Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease: Optimal Pulse Pressure Regime

NCT ID: NCT03547817

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-15
• Study Completion Date: 2019-01-31

Brief Summary

Recent studies have shown that applying intermittent negative pressure (INP) with short negative pressure (-40 mmHg) pulses to the lower extremities increase arterial blood flow velocity and skin blood flow. However, the optimal magnitude of negative pressure to improve blood flow is not known, and needs further investigation. Peripheral arterial blood flow velocity, skin blood flow and skin temperature in the foot will be recorded at different levels of oscillating negative pressure to identify a pressure range which is practically, while at the same time induce clinically relevant changes in blood flow parameters. Heart rate and blood pressure will be recorded to monitor the effects on the central circulation.

Detailed Description

Cross sectional study design. The equipment for physiological measurements will be attached to the patient, and the foot will then be placed in the pressure chamber. The device induces pulses of 10 sec negative pressure, and 7 sec of atmospheric pressure. Pressure levels of 0 mmHg, -10mmHg, -20 mmHg, -40 mmHg and -60 mmHg will be tested.

Patients will be recruited from the out-patient clinic at Department of Vascular Surgery, Oslo University Hospital, Aker.

Inclusion criteria:

Diagnosed peripheral artery disease (PAD), Ankle-Brachial Index <0.9 Outcome measures:

Arterial blood flow: Ultrasound Doppler from peripheral arteries in the foot.

Skin blood flow: Laser Doppler to measure acral skin blood perfusion.

Skin temperature

Systemic blood pressure: Finger arterial pressure will continuously be acquired by a photoplethysmographic pressure recording device (Finometer).

Ankle brachial index

Pressure recordings inside the pressure chamber: Continuously monitoring of pressure within the pressure chamber using a digital differential manometer.

Conditions

Peripheral Artery Disease; Intermittent Claudication; Lower Extremity Claudication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Optimal negative pulse pressure regime

The equipment for physiological measurements will be attached to the patient, and the foot will then be placed in the pressure chamber of the intermittent negative pressure device. The device induces pulses of 10 sec negative pressure, and 7 sec of atmospheric pressure. Pressure levels of 0 mmHg, -10 mmHg, -20 mmHg, -40 mmHg and -60 mmHg will be tested, with washout periods of 5 minutes between the different pressure levels. The order of the different negative pressure levels will be randomized to avoid causal interference.

Group Type: EXPERIMENTAL

Intermittent negative pressure device

Intervention Type: DEVICE

Pressure levels of 0 mmHg, -10 mmHg, -20 mmHg, -40 mmHg and -60 mmHg will be tested, with washout periods of 5 minutes between the different pressure levels

Interventions

Intermittent negative pressure device

Pressure levels of 0 mmHg, -10 mmHg, -20 mmHg, -40 mmHg and -60 mmHg will be tested, with washout periods of 5 minutes between the different pressure levels

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosed peripheral artery disease
• Ankle-Brachial Index <0.9

Exclusion Criteria

• Incapable to make an informed consent
• Diagnosis of severe psychiatric disease
• Severe heart disease such as unstable angina pectoris, severe heart failure (NYHA IV), severe valve failure
• Systemic infection
• Use of vasoactive substances

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 96 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otivio AS

INDUSTRY

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jonny Hisdal

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonny Hisdal, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Vascular diseases, Oslo University Hospital, Aker

Locations

Department of Vascular diseases, Oslo University Hosptital, Aker

Oslo, , Norway

Countries

Norway

Other Identifiers

SD0321063

Identifier Type: -

Identifier Source: org_study_id