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

August 29, 2023 updated by: University Hospital, Caen

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Normandie
      • Caen, Normandie, France, 14000
        • Recruiting
        • CHU Caen Normandie
        • Principal Investigator:
          • Damien LANEELLE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Group Assignment
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
Diagnostic test: transcutaneous oxygen pressure
External proxe fixed to the skin and ultrasound examination.
Other Names:
  • Doppler arterial waveform
Procedure: Supervised Exercise therapy
Supervised exercise therapy consists of three exercise sessions per week for 3 months, combining treadmill walking, lower limb muscle strengthening and stretching exercises. It is considered highly effective for people with leg pain related to peripheral arterial disease and has shown statistically significant improvements in maximum walking distance and quality of life parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of oximetry at 3 week from baseline
Time Frame: at 3 weeks
To describe the evolution of oximetry during SET at 3 weeks from baseline (TcPO2 leg value)
at 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of doppler waveform at 3 week from baseline
Time Frame: at 3 weeks
To describe the evolution of doppler waveform during SET at 3 weeks from baseline (SB hemodynamic classification)
at 3 weeks
Evolution of doppler waveform at 6 week from baseline
Time Frame: 6 weeks
To describe the evolution of doppler waveform during SET at 6 weeks from baseline (SB hemodynamic classification)
6 weeks
Evolution of doppler waveform at 9 week from baseline
Time Frame: 9 weeks
To describe the evolution of doppler waveform during SET at 9 weeks from baseline (SB hemodynamic classification)
9 weeks
Evolution of doppler waveform at 12 week from baseline
Time Frame: 12 weeks
To describe the evolution of doppler waveform during SET at 12 weeks from baseline (SB hemodynamic classification)
12 weeks
Evolution of oximetry at 6 week from baseline
Time Frame: at 6 weeks
To describe the evolution of oximetry during SET at 6 weeks from baseline (TcPO2 leg value)
at 6 weeks
Evolution of oximetry at 9 week from baseline
Time Frame: at 9 weeks
To describe the evolution of oximetry during SET at 9 weeks from baseline (TcPO2 leg value)
at 9 weeks
Evolution of oximetry at 12 week from baseline
Time Frame: at 12 weeks
To describe the evolution of oximetry during SET at 12 weeks from baseline (TcPO2 leg value)
at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2023

Primary Completion (Estimated)

May 10, 2025

Study Completion (Estimated)

November 25, 2025

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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