NCT06007469

Brief Summary

To identify a correlation between Toe Brachial pressure Index (TBPI) and Acceleration time of the pedal vessels. The aim would then to use this data to design a clinical study assessing the relationship between PAT and wound healing in patients with PAD.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2022

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 4, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2024

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

May 27, 2022

Last Update Submit

August 22, 2023

Conditions

Critical Limb IschemiaClaudication, Intermittent

Keywords

ischaemiaABPITBPIclaudicationulcerationacceleration timeduplex ultrasound

Outcome Measures

Primary Outcomes (1)

  • Foot Perfusion.

    ankle arterial acceleration time versus toe pressure (mmHg) Manual blood pressures of at the toe (mmHg) will also be measured from all participants, where technically possible.

    1 measure

Study Arms (2)

Critical Limb Threatening Ischaemia

Patients presenting with Critical Limb Threatening Ischaemia

Non-limb threatening peripheral vascular disease

Patients presenting with non-limb threatening peripheral vascular disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients will be identified who attend the vascular clinic at the Royal Liverpool Hospital. The first 30 patients with critical limb threatening ischaemia (CLTI) that are identified and consent for the study will be recruited. Similarly the first 20 patients who have symptoms suggestive of non-critical, peripheral arterial disease such as intermittent claudication will be recruited.

You may qualify if:

  • \. Male/Female 2. Adults aged 18 and above 3. Willing to provide written, informed consent 4. Referred into the vascular service with symptoms or confirmed PVD/CLTI

You may not qualify if:

  • Referral not indicative of PVD
  • Occlusion of vessels/no visible flow at the site of interest
  • Amputation of the limb
  • Tissue loss preventing assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Limb-Threatening IschemiaIntermittent ClaudicationIschemiaUlcer

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2022

First Posted

August 23, 2023

Study Start

October 4, 2023

Primary Completion

December 10, 2023

Study Completion

December 3, 2024

Last Updated

August 23, 2023

Record last verified: 2023-08