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

Peripheral Artery Disease Clinical Trial

Official title:

Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease. An Experimental Study to Investigate the Optimal Pulse Pressure Regime to Improve Blood Flow.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03547817
• Other study ID #: SD0321063
• Status: Completed
• Phase: N/A
• Start date: May 15, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: December 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 31, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 96 Years

Eligibility

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

Related Conditions & MeSH terms

• Intermittent Claudication
• Lower Extremity Claudication
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• 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

Locations

Country	Name	City	State
Norway	Department of Vascular diseases, Oslo University Hosptital, Aker	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Otivio AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Skin blood flow	Continuously Laser Doppler measurements from the pulp of the first toe to monitor changes in acral skin perfusion 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.	At time of intervention