Validation of Patient Reported Outcome Measures 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).

Completed

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Key information

Conditions

Hallux Valgus Foot Deformities Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Foot and Ankle Institute, Santa Monica, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Validation of the Modified Foot Function Index (mFFI) for Use in Hallux Valgus

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Feb 20, 2019
Registry last updated: Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed