Ankylosing SpondylitisNCT01833468
Functional Limitations Due To The Foot Involvement In Spondyloarthritis
An observational study of Ankylosing Spondylitis and Psoriatic Arthritis, run by Vakif Gureba Training and Research Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankylosing Spondylitis, Psoriatic Arthritis
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with SpA and foot pain
Who may be able to join
- 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
Who cannot join
- Patients who had flatfoot
- Previous foot surgery
- Any other disorder unrelated to the SpA will be excluded
About this study
Official title: FUNCTIONAL LIMITATIONS DUE TO the FOOT INVOLVEMENT IN SPONDYLOARTHRITIS
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.
Read the detailed description
SpA patients who had foot pain at least for 4 weeks and those having bilateral anteroposterior and lateral feet x-rays will be included into the study. Foot x-rays will be evaluated by a radiologist by using the spondyloarthropathy tarsal radiographic index (SpA-TRI). The foot related functional status of the patients will be determined by the Turkish version of the Foot and Ankle Outcome Score (FAOS).
- Conditions
- Ankylosing Spondylitis, Psoriatic Arthritis
- Keywords
- ankylosing spondylitis, Psoriatic arthritis, Foot, FAOS, SpA-TRI
- Medical subject headings
- Spondylitis, Ankylosing, Arthritis, Psoriatic
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vakif Gureba Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- nihal ozaras, ass.prof, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833468
- Sponsor's protocol ID
- Foot-SpA
- Status last verified
- Apr 2013
- First submitted
- 8 Apr 2013
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FUNCTIONAL LIMITATIONS DUE TO the FOOT INVOLVEMENT IN SPONDYLOARTHRITIS
- ClinicalTrials.gov ID
- NCT01833468
- Acronym / sponsor ID
- Foot-SpA
- Conditions
- Ankylosing Spondylitis, Psoriatic Arthritis
- Keywords
- ankylosing spondylitis, Psoriatic arthritis, Foot, FAOS, SpA-TRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vakif Gureba Training and Research HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
SpA patients who had foot pain at least for 4 weeks and those having bilateral anteroposterior and lateral feet x-rays will be included into the study. Foot x-rays will be evaluated by a radiologist by using the spondyloarthropathy tarsal radiographic index (SpA-TRI). The foot related functional status of the patients will be determined by the Turkish version of the Foot and Ankle Outcome Score (FAOS).
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with SpA and foot pain
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who had flatfoot
- Previous foot surgery
- Any other disorder unrelated to the SpA will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The foot-related functional status of SpA patients
Time frame: 1 month
The foot related functional status of the subjects will be measured with Foot Ankle Outcome Score (FAOS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nihal ozaras, ass.prof principal investigator
Bezmialem Vakif University
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis and Psoriatic Arthritis, run by Vakif Gureba Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The foot-related functional status of SpA patients (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2013; AzTrials last refreshed its copy on 6 Nov 2026.