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

NCT03547817 | Completed

• 1 other identifier: SD0321063
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease; Intermittent Claudication; Lower Extremity Claudication

Outcome Measures

Primary Outcomes (1)

• Arterial blood flow

  Continuously Ultrasound Doppler measurements of the dorsalis pedis artery or tibialis posterior artery to monitor changes in arterial blood flow during 5 min sequences of intermittent negative pressure treatment. Pressure levels of 0, -10 mmHg, -20 mmHg, -40 mmHg and -60 mmHg will be tested. Systolic pressures in the arm and the ankle will be assessed before the intervention to describe the patients severity of disease.

  At time of intervention

Secondary Outcomes (1)

• Skin blood flow

  At time of intervention

Study Arms (1)

Optimal negative pulse pressure regime

EXPERIMENTAL

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.

Device: Intermittent negative pressure device

Interventions

Intermittent negative pressure device 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

Optimal negative pulse pressure regime

Eligibility Criteria

• Age: 18 Years - 96 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Otivio AS: collaborator

Study Sites (1)

Department of Vascular diseases, Oslo University Hosptital, Aker

Oslo, 0586, Norway

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonny Hisdal, PhD

  Department of Vascular diseases, Oslo University Hospital, Aker

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 6, 2018
• Study Start: May 15, 2018
• Primary Completion: September 30, 2018
• Study Completion: January 31, 2019
• Last Updated: December 4, 2019

Record last verified: 2019-12

Locations

NO (1)