Image

Analysis of Arterial Waveforms and Oxygen Pressure During Supervised Exercise for Peripheral Artery Disease

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

The goal of this observational study is to assess the evolution of oxygen pressure and arterial waveform during supervised exercise therapy in patients with peripheral arterial disease. The main questions it aims to answer are:

  • can a significant increase in oxygen pressure be observed at 3 weeks?
  • can a significant increase of oxygen pressure or arterial waveform be observed at 3, 6 or 9 weeks?

Description

Peripheral arterial disease (PAD) is a frequent pathology that affects more than 200 million people worldwide, more than 800,000 in France, and is mainly of atheromatous origin. The prevalence of this disease in France is estimated at 11% in people over 40 years of age, with an annual additional cost of €11,000 per patient. Supervised exercise therapy (SET) is the first-line treatment for intermittent claudication PAD for at least 3 months, although 15-20% of patients will not benefit from this therapy. Ankle-Brachial Index, the main diagnostic and monitoring tool for PAD, is not altered during SET. Transcutaneous oximetry (TcPO2) has been used for many years in the diagnosis of chronic permanent ischaemia, in the choice of amputation level and more recently in the diagnosis of proximal PAD.

No studies have investigated the evolution and predictive value of exercise TcPO2 in this context of SET. The assessment of arterial Doppler waveform using an objective classification has also never been performed in the specific context of SET. .

The goal of this observational study is to assess the evolution of oxygen pressure and arterial waveform during supervised exercise therapy in patients with peripheral arterial disease. The main questions it aims to answer are:

  • can a significant increase in oxygen pressure be observed at 3 weeks?
  • can a significant increase of oxygen pressure or arterial waveform be observed at 3, 6 or 9 weeks.

The perspective is to predict the effectiveness of SET in terms of maximum walking distance.

Eligibility

Inclusion Criteria:

  • PAD with intermittent claudication
  • SET prescribed
  • ABI < 0.9
  • Beneficiary of French health care insurance

Exclusion Criteria:

  • PAD with rest ischemia
  • Chronic respiratory failure
  • Acute decompensated disease
  • Lower limb prosthesis
  • Pregnant women and breastfeeding mothers
  • Place of residence more than 100 km from Caen University Hospital

Study details

Peripheral Arterial Disease

NCT05818046

University Hospital, Caen

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.