Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease: Optimal Pulse Pressure Regime
Primary Purpose
Peripheral Artery Disease, Intermittent Claudication, Lower Extremity Claudication
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Intermittent negative pressure device
Sponsored by
About this trial
This is an interventional basic science trial for Peripheral Artery Disease
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
Sites / Locations
- Department of Vascular diseases, Oslo University Hosptital, Aker
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Optimal negative pulse pressure regime
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03547817
First Posted
May 22, 2018
Last Updated
December 3, 2019
Sponsor
Oslo University Hospital
Collaborators
Otivio AS
1. Study Identification
Unique Protocol Identification Number
NCT03547817
Brief Title
Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease: Optimal Pulse Pressure Regime
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Otivio AS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease, Intermittent Claudication, Lower Extremity Claudication
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Optimal negative pulse pressure regime
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Intermittent negative pressure device
Intervention Description
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
Primary Outcome Measure Information:
Title
Arterial blood flow
Description
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.
Time Frame
At time of intervention
Secondary Outcome Measure Information:
Title
Skin blood flow
Description
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.
Time Frame
At time of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
96 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonny Hisdal, PhD
Organizational Affiliation
Department of Vascular diseases, Oslo University Hospital, Aker
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Vascular diseases, Oslo University Hosptital, Aker
City
Oslo
ZIP/Postal Code
0586
Country
Norway
12. IPD Sharing Statement
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Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease: Optimal Pulse Pressure Regime
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