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Lactate Increase in Peripheral Artery Disease

Study of Transcutaneous Exercise Oxymetry, reLationship to LActates Increase in Claudication

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03266861
Acronym
STELLA
Enrollment
750
Registered
2017-08-30
Start date
2017-10-03
Completion date
2020-10-10
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Claudication, Intermittent, Peripheral Artery Disease

Brief summary

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).

Detailed description

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

Interventions

DIAGNOSTIC_TESTExercise oximetry

Sample at rest before the walking test Sample at rest 3 minutes after the end of the walking period

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \> 18 years old * Patient able to walk on a treadmill * Patient covered by the French health insurance * Patient able to understand the protocol * Patient agrees to be involve in the protocol and sign the consent form

Exclusion criteria

* Patient refuses to participate at the this protocol * Patient has a wash-out period for another clinical trial

Design outcomes

Primary

MeasureTime frameDescription
Correlation of lactate results to oximetryone and a half hourEvaluate the coefficient of correlation between the lactatemia increase from rest and the sum of the observed DROP values of all studied subjects.

Secondary

MeasureTime frameDescription
Correlation of lactate results to resting Ankle to brachial index (ABI)one and a half hourEvaluate the coefficient of correlation between the lactatemia increase from rest and the sum of the resting ABI value of all studied subjects..

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026