NCT03854097

Brief Summary

The study will evaluate the effect of intermittent negative pressure (INP) on peripheral arterial disease (PAD) patient vascular function and blood flow. Patients will be given either -40mmHg INP or -10mmHg INP which will act as a placebo. Healthy volunteers will be given -40mmHg INP to evaluate changes in vascular function and blood flow with INP in healthy physiology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 16, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2021

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

2.3 years

First QC Date

February 19, 2019

Last Update Submit

August 5, 2021

Conditions

Peripheral Arterial Disease

Keywords

PAD

Outcome Measures

Primary Outcomes (4)

  • Change in microvascular blood flow

    Microvascular blood flow measurement in foot using laser Dopper imaging.

    Baseline, 1 day and 4-8 weeks

  • Change in microvascular endothelial function

    Peak blood perfusion response to acetylcholine (ACh) delivered by iontophoresis will be measured using a laser Doppler imager.

    Baseline, 1 day and 4-8 weeks

  • Change in arterial stiffness

    Brachial pulse wave analysis (PWA) augmentation index (Ax) and carotid-femoral pulse wave velocity (m/s) (PWV) as an indication of arterial stiffness.

    Baseline, 1 day and 4-8 weeks

  • Change in macrovascular endothelial function

    Brachial endothelial function measured as change in brachial blood vessel diameter (%) upon shear stress.

    Baseline, 1 day and 4-8 weeks

Secondary Outcomes (3)

  • Change in pain score

    Baseline, 1 day and 4-8 weeks

  • Change in concentration of blood borne inflammatory and oxidative stress biomarkers

    Baseline, 1 day and 4-8 weeks

  • Change in Ankle-Brachial Pressure Index (ABPI)

    Baseline, 1 day and 4-8 weeks

Study Arms (3)

Active PAD group

EXPERIMENTAL

-40mmHg of Intermittent Negative Pressure (INP) for 4-8 weeks.

Device: Active Intermittent Negative Pressure (INP)

Placebo PAD group

EXPERIMENTAL

-10mmHg of Intermittent Negative Pressure (INP) for 4-8 weeks.

Device: Placebo Intermittent Negative Pressure (INP)

Healthy Volunteers

EXPERIMENTAL

-40 mmHg of Intermittent Negative Pressure (INP) for 5 days

Device: Active Intermittent Negative Pressure (INP)

Interventions

Active Intermittent Negative Pressure (INP)DEVICE

Application of -40mmHg negative pressure on the lower limb

Active PAD groupHealthy Volunteers
Placebo Intermittent Negative Pressure (INP)DEVICE

Application of -10mmHg negative pressure on the lower limb

Placebo PAD group

Eligibility Criteria

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

You may qualify if:

  • PAD Patients:
  • Age ≥ 18 years
  • Attending vascular outpatient clinics or admitted in ward with PAD.
  • ABPI \<0.9
  • Healthy Volunteers:
  • Age ≥ 18 years
  • No current or previous significant cardiovascular illness
  • Able to give written informed consent

You may not qualify if:

  • PAD Patients:
  • Unable to give written informed consent
  • Patients with deep venous thrombosis
  • Pregnant women
  • Healthy Volunteers:
  • Positive medical history of: Vascular diseases such as PAD, stroke, IHD, hypertension... etc.
  • Haematological conditions such as hypercoagulability, deep venous thrombosis... etc.,
  • Alcohol excess
  • Unable to give written informed consent
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Medicine, University of Dundee, Ninewells Hospital & Medical School

Dundee, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Jody McIntosh

    PhD student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2019

First Posted

February 26, 2019

Study Start

February 16, 2019

Primary Completion

June 5, 2021

Study Completion

June 5, 2021

Last Updated

August 6, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)