Validation of Patient Reported Outcome Measures for Use in Hallux Valgus

Completed

• Conditions: Hallux Valgus

• Registration Number: NCT03846687
• Lead Sponsor: Ipsen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-30
• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-20
• Status Verified: 2020-01
• Primary Completion: 2020-01-15
• Study Completion: 2020-01-15
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive debriefing (CD) of mFFI	7 days	Face-to-face interview (approx. 25 minutes) to explore understanding and relevance of mFFI items.
Concept elicitation (CE) of mFFI	7 days	Face-to-face interview (approx. 25 minutes), using semi-structured interview guide to explore the symptoms and impact of HV.
Usability testing of mFFI	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.

Trial Locations

Locations (3)

Futuro Clinical Trials, LLC; 🇺🇸 McAllen, Texas, United States

Ankle and Foot Care Centers; 🇺🇸 Youngstown, Ohio, United States

University Foot and Ankle Institute; 🇺🇸 Santa Monica, California, United States