Iliac KinkingSALTY-TURTLENCT03568201
Systolic Ankle arteriaL Pressure and Transcutaneous oximetrY During a TURTLE Test in Athletes
A study testing Transcutaneous oximetry in people with Iliac Kinking, run by University Hospital, Angers at 1 site in France.
Trial summary
Aim of the study is to test the feasibility of transcutaneous oxygen pressure (TcPO2) recording in the diagnosis of iliac kinking in 20 patients with suspected of endofibrosisoriliackinking and 40 asymptomatic control heathy subjects Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Iliac Kinking
- What is being tested?
- Transcutaneous oximetry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2018to 16 Dec 2020
- 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
- Age over 18 years Insurance company affiliation Symptoms consistent with iliac kinking (patients) or absence of symptoms (controls)
Who cannot join
- Refuse to participate Exclusion period from another protocole Non affiliation to the French healthcare system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application de l'oxymétrie Dynamique et Des Index de Pression Pour le Diagnostic Des Plicatures Iliaques du Sportif
Aim of the study is to test the feasibility of transcutaneous oxygen pressure (TcPO2) recording in the diagnosis of iliac kinking in 20 patients with suspected of endofibrosisoriliackinking and 40 asymptomatic control heathy subjects
Read the detailed description
Patients suspected of PES and healthy controls after detailled explanation of the protocol will have a recording of tcpO2 on both calves and will perform a series of thigh flexion in the standing position.
- Conditions
- Iliac Kinking
- Being tested
- Transcutaneous oximetry
- Keywords
- Diagnosis, Peripheral artery disease, Sports
- Medical subject headings
- Disease, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous oximetryDiagnostic test
Measurement of TcpO2 on calves and chests. Calculation of the DROP index (decrease from rest of oxygen pressure)on both calves.
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | Patients suspected of iliac kinking will have a transcutaneous oximetry test during hip flexion Receives: Diagnostic Test: Transcutaneous oximetry |
| controls | Sham comparator | Healthy asymptomatic athletes will have a transcutaneous oximetry test during hip flexion Receives: Diagnostic Test: Transcutaneous oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a significant DROP decrease
Comparison of DROP value between PES patients and controls
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start17 Dec 2018
- Primary completion16 Dec 2020
- Study completion16 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliac KinkingStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- transcutaneous oximetry
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre Abraham, MD, PhD, Principal investigator, University hospital in Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568201
- Sponsor's protocol ID
- 2018 A01046/ 49
- Acronym
- SALTY-TURTLE
- Status last verified
- Aug 2020
- First submitted
- 13 Jun 2018
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application de l'oxymétrie Dynamique et Des Index de Pression Pour le Diagnostic Des Plicatures Iliaques du Sportif
- ClinicalTrials.gov ID
- NCT03568201
- Acronym / sponsor ID
- SALTY-TURTLE / 2018 A01046/ 49
- Conditions
- Iliac Kinking
- Keywords
- Diagnosis, Peripheral artery disease, Sports
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 16 Dec 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 26 Jun 2018 (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.
Aim of the study is to test the feasibility of transcutaneous oxygen pressure (TcPO2) recording in the diagnosis of iliac kinking in 20 patients with suspected of endofibrosisoriliackinking and 40 asymptomatic control heathy subjects
Detailed description
Patients suspected of PES and healthy controls after detailled explanation of the protocol will have a recording of tcpO2 on both calves and will perform a series of thigh flexion in the standing position.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- transcutaneous oximetry
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Diagnostic Test: Transcutaneous oximetryPatients suspected of iliac kinking will have a transcutaneous oximetry test during hip flexion |
| controls | Sham comparator | Diagnostic Test: Transcutaneous oximetryHealthy asymptomatic athletes will have a transcutaneous oximetry test during hip flexion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age over 18 years Insurance company affiliation Symptoms consistent with iliac kinking (patients) or absence of symptoms (controls)
Key exclusion criteria (1 listed)
- Refuse to participate Exclusion period from another protocole Non affiliation to the French healthcare system
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 |
|---|---|---|
| Transcutaneous oximetryMeasurement of TcpO2 on calves and chests. Calculation of the DROP index (decrease from rest of oxygen pressure)on both calves. | Diagnostic test | controls, patients |
Primary outcome
Presence of a significant DROP decrease
Time frame: 1 hour
Comparison of DROP value between PES patients and controls
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 10 Feb 2023.
- Individual participant dataSharing planned: Undecided
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.
Pierre Abraham, MD, PhD principal investigator
University hospital in Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous oximetry in people with Iliac Kinking, run by University Hospital, Angers at 1 site in France.
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 1 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 10 Feb 2023. 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 France. 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. Some participants in this study may receive a placebo. 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?
Presence of a significant DROP decrease (time frame: 1 hour). 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 10 Feb 2023.