NCT03854097

Effect of Intermittent Pressure in Patients With PAD

Mechanistic Insights Into Changes in Blood Flow Following Application of Intermittent Negative Pressure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: University of Dundee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Active Intermittent Negative Pressure (INP)	Application of -40mmHg negative pressure on the lower limb
DEVICE	Placebo Intermittent Negative Pressure (INP)	Application of -10mmHg negative pressure on the lower limb

Timeline

• Start date: 2019-02-16
• Primary completion: 2021-06-05
• Completion: 2021-06-05
• First posted: 2019-02-26
• Last updated: 2021-08-06

Locations

1 site across 1 country: United Kingdom