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Validation of Patient Reported Outcome Measures for Use in Hallux Valgus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03846687
Recruitment Status : Completed
First Posted : February 20, 2019
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
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Brief Summary:
The purpose of the study is to explore whether the mFFI is fit for purpose in adults with hallux valgus (HV).

Condition or disease
Hallux Valgus

Study Design
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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of the Modified Foot Function Index (mFFI) for Use in Hallux Valgus
Actual Study Start Date : October 30, 2018
Actual Primary Completion Date : January 15, 2020
Actual Study Completion Date : January 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bunion

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Cognitive debriefing (CD) of mFFI [ Time Frame: 7 days ]
    Face-to-face interview (approx. 25 minutes) to explore understanding and relevance of mFFI items.

  3. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects referred by clinicians
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846687


Locations
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United States, California
University Foot and Ankle Institute
Santa Monica, California, United States, 90403
United States, Ohio
Ankle and Foot Care Centers
Youngstown, Ohio, United States, 22801
United States, Texas
Futuro Clinical Trials, LLC
McAllen, Texas, United States, 78501
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
More Information
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03846687    
Other Study ID Numbers: D-FR-52120-257
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hallux Valgus
Bunion
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired