NCT05818046

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2025

Completed
Last Updated

August 30, 2023

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

February 10, 2023

Last Update Submit

August 29, 2023

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial DiseaseSupervised exercise therapyarterial waveformtranscutaneous oxygen pressure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Evolution of doppler waveform at 3 week from baseline

    at 3 weeks

  • Evolution of doppler waveform at 6 week from baseline

    6 weeks

  • Evolution of doppler waveform at 9 week from baseline

    9 weeks

  • Evolution of doppler waveform at 12 week from baseline

    12 weeks

  • Evolution of oximetry at 6 week from baseline

    at 6 weeks

  • +2 more secondary outcomes

Study Arms (1)

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

Diagnostic Test: transcutaneous oxygen pressureProcedure: Supervised Exercise therapy

Interventions

transcutaneous oxygen pressureDIAGNOSTIC_TEST

External proxe fixed to the skin and ultrasound examination.

Also known as: Doppler arterial waveform
Single Group Assignment
Supervised Exercise therapyPROCEDURE

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.

Single Group Assignment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PAD with intermittent claudication
  • SET prescribed
  • ABI \< 0.9
  • Beneficiary of French health care insurance

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Caen Normandie

Caen, Normandy, 14000, France

RECRUITING

Related Publications (6)

  • 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.

    PMID: 14227748BACKGROUND

  • 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.

    PMID: 9071198BACKGROUND

  • 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.

    PMID: 16102620BACKGROUND

  • 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.

    PMID: 28521662BACKGROUND

  • 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.

    PMID: 27840333BACKGROUND

  • 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.

    PMID: 28886620BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Blood Gas Monitoring, Transcutaneous

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

OximetryBlood Gas AnalysisBlood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHeart Function TestsDiagnostic Techniques, CardiovascularRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Central Study Contacts

Lanéelle

CONTACT

02 31 06 57 81drci-secretariat@chu-caen.fr

irection de la Recherche et de l'Innovation

CONTACT

02 31 06 57 81drci-secretariat@chu-caen.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2023

First Posted

April 18, 2023

Study Start

February 15, 2023

Primary Completion

May 10, 2025

Study Completion

November 25, 2025

Last Updated

August 30, 2023

Record last verified: 2023-02

Locations

FR(1)