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

Caen University Hospital

Status: Enrolling

Conditions: Peripheral Arterial Disease

Treatments: Diagnostic Test: transcutaneous oxygen pressure; Procedure: Supervised Exercise therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05818046

20-162

Details and patient eligibility

About

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?

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Single Group Assignment

Experimental group

Description:

intervention consiste to non-invasive arterial assessment by doppler (arterial waveform) and external oxygen probe (Transcutaneous oxygen pressure) at 3,6 and 9 weeks of supervised exercise therapy

Treatment:

Procedure: Supervised Exercise therapy

Diagnostic Test: transcutaneous oxygen pressure