Foot CallusNCT05509556
Talocalcaneal Angle in Calcaneal Spur Formation
An observational study of Foot Callus and Plantar Fascitis, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Calcaneal spur is one of the most common causes of chronic heel lower face pain without a traumatic cause. Obesity, sedentary life and advanced age play a role in its etiology. Mechanical overload is the main factor in the development of the disease. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Foot Callus, Plantar Fascitis
- What is being tested?
- talocalcaneal angle measurement
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Nov 2022
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with lateral radiographs of the feet admitted to the hospital
Who may be able to join
- Patients between the ages of 30-75 who applied to our outpatient clinic with the complaint of pain with pressing on the heel for at least 3 months.
- Patients with calcaneal spur detected in the lateral radiographs of the feet
Who cannot join
- Those who complain of heel pain for less than 3 months, have any rheumatological disease, have a previous history of foot and ankle fractures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bakirkorsadikonuk Training and Reseach Hospital
Istanbul, Bakırköy
Banu Aydeniz, 1, 905063573182, gulmezbanu@hotmail.com
münevver cinicioglu, 2, 902124141177, drmunevver@gmail.com
About this study
Official title: Effect Talocalcaneal Angle in Calcaneal Spur Formation
Calcaneal spur is one of the most common causes of chronic heel lower face pain without a traumatic cause. Obesity, sedentary life and advanced age play a role in its etiology. Mechanical overload is the main factor in the development of the disease. Impaired biomechanical factors in the foot cause repetitive microtraumas, traction periostitis and degenerative changes in the plantar fascia. The calcaneal spur is a result of this pathological process that creates pain. Many static radiological evaluation methods are used to evaluate the effect of foot anatomy in etiology. The talocalcaneal angle is one of them. It is the angle between the long axis of the talus and the long axis of the calcaneus. This angle shows the alignment of the back of the foot. It decreases with varus angulation of the back of the foot and increases with valgus angulation.
In this study, it was aimed to determine the place of the talocalcaneal angle values measured in the lateral radiographs of the foot in the etiology of painful calcaneal spur formation.
Read the detailed description
The study was designed retrospectively. In this study, talocalcaneal angles of patients with heel pain and epin on lateral foot radiograph will be compared with talocalcaneal angle measurements on lateral foot radiographs without epin calcanei. Measurements will be made by the same physician, 3 measurements will be made and the average value will be recorded.
It was aimed to investigate the effect of talocalcaneal angle on calcaneal spur formation.
- Conditions
- Foot Callus, Plantar Fascitis
- Being tested
- talocalcaneal angle measurement
- Keywords
- heel pain, talocalcaneal angle, calcaneal spur
- Medical subject headings
- Heel Spur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
talocalcaneal angle measurementOther
talocalcaneal angle measurement on lateral foot radiographs
| Study group | Role | What they receive |
|---|---|---|
| patients with calcaneal spur on the lateral radiograph of the foot | The group in which talocalcaneal angle measurement was performed in patients with calcaneal spurs on the lateral radiograph of the foot. Receives: Other: talocalcaneal angle measurement | |
| patients without calcaneal spur on lateral radiograph of the foot | The group in which talocalcaneal angle measurement was performed in patients without calcaneal spur on the lateral radiograph of the foot. Receives: Other: talocalcaneal angle measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
talocalcaneal measurement on patient groups and control radiographs with heel spurs in the first
On the lateral foot radiograph, the angle between the line drawn from the calcaneal tubercule to the 5th finger and the line drawn from the talus body to the calcaneal tubercule is measured.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Dec 2021
- Primary completion12 Aug 2022
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot CallusStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Banu Aydeniz, 1, Principal investigator, bakirkoy sadi konuk trainingandreseach hospital, Physical Therapy and rehabilitation departmentMunevver Cinicioglu, Study chair, bakirkoysadikonuk training and reseach hospital,Physical Therapy and rehabilitation departmentTurker suleymanoglu, Study chair, bakirkoysadikonuk training and reseach hospital,Physical Therapy and rehabilitation departmentmenekse gok, Study chair, bakirkoysadikonuk training and reseach hospital,Physical Therapy and rehabilitation departmentmeltem vural, Study chair, bakirkoysadikonuk training and reseach hospital,Physical Therapy and rehabilitation department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509556
- Sponsor's protocol ID
- 2021/141
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Talocalcaneal Angle in Calcaneal Spur Formation
- ClinicalTrials.gov ID
- NCT05509556
- Acronym / sponsor ID
- 2021/141
- Conditions
- Foot Callus, Plantar Fascitis
- Keywords
- heel pain, talocalcaneal angle, calcaneal spur
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 22 Aug 2022 (actual)
- 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.
Calcaneal spur is one of the most common causes of chronic heel lower face pain without a traumatic cause. Obesity, sedentary life and advanced age play a role in its etiology. Mechanical overload is the main factor in the development of the disease. Impaired biomechanical factors in the foot cause repetitive microtraumas, traction periostitis and degenerative changes in the plantar fascia. The calcaneal spur is a result of this pathological process that creates pain. Many static radiological evaluation methods are used to evaluate the effect of foot anatomy in etiology. The talocalcaneal angle is one of them. It is the angle between the long axis of the talus and the long axis of the calcaneus. This angle shows the alignment of the back of the foot. It decreases with varus angulation of the back of the foot and increases with valgus angulation.
In this study, it was aimed to determine the place of the talocalcaneal angle values measured in the lateral radiographs of the foot in the etiology of painful calcaneal spur formation.
Detailed description
The study was designed retrospectively. In this study, talocalcaneal angles of patients with heel pain and epin on lateral foot radiograph will be compared with talocalcaneal angle measurements on lateral foot radiographs without epin calcanei. Measurements will be made by the same physician, 3 measurements will be made and the average value will be recorded.
It was aimed to investigate the effect of talocalcaneal angle on calcaneal spur formation.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with calcaneal spur on the lateral radiograph of the foot | – | Other: talocalcaneal angle measurementThe group in which talocalcaneal angle measurement was performed in patients with calcaneal spurs on the lateral radiograph of the foot. |
| patients without calcaneal spur on lateral radiograph of the foot | – | Other: talocalcaneal angle measurementThe group in which talocalcaneal angle measurement was performed in patients without calcaneal spur on the lateral radiograph of the foot. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with lateral radiographs of the feet admitted to the hospital
Key inclusion criteria (2 listed)
- Patients between the ages of 30-75 who applied to our outpatient clinic with the complaint of pain with pressing on the heel for at least 3 months.
- Patients with calcaneal spur detected in the lateral radiographs of the feet
Key exclusion criteria (1 listed)
- Those who complain of heel pain for less than 3 months, have any rheumatological disease, have a previous history of foot and ankle fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| talocalcaneal angle measurementtalocalcaneal angle measurement on lateral foot radiographs | Other | patients with calcaneal spur on the lateral radiograph of the foot, patients without calcaneal spur on lateral radiograph of the foot |
Primary outcome
talocalcaneal measurement on patient groups and control radiographs with heel spurs in the first
Time frame: baseline
On the lateral foot radiograph, the angle between the line drawn from the calcaneal tubercule to the 5th finger and the line drawn from the talus body to the calcaneal tubercule is measured.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: No
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.
Banu Aydeniz, 1 principal investigator
bakirkoy sadi konuk trainingandreseach hospital, Physical Therapy and rehabilitation department
Munevver Cinicioglu study chair
bakirkoysadikonuk training and reseach hospital,Physical Therapy and rehabilitation department
Turker suleymanoglu study chair
bakirkoysadikonuk training and reseach hospital,Physical Therapy and rehabilitation department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foot Callus and Plantar Fascitis, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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 1 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: status not confirmed, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Banu Aydeniz, 1 (90 5063573182, gulmezbanu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
talocalcaneal measurement on patient groups and control radiographs with heel spurs in the first (time frame: baseline). 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 22 Aug 2022.