Effect of Intermittent Pressure in Patients With PAD

University of Dundee

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Device: Placebo Intermittent Negative Pressure (INP); Device: Active Intermittent Negative Pressure (INP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03854097

1-014-18

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 3 patient groups

Active PAD group

Experimental group

Description:

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

Treatment:

Device: Active Intermittent Negative Pressure (INP)

Placebo PAD group

Experimental group

Description:

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

Treatment:

Device: Placebo Intermittent Negative Pressure (INP)

Healthy Volunteers

Experimental group

Description:

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

Treatment:

Device: Active Intermittent Negative Pressure (INP)