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

Primary Purpose

Peripheral Arterial Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transcutaneous oxygen pressure
Supervised Exercise therapy
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Peripheral Arterial Disease focused on measuring Peripheral Arterial Disease, Supervised exercise therapy, arterial waveform, transcutaneous oxygen pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Caen NormandieRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Group Assignment

Arm 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

Outcomes

Primary Outcome Measures

Evolution of oximetry at 3 week from baseline
To describe the evolution of oximetry during SET at 3 weeks from baseline (TcPO2 leg value)

Secondary Outcome Measures

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)
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)
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)
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)
Evolution of oximetry at 6 week from baseline
To describe the evolution of oximetry during SET at 6 weeks from baseline (TcPO2 leg value)
Evolution of oximetry at 9 week from baseline
To describe the evolution of oximetry during SET at 9 weeks from baseline (TcPO2 leg value)
Evolution of oximetry at 12 week from baseline
To describe the evolution of oximetry during SET at 12 weeks from baseline (TcPO2 leg value)

Full Information

First Posted
February 10, 2023
Last Updated
August 29, 2023
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT05818046
Brief Title
Analysis of Arterial Waveforms and Oxygen Pressure During Supervised Exercise for Peripheral Artery Disease
Acronym
WAVESUPEX
Official Title
Analysis of Arterial Waveforms and Oxygen Pressure During Supervised Exercise for Peripheral Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
May 10, 2025 (Anticipated)
Study Completion Date
November 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Peripheral Arterial Disease, Supervised exercise therapy, arterial waveform, transcutaneous oxygen pressure

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Group Assignment
Arm Type
Experimental
Arm 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
Intervention Type
Diagnostic Test
Intervention Name(s)
transcutaneous oxygen pressure
Other Intervention Name(s)
Doppler arterial waveform
Intervention Description
External proxe fixed to the skin and ultrasound examination.
Intervention Type
Procedure
Intervention Name(s)
Supervised Exercise therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evolution of oximetry at 3 week from baseline
Description
To describe the evolution of oximetry during SET at 3 weeks from baseline (TcPO2 leg value)
Time Frame
at 3 weeks
Secondary Outcome Measure Information:
Title
Evolution of doppler waveform at 3 week from baseline
Description
To describe the evolution of doppler waveform during SET at 3 weeks from baseline (SB hemodynamic classification)
Time Frame
at 3 weeks
Title
Evolution of doppler waveform at 6 week from baseline
Description
To describe the evolution of doppler waveform during SET at 6 weeks from baseline (SB hemodynamic classification)
Time Frame
6 weeks
Title
Evolution of doppler waveform at 9 week from baseline
Description
To describe the evolution of doppler waveform during SET at 9 weeks from baseline (SB hemodynamic classification)
Time Frame
9 weeks
Title
Evolution of doppler waveform at 12 week from baseline
Description
To describe the evolution of doppler waveform during SET at 12 weeks from baseline (SB hemodynamic classification)
Time Frame
12 weeks
Title
Evolution of oximetry at 6 week from baseline
Description
To describe the evolution of oximetry during SET at 6 weeks from baseline (TcPO2 leg value)
Time Frame
at 6 weeks
Title
Evolution of oximetry at 9 week from baseline
Description
To describe the evolution of oximetry during SET at 9 weeks from baseline (TcPO2 leg value)
Time Frame
at 9 weeks
Title
Evolution of oximetry at 12 week from baseline
Description
To describe the evolution of oximetry during SET at 12 weeks from baseline (TcPO2 leg value)
Time Frame
at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lanéelle
Phone
02 31 06 57 81
Email
drci-secretariat@chu-caen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
irection de la Recherche et de l'Innovation
Phone
02 31 06 57 81
Email
drci-secretariat@chu-caen.fr
Facility Information:
Facility Name
CHU Caen Normandie
City
Caen
State/Province
Normandie
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien Lanéelle, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
14227748
Citation
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.
Results Reference
background
PubMed Identifier
9071198
Citation
Gardner 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.
Results Reference
background
PubMed Identifier
16102620
Citation
Spronk 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.
Results Reference
background
PubMed Identifier
28521662
Citation
Mahe 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.
Results Reference
background
PubMed Identifier
27840333
Citation
Gerhard-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. Erratum In: Circulation. 2017 Mar 21;135(12 ):e791-e792.
Results Reference
background
PubMed Identifier
28886620
Citation
Aboyans 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.
Results Reference
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Analysis of Arterial Waveforms and Oxygen Pressure During Supervised Exercise for Peripheral Artery Disease

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