Validation of Patient Reported Outcome Measures for Use in Hallux Valgus

Hallux Valgus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03846687
• Other study ID #: D-FR-52120-257
• Status: Completed
• Start date: October 30, 2018
• Est. completion date: January 15, 2020

Study information

• Verified date: January 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bunion
• Hallux Valgus

Locations

Country	Name	City	State
United States	Futuro Clinical Trials, LLC	McAllen	Texas
United States	University Foot and Ankle Institute	Santa Monica	California
United States	Ankle and Foot Care Centers	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Cognitive debriefing (CD) of mFFI	Face-to-face interview (approx. 25 minutes) to explore understanding and relevance of mFFI items.	7 days
Primary	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