Peripheral Arterial DiseaseWAVESUPEXNCT05818046
Analysis of Arterial Waveforms and Oxygen Pressure During Supervised Exercise for Peripheral Artery Disease
A study testing transcutaneous oxygen pressure and Supervised Exercise therapy in people with Peripheral Arterial Disease, run by University Hospital, Caen at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- transcutaneous oxygen pressure and Supervised Exercise therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2023to 25 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PAD with intermittent claudication
- SET prescribed
- ABI < 0.9
- Beneficiary of French health care insurance
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Caen Normandie
Caen, Normandy, 14000
Damien Lanéelle, MD
About this study
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?
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- transcutaneous oxygen pressure, Supervised Exercise therapy
- Keywords
- Peripheral Arterial Disease, Supervised exercise therapy, arterial waveform, transcutaneous oxygen pressure
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous oxygen pressureDiagnostic test
Also called Doppler arterial waveform
External proxe fixed to the skin and ultrasound examination.
Supervised Exercise therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Experimental | 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 Receives: Diagnostic Test: transcutaneous oxygen pressure; Procedure: Supervised Exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of oximetry at 3 week from baseline
To describe the evolution of oximetry during SET at 3 weeks from baseline (TcPO2 leg value)
Measured: at 3 weeks
Secondary outcomes (7)
Evolution of doppler waveform at 3 week from baseline
To describe the evolution of doppler waveform during SET at 3 weeks from baseline (SB hemodynamic classification)
Measured: at 3 weeks
Evolution of doppler waveform at 6 week from baseline
To describe the evolution of doppler waveform during SET at 6 weeks from baseline (SB hemodynamic classification)
Measured: 6 weeks
Evolution of doppler waveform at 9 week from baseline
To describe the evolution of doppler waveform during SET at 9 weeks from baseline (SB hemodynamic classification)
Measured: 9 weeks
Evolution of doppler waveform at 12 week from baseline
To describe the evolution of doppler waveform during SET at 12 weeks from baseline (SB hemodynamic classification)
Measured: 12 weeks
Evolution of oximetry at 6 week from baseline
To describe the evolution of oximetry during SET at 6 weeks from baseline (TcPO2 leg value)
Measured: at 6 weeks
Evolution of oximetry at 9 week from baseline
To describe the evolution of oximetry during SET at 9 weeks from baseline (TcPO2 leg value)
Measured: at 9 weeks
Evolution of oximetry at 12 week from baseline
To describe the evolution of oximetry during SET at 12 weeks from baseline (TcPO2 leg value)
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start15 Feb 2023
- Primary completion10 May 2025 (estimated)
- Study completion25 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818046
- Sponsor's protocol ID
- 20-162
- Acronym
- WAVESUPEX
- Status last verified
- Feb 2023
- First submitted
- 10 Feb 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
STRANDNESS DE Jr, BELL JW. AN EVALUATION OF THE HEMODYNAMIC RESPONSE OF THE CLAUDICATING EXTREMITY TO EXERCISE. Surg Gynecol Obstet. 1964 Dec;119:1237-42. No abstract available.
PubMed 14227748Gardner AW. Reliability of transcutaneous oximeter electrode heating power during exercise in patients with intermittent claudication. Angiology. 1997 Mar;48(3):229-35. doi: 10.1177/000331979704800305.
PubMed 9071198Spronk S, den Hoed PT, de Jonge LC, van Dijk LC, Pattynama PM. Value of the duplex waveform at the common femoral artery for diagnosing obstructive aortoiliac disease. J Vasc Surg. 2005 Aug;42(2):236-42; discussion 242. doi: 10.1016/j.jvs.2005.04.048.
PubMed 16102620Mahe G, Boulon C, Desormais I, Lacroix P, Bressollette L, Guilmot JL, Le Hello C, Sevestre MA, Pernod G, Constans J, Boissier C, Bura-Riviere A. Statement for Doppler waveforms analysis. Vasa. 2017 Aug;46(5):337-345. doi: 10.1024/0301-1526/a000638. Epub 2017 May 19.
PubMed 28521662Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FG, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RA, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Mar 21;135(12):e726-e779. doi: 10.1161/CIR.0000000000000471. Epub 2016 Nov 13.
PubMed 27840333Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.
PubMed 28886620
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Arterial Waveforms and Oxygen Pressure During Supervised Exercise for Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT05818046
- Acronym / sponsor ID
- WAVESUPEX / 20-162
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Arterial Disease, Supervised exercise therapy, arterial waveform, transcutaneous oxygen pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 25 Nov 2025 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | Experimental | Diagnostic Test: transcutaneous oxygen pressure, Procedure: Supervised Exercise therapyintervention 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- PAD with intermittent claudication
- SET prescribed
- ABI < 0.9
- Beneficiary of French health care insurance
Key exclusion criteria (6 listed)
- PAD with rest ischemia
- Chronic respiratory failure
- Acute decompensated disease
- Lower limb prosthesis
- Pregnant women and breastfeeding mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous oxygen pressureAlso: Doppler arterial waveformExternal proxe fixed to the skin and ultrasound examination. | Diagnostic test | Single Group Assignment |
| Supervised Exercise therapySupervised 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. | Procedure or surgery | Single Group Assignment |
Primary outcome
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)
7 secondary outcomes
Evolution of doppler waveform at 3 week from baseline
Time frame: at 3 weeks
Evolution of doppler waveform at 6 week from baseline
Time frame: 6 weeks
Evolution of doppler waveform at 9 week from baseline
Time frame: 9 weeks
Evolution of doppler waveform at 12 week from baseline
Time frame: 12 weeks
Evolution of oximetry at 6 week from baseline
Time frame: at 6 weeks
Evolution of oximetry at 9 week from baseline
Time frame: at 9 weeks
Evolution of oximetry at 12 week from baseline
Time frame: at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Background: PubMed 14227748STRANDNESS DE Jr, BELL JW. AN EVALUATION OF THE HEMODYNAMIC RESPONSE OF THE CLAUDICATING EXTREMITY TO EXERCISE. Surg Gynecol Obstet. 1964 Dec;119:1237-42. No abstract available.
- Background: PubMed 9071198Gardner AW. Reliability of transcutaneous oximeter electrode heating power during exercise in patients with intermittent claudication. Angiology. 1997 Mar;48(3):229-35. doi: 10.1177/000331979704800305.
- Background: PubMed 16102620Spronk S, den Hoed PT, de Jonge LC, van Dijk LC, Pattynama PM. Value of the duplex waveform at the common femoral artery for diagnosing obstructive aortoiliac disease. J Vasc Surg. 2005 Aug;42(2):236-42; discussion 242. doi: 10.1016/j.jvs.2005.04.048.
- Background: PubMed 28521662Mahe G, Boulon C, Desormais I, Lacroix P, Bressollette L, Guilmot JL, Le Hello C, Sevestre MA, Pernod G, Constans J, Boissier C, Bura-Riviere A. Statement for Doppler waveforms analysis. Vasa. 2017 Aug;46(5):337-345. doi: 10.1024/0301-1526/a000638. Epub 2017 May 19.
- Background: PubMed 27840333Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FG, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RA, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Mar 21;135(12):e726-e779. doi: 10.1161/CIR.0000000000000471. Epub 2016 Nov 13.
- Background: PubMed 28886620Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.
- Individual participant dataSharing planned: Undecided
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Peripheral Arterial Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous oxygen pressure and Supervised Exercise therapy in people with Peripheral Arterial Disease, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lanéelle (02 31 06 57 81, drci-secretariat@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of oximetry at 3 week from baseline (time frame: at 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05818046, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.