Validation of Patient Reported Outcome Measures for Use in Hallux Valgus

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).

Study Overview

• Status: Completed
• Conditions: Hallux Valgus

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90403
      • University Foot and Ankle Institute
  • Ohio
    • Youngstown, Ohio, United States, 22801
      • Ankle and Foot Care Centers
  • Texas
    • McAllen, Texas, United States, 78501
      • Futuro Clinical Trials, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects referred by clinicians

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days
Cognitive debriefing (CD) of mFFI	Face-to-face interview (approx. 25 minutes) to explore understanding and relevance of mFFI items.	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.	7 days

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Hallux Valgus; Bunion
• Other Study ID Numbers: D-FR-52120-257

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No