monica, California, 90403
Ankle and Foot Care Centers
Youngstown, Ohio, 22801
About this study
Official title: Validation of the Modified Foot Function Index (mFFI) for Use in Hallux Valgus
The purpose of the study is to explore whether the mFFI is fit for purpose in adults with hallux valgus (HV).
- Conditions
- Hallux Valgus
- Medical subject headings
- Hallux Valgus
What is being measured
The primary outcome is the main question the study is designed to answer.
Concept elicitation (CE) of mFFI
Face-to-face interview (approx. 25 minutes), using semi-structured interview guide to explore the symptoms and impact of HV.
Measured: 7 days
Cognitive debriefing (CD) of mFFI
Face-to-face interview (approx. 25 minutes) to explore understanding and relevance of mFFI items.
Measured: 7 days
Usability testing of mFFI
Telephone interview (approx. 20 minutes) using a semi-structured interview guide to explore how participants found usability of completing the mFFI daily in electronic format on their own device.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start30 Oct 2018
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by IpsenThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846687
- Sponsor's protocol ID
- D-FR-52120-257
- Status last verified
- Jan 2020
- First submitted
- 13 Feb 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Modified Foot Function Index (mFFI) for Use in Hallux Valgus
- ClinicalTrials.gov ID
- NCT03846687
- Acronym / sponsor ID
- D-FR-52120-257
- Conditions
- Hallux Valgus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 20 Feb 2019 (actual)
- 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.
The purpose of the study is to explore whether the mFFI is fit for purpose in adults with hallux valgus (HV).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects referred by clinicians
Key inclusion criteria (3 listed)
- Male or female, of any race and, aged ≥ 18 years
- Clinical diagnosis of hallux valgus
- Fluent in reading/speaking US-English to read and understand informed consent form and to participate in the interview
Key exclusion criteria (2 listed)
- Participation in another foot-based clinical trial in the last 90 days or in Ipsen's clinical trial D-FR-52120-237
- Current chronic drug or alcohol abuse problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concept elicitation (CE) of mFFI
Time frame: 7 days
Face-to-face interview (approx. 25 minutes), using semi-structured interview guide to explore the symptoms and impact of HV.
Cognitive debriefing (CD) of mFFI
Time frame: 7 days
Face-to-face interview (approx. 25 minutes) to explore understanding and relevance of mFFI items.
Usability testing of mFFI
Time frame: 7 days
Telephone interview (approx. 20 minutes) using a semi-structured interview guide to explore how participants found usability of completing the mFFI daily in electronic format on their own device.
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 27 Jan 2020.
Related trials for Hallux Valgus
Active, not recruitingPhase 2/3
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva
RecruitingObservational study
A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure
Hallux Valgus
Active, not recruiting
The Hyalex MTP Study
Hallux Valgus, Hallux Limitus
Not yet recruitingObservational study
Incidence and Risk Factors of Postoperative Chronic Pain in Patients Who Have Undergone Hallux Valgus Surgery
Postoperative Chronic Pain, Hallux Valgus Surgery
Recruiting
A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery
Hallux Valgus, Orthopedic Disorder
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.
Ipsen Medical Director study director
Ipsen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Valgus, run by Ipsen at 3 sites in United States.
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 2 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Concept elicitation (CE) of mFFI (time frame: 7 days). The study lists 3 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 27 Jan 2020.