Foot DiseaseNCT00719004
Sonographic Features of Normal Soft Tissues of the Feet
A study testing Ultrasound of the foot in people with Foot Disease and Healthy, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to study normal sonographic(ultrasound)anatomy of the soft tissues of the foot in normal volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Foot Disease, Healthy
- What is being tested?
- Ultrasound of the foot
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jan 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- no disease or abnormality of the feet
Who cannot join
- abnormality of the feet
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
About this study
The purpose of this study is to study normal sonographic(ultrasound)anatomy of the soft tissues of the foot in normal volunteers.
Read the detailed description
To study normal sonographic anatomy of soft tissues of the foot [which include Extensor retinaculum, sinus tarsi, ligaments and tendons, spring ligament and their attachments to underlying bones] in asymptomatic individuals/volunteers.
- Conditions
- Foot Disease, Healthy
- Being tested
- Ultrasound of the foot
- Keywords
- Anatomy, Foot, Sonography, Medical
- Medical subject headings
- Foot Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound of the footProcedure or surgery
These volunteers will have one ultrasound scan of each foot
| Study group | Role | What they receive |
|---|---|---|
| Normals | Experimental | Normal volunteers having Ultrasound scan of foot. Receives: Procedure: Ultrasound of the foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical relevance of understanding the anatomy will help in early and accurate identification of pathology.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gandikota Girish, MD, University of Michigan
- Investigators
- Gandikota Girish, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719004
- Sponsor's protocol ID
- HUM00007286
- Status last verified
- Apr 2016
- First submitted
- 18 Jul 2008
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Features of Normal Soft Tissues of the Feet
- ClinicalTrials.gov ID
- NCT00719004
- Acronym / sponsor ID
- HUM00007286
- Conditions
- Foot Disease, Healthy
- Keywords
- Anatomy, Foot, Sonography, Medical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 21 Jul 2008 (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.
The purpose of this study is to study normal sonographic(ultrasound)anatomy of the soft tissues of the foot in normal volunteers.
Detailed description
To study normal sonographic anatomy of soft tissues of the foot [which include Extensor retinaculum, sinus tarsi, ligaments and tendons, spring ligament and their attachments to underlying bones] in asymptomatic individuals/volunteers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normals | Experimental | Procedure: Ultrasound of the footNormal volunteers having Ultrasound scan of foot. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age and older
- no disease or abnormality of the feet
Key exclusion criteria (1 listed)
- abnormality of the feet
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 |
|---|---|---|
| Ultrasound of the footThese volunteers will have one ultrasound scan of each foot | Procedure or surgery | Normals |
Primary outcome
Clinical relevance of understanding the anatomy will help in early and accurate identification of pathology.
Time frame: 1 year
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 7 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Gandikota Girish, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound of the foot in people with Foot Disease and Healthy, run by University of Michigan at 1 site in United States.
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: finished, as of the sponsor's last update on 7 Apr 2016. 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 United States. 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?
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?
Clinical relevance of understanding the anatomy will help in early and accurate identification of pathology. (time frame: 1 year). 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 7 Apr 2016.