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Automated ABPI in Peripheral Arterial Disease a Pilot Study (AUTO-PAD)

30. september 2026 oppdatert av: Hull University Teaching Hospitals NHS Trust

Assessing the Diagnostic Accuracy of AUTOmated Ankle-Brachial Pressure Index Devices Across the Spectrum of Peripheral Arterial Disease (AUTO-PAD)- A Pilot Study

The aim of this pilot study is to investigate the diagnostic accuracy of two automated ABPI devices across the spectrum of PAD (asymptomatic PAD, suspected symptomatic PAD [IC; including mild moderate and severe IC based on the Rutherford classification (21) and CLTI] and post-bypass surveillance). A second aim is to assess their useability and tolerability through semi-structured interviews with patients and clinicians. This means the research will be split into two workstreams.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

400

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Storbritannia
      • Hull, Storbritannia, HU3 2JZ
        • Rekruttering
        • Hull University Teaching Hospitals NHS Trust
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Group 1: Asymptomatic PAD:

Patients identified by the GP (PIC sites). Records screened to identify 'at risk' of PAD with >1 cardiovascular disease risk factor

Group 2: Suspected symptomatic PAD:

2a. Patients with suspected IC referred to dedicated nurse-led claudication clinic.

Group 2b. Patients with suspected CLTI referred to dedicated urgent vascular (HOT) clinic.

Group 3: Patients undergoing surveillance seen in dedicated clinics by vascular scientists

Beskrivelse

Inclusion Criteria:

Group 1: Asymptomatic

  • Adults aged 18 and over
  • At risk of PAD with ≥1 cardiovascular risk factor
  • No previous diagnosis of PAD
  • English speaking and able to understand test protocols

Group 2a: Suspected PAD (intermittent claudication)

  • Adults aged 18 and over
  • Referred and booked into the nurse-led claudication clinic due to signs/symptoms in keeping with suspected intermittent claudication
  • English speaking and able to understand test protocols

Group 2b: Suspected PAD (CLTI)

  • Adults aged 18 and over
  • Referred and booked into the vascular HOT clinic due to signs/symptoms in keeping with suspected CLTI
  • English speaking and able to understand test protocols

Group 3: Post-bypass surveillance

  • Adults aged 18 and over
  • History of lower limb bypass surgery, enrolled in and attending the local surveillance programme
  • English speaking and able to understand test protocols

Exclusion Criteria:

  • Patients who are unable to provide informed consent
  • Recent (≤4 weeks) lower-limb surgery
  • Ulcers, casts or bandages that cannot or should not be compressed
  • Patients who have had a therapeutic intervention (stent or graft) which extends to the ankle
  • Patients with known or suspected acute deep vein thrombosis (DVT) or superficial thrombophlebitis
  • Marked oedema in one or both feet
  • Inability to tolerate a supine position
  • Patients with spasms or tremors of any kind
  • Arm arteriovenous fistula
  • Inability to cooperate due to impaired cognition

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: CROSS_SECTIONAL

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Group 1 Asymptomatic

Participants with one or more CVD risk factors
Enhet: MESI mTablet

The MESI mTablet uses 3CUFFTM technology to detect pulse waveforms to assess ABPI. This involves placing a blood pressure cuff on all 4 limbs at the same time. The two arm cuffs then inflate and simultaneously measure the blood pressure in both brachial arteries. The cuff with the highest systolic pressure than reinflates with both the ankle cuffs simultaneously. The ABPI is then calculated and displayed on the tablet. A ratio of <0.9 will indicate the presence of PAD.

Enhet: BlueDop vascular Expert (BlueDopVE)

The BlueDop device is a cuffless device which comprises an egg-shaped handheld probe component and an output monitor device. The device measures mean arterial blood pressure through an algorithm. Simply, it calculates the average blood pressure based on the normal rise and fall of pressure during each heartbeat. The device then automatically generates an ankle-brachial pressure index and a corresponding traffic-light classification for each lower-limb artery, based on waveform. This output is interpreted using table 2 below. Essentially an ABPI of 0.8-1.0 with a biphasic or triphasic waveform indicates no disease whereas an ABPI <0.8 and / or a monophasic/non-specific waveform indicates the presence of PAD.
Group 2a Suspected PAD (intermittent claudication)

Partcipants presenting with Suspected PAD (intermittent claudication)
Enhet: MESI mTablet

The MESI mTablet uses 3CUFFTM technology to detect pulse waveforms to assess ABPI. This involves placing a blood pressure cuff on all 4 limbs at the same time. The two arm cuffs then inflate and simultaneously measure the blood pressure in both brachial arteries. The cuff with the highest systolic pressure than reinflates with both the ankle cuffs simultaneously. The ABPI is then calculated and displayed on the tablet. A ratio of <0.9 will indicate the presence of PAD.

Enhet: BlueDop vascular Expert (BlueDopVE)

The BlueDop device is a cuffless device which comprises an egg-shaped handheld probe component and an output monitor device. The device measures mean arterial blood pressure through an algorithm. Simply, it calculates the average blood pressure based on the normal rise and fall of pressure during each heartbeat. The device then automatically generates an ankle-brachial pressure index and a corresponding traffic-light classification for each lower-limb artery, based on waveform. This output is interpreted using table 2 below. Essentially an ABPI of 0.8-1.0 with a biphasic or triphasic waveform indicates no disease whereas an ABPI <0.8 and / or a monophasic/non-specific waveform indicates the presence of PAD.
Group 2b Suspected PAD (CLTI)

Participants presenting with tissue loss or rest pain
Enhet: MESI mTablet

The MESI mTablet uses 3CUFFTM technology to detect pulse waveforms to assess ABPI. This involves placing a blood pressure cuff on all 4 limbs at the same time. The two arm cuffs then inflate and simultaneously measure the blood pressure in both brachial arteries. The cuff with the highest systolic pressure than reinflates with both the ankle cuffs simultaneously. The ABPI is then calculated and displayed on the tablet. A ratio of <0.9 will indicate the presence of PAD.

Enhet: BlueDop vascular Expert (BlueDopVE)

The BlueDop device is a cuffless device which comprises an egg-shaped handheld probe component and an output monitor device. The device measures mean arterial blood pressure through an algorithm. Simply, it calculates the average blood pressure based on the normal rise and fall of pressure during each heartbeat. The device then automatically generates an ankle-brachial pressure index and a corresponding traffic-light classification for each lower-limb artery, based on waveform. This output is interpreted using table 2 below. Essentially an ABPI of 0.8-1.0 with a biphasic or triphasic waveform indicates no disease whereas an ABPI <0.8 and / or a monophasic/non-specific waveform indicates the presence of PAD.
Group 3 Post-bypass surveillance

Participants presenting for post-bypass surveillance
Enhet: MESI mTablet

The MESI mTablet uses 3CUFFTM technology to detect pulse waveforms to assess ABPI. This involves placing a blood pressure cuff on all 4 limbs at the same time. The two arm cuffs then inflate and simultaneously measure the blood pressure in both brachial arteries. The cuff with the highest systolic pressure than reinflates with both the ankle cuffs simultaneously. The ABPI is then calculated and displayed on the tablet. A ratio of <0.9 will indicate the presence of PAD.

Enhet: BlueDop vascular Expert (BlueDopVE)

The BlueDop device is a cuffless device which comprises an egg-shaped handheld probe component and an output monitor device. The device measures mean arterial blood pressure through an algorithm. Simply, it calculates the average blood pressure based on the normal rise and fall of pressure during each heartbeat. The device then automatically generates an ankle-brachial pressure index and a corresponding traffic-light classification for each lower-limb artery, based on waveform. This output is interpreted using table 2 below. Essentially an ABPI of 0.8-1.0 with a biphasic or triphasic waveform indicates no disease whereas an ABPI <0.8 and / or a monophasic/non-specific waveform indicates the presence of PAD.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Diagnostic Accuracy
Tidsramme: From enrolment to the end of treatment (1 day)

Diagnostic accuracy assessed via sensitivity, specificity, positive predictor value (PPV) and negative predictor value (NPV).
From enrolment to the end of treatment (1 day)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Validity assessed via correlation
Tidsramme: Data collected at enrolment (1 day)

Diagnostic performance assessed via area under the receiver operating characteristic (AUROC) curve and the assessment time difference, assessed via measurement of the time taken to perform each automated ABPI assessment and the manual ABPI assessment.
Data collected at enrolment (1 day)
Diagnostic performance
Tidsramme: Data collected at enrolment (1 day)

Assessed via area under the receiver operating characteristic (AUROC) curve.
Data collected at enrolment (1 day)
Time taken to perform each automated ABPI assessment and the manual ABPI assessment.
Tidsramme: Data collected at enrolment (1 day)

Time taken to perform each assessment in seconds
Data collected at enrolment (1 day)
Qualitative Workstream - Assessment of usability and tolerability of automated devices.
Tidsramme: Within the 2 year recruitment period

Semi structured interviews analysed using thematic analysis
Within the 2 year recruitment period
Visual Analogue Scale (VAS) score of 0-10
Tidsramme: Data collected at point of enrolment (1 day)

VAS used to assess tolerability
Data collected at point of enrolment (1 day)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hull University Teaching Hospitals NHS Trust

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. juni 2026

Primær fullføring (Antatt)

1. september 2028

Studiet fullført (Antatt)

1. september 2028

Datoer for studieregistrering

Først innsendt

14. september 2026

Først innsendt som oppfylte QC-kriteriene

24. september 2026

Først lagt ut (Faktiske)

30. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R4364

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Nei

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