NCT01833468

Brief Summary

Seronegative spondyloarthritis (SpA) is a group of rheumatic diseases Foot involvement of the SpA is common and enthesitis, erosive changes or ankylosis are the frequent lesions. The functional status of the SpA patients are usually evaluated globally.The aim of this study is to assess specifically the foot -related functional limitations of the SpA patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2013

Shorter than P25 for all trials

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

February 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

2 months

First QC Date

April 8, 2013

Last Update Submit

April 16, 2013

Conditions

Ankylosing SpondylitisPsoriatic Arthritis

Keywords

ankylosing spondylitisPsoriatic arthritisFootFAOSSpA-TRI

Outcome Measures

Primary Outcomes (1)

  • The foot-related functional status of SpA patients

    The foot related functional status of the subjects will be measured with Foot Ankle Outcome Score (FAOS)

    1 month

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with SpA and foot pain

You may qualify if:

  • SpA patients who had foot pain at least for 4 weeks
  • Those having bilateral anteroposterior and lateral feet x-rays will be included into the study

You may not qualify if:

  • Patients who had flatfoot
  • Previous foot surgery
  • Any other disorder unrelated to the SpA will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spondylitis, AnkylosingArthritis, Psoriatic

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • nihal ozaras, ass.prof

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2013

First Posted

April 16, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 17, 2013

Record last verified: 2013-04