NCT03846687

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

February 13, 2019

Last Update Submit

January 24, 2020

Conditions

Hallux Valgus

Outcome Measures

Primary Outcomes (3)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects referred by clinicians

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Foot and Ankle Institute

Santa Monica, California, 90403, United States

Location

Ankle and Foot Care Centers

Youngstown, Ohio, 22801, United States

Location

Futuro Clinical Trials, LLC

McAllen, Texas, 78501, United States

Location

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2019

First Posted

February 20, 2019

Study Start

October 30, 2018

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

US(3)