Effect of Intermittent Pressure in Patients With PAD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-16

Study Completion Date

2021-06-05

Brief Summary

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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.

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Detailed Description

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Atherosclerosis occurs when blood supply to the lower limbs is restricted upon accumulation of fat in the arteries. Atheroslerosis in the lower limbs is termed peripheral arterial disease (PAD). The initial symptom is pain in the lower limbs followed by ulceration and gangrene. The literature has indicated that intermittent negative pressure (INP) can be used to reduce pain and facilitate wound healing. INP is a non-invasive technique that aims to increase arterial and skin blood flow in lower limbs and foot. This study aims to investigate the underlying mechanisms that are involved in changes in blood flow following application of INP. The Flow-Ox 'boot' will be used to apply INP for periods ranging from 4-8 weeks, for an hour twice per day, to the lower limb to determine the effects of INP on vascular function and blood flow. Specifically, vascular tests such as assessments of endothelial function, arterial stiffness, ankle-brachial pressure index (ABPI) and blood borne metabolic and inflammatory markers will be performed before and after INP application. A pain chart will be employed before and after INP application to determine whether there is any change in perception of pain felt by individuals who suffer from pain associated with lower limb arterial disease.

Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Active PAD group

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

Group Type EXPERIMENTAL

Active Intermittent Negative Pressure (INP)

Intervention Type DEVICE

Application of -40mmHg negative pressure on the lower limb

Placebo PAD group

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

Group Type EXPERIMENTAL

Placebo Intermittent Negative Pressure (INP)

Intervention Type DEVICE

Application of -10mmHg negative pressure on the lower limb

Healthy Volunteers

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

Group Type EXPERIMENTAL

Active Intermittent Negative Pressure (INP)

Intervention Type DEVICE

Application of -40mmHg negative pressure on the lower limb

Interventions

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Active Intermittent Negative Pressure (INP)

Application of -40mmHg negative pressure on the lower limb

Intervention Type DEVICE

Placebo Intermittent Negative Pressure (INP)

Application of -10mmHg negative pressure on the lower limb

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes