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Completed

NCT Number: NCT03266861

Lactate Increase in Peripheral Artery Disease

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).

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Claudication, Intermittent Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier universitaire

Angers, 49933, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise oximetry

Diagnostic Test

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

Other names: Capillary blood sampling from the earlobe

Primary outcomes

  1. Correlation of lactate results to oximetry

    Time frame: one and a half hour

    Evaluate the coefficient of correlation between the lactatemia increase from rest and the sum of the observed DROP values of all studied subjects.

Secondary outcomes

  1. Correlation of lactate results to resting Ankle to brachial index (ABI)

    Time frame: one and a half hour

    Evaluate the coefficient of correlation between the lactatemia increase from rest and the sum of the resting ABI value of all studied subjects..

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: STELLA

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 30, 2017
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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