Intermittent Claudication, Lower Extremity Claudication, Peripheral Artery Disease
Conditions
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.
Interventions
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
Sponsors
Otivio AS
Oslo University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 96 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arterial blood flow | At time of intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Skin blood flow | At time of intervention | 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. |
Countries
Norway
Outcome results
None listed