Peripheral Arterial Disease Clinical Trial
— WAVESUPEXOfficial title:
Analysis of Arterial Waveforms and Oxygen Pressure During Supervised Exercise for Peripheral Artery Disease
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?
Status | Recruiting |
Enrollment | 36 |
Est. completion date | November 25, 2025 |
Est. primary completion date | May 10, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Caen Normandie | Caen | Normandie |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen |
France,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evolution of oximetry at 3 week from baseline | To describe the evolution of oximetry during SET at 3 weeks from baseline (TcPO2 leg value) | at 3 weeks | |
Secondary | 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) | at 3 weeks | |
Secondary | 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) | 6 weeks | |
Secondary | 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) | 9 weeks | |
Secondary | 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) | 12 weeks | |
Secondary | Evolution of oximetry at 6 week from baseline | To describe the evolution of oximetry during SET at 6 weeks from baseline (TcPO2 leg value) | at 6 weeks | |
Secondary | Evolution of oximetry at 9 week from baseline | To describe the evolution of oximetry during SET at 9 weeks from baseline (TcPO2 leg value) | at 9 weeks | |
Secondary | Evolution of oximetry at 12 week from baseline | To describe the evolution of oximetry during SET at 12 weeks from baseline (TcPO2 leg value) | at 12 weeks |
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