An observational study in Peripheral Artery Disease and Claudication, Intermittent, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-12.
Sponsored by University Hospital, Angers · Observational
To our knowledge, the measurement of the transcutaneous oxygen pressure during walking is the only continuous method that estimates the importance of ischemia, bilaterally and segment of limb by segment of limb. The determination of the lactates concentration, with micro method from earlobe sampling, is very widely validated in physiology and exercise physiopathology; and it is widely used, by laboratories, for exercise investigation in athletes. We use it in routine to evaluate the presence of functional limitation during tcpO2 tests on a treadmill.
The present study hypothesises a significant relationship between lactatemia variation (difference between lactatemia after 3 minutes of recovery from walking and the value at rest) and tcpO2 "decrease from rest of oxygen pressure (DROP) values for patients with peripheral artery disease (PAD).
Lactates sample (100 microliter) will be collected at rest Ankle brachial index is measured at rest transcutaneous oxygen pressure is measured at the chest, calves and buttocks and results will be expressed as the minimal value of the DROP index (Limb changes minus chest changes) Patients walk on treadmill (2MPH 10% slope) until exertional limb pain. Lactates sample (100 microliter) will be collected at minute 3 of recovery from walking Correlation of lactate increase to the sum of DROP values wil be studied
309 studies on the registry are indexed under Intermittent Claudication; 46 are open to participants now.
This study's enrollment of 750 is above the median of 100 across 58 observational studies indexed under Intermittent Claudication.
Browse Intermittent Claudication studies →University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.
Compared within Intermittent Claudication, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Peripheral Arterial Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patient with peripheral artery disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with PAD referred for treadmill testing and exercise oximetry
Diagnostic Test: Exercise oximetry
Sample at rest before the walking test Sample at rest 3 minutes after the end of the walking period
Also known as: Capillary blood sampling from the earlobe
Correlation of lactate results to oximetry
Evaluate the coefficient of correlation between the lactatemia increase from rest and the sum of the observed DROP values of all studied subjects.
Time frame: one and a half hour
Correlation of lactate results to resting Ankle to brachial index (ABI)
Evaluate the coefficient of correlation between the lactatemia increase from rest and the sum of the resting ABI value of all studied subjects..
Time frame: one and a half hour
Plan to share: Undecided
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Ran from Oct 2017 to primary completion in Oct 2020, 36 months.
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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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