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Completed

NCT Number: NCT03640676

Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease: Effects After Long-term Treatment

Studies have shown that intermittent negative pressure (INP) can induce short-term increase in blood flow in the extremity in patients with peripheral artery disease (PAD). Case reports also have indicated that INP treatment has beneficial hemodynamic and clinical effects in patients with lower limb ischemia and hard to heal leg ulcers. However, the clinical and physiological effects of long-term INP treatment are not well documented and needs further investigation.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Section of Vascular and Thoracic surgery, Sykehuset Sørlandet, Kristiansand, Norway

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About this study

A double-blinded randomized sham-controlled trial.

Otivio AS is the developer of FlowOx, a noninvasive CE marked device to increase blood flow to the lower extremity. The device acts as a pressure chamber sealed around the patient's lower leg, applying pulses of intermittent negative pressure and atmospheric pressure. The pressure pulses are generated by a control unit, alternating between removing air from- and venting the pressure chamber.

Preliminary tests indicate a significant increase in blood flow to the extremity during INP treatment at -40 mmHg, but a similar increase in blood flow was not detected during treatment INP treatment at -10 mmHg. Hence, treatment with -10 mmHg, may serve as a sham intervention, when evaluating the clinical and physiological effects of long-term INP treatment.

All patients will receive best medical treatment including advice for smoking cessation, dietary advice, and advice for physical exercise, and pharmacological treatment with statins and platelet inhibitors. Patients will be randomized into two groups, one group receiving INP treatment with a pressure of -10 mmHg, the other group receiving INP treatment with a pressure of -40 mmHg. Treatment will be conducted by the patient him/herself at home, one hour in the morning and one hour in the evening for 12 weeks.

Pain-free- and maximal walking distance, ankle-brachial index, arterial blood flow during application of INP, maximal blood flow, and biomarkers of inflammation and endothelial dysfunction will be registered at baseline and after 12 weeks to evaluate the effects of long-term INP treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ankle-Brachial Index < 0,9, and intermittent claudication

Exclusion criteria

  • Incapable to make an informed consent
  • Inability to perform a treadmill test
  • Inability to independently operate FlowOx
  • Severe heart disease such as unstable angina pectoris, severe heart failure (NYHA IV), severe valve failure
  • Severe COPD

Treatment and study plan

FlowOx

Device

FlowOx is a CE marked device developed to increase blood flow to the lower extremities. A pressure chamber is sealed around the leg below the knee and is connected to a control unit which induces pulses of 10 sec negative pressure, and 7 sec of atmospheric pressure.

Primary outcomes

  1. Change in maximal walking distance

    Time frame: At baseline and after 12 weeks of treatment

    Treadmill test

  2. Change in pain-free walking distance

    Time frame: At baseline and after 12 weeks of treatment

    Treadmill test

Secondary outcomes

  1. Change in serum levels of markers of inflammation and endothelial dysfunction

    Time frame: At baseline and after 12 weeks

    E-selectin, ICAM-I, IL1, IL-6, IL-8, TNF-alfa, TGF-beta, IL-10

  2. Changes in resting and maximal blood flow

    Time frame: At baseline and after 12 weeks

    Strain-gauge plethysmography

  3. Changes in Ankle-Brachial Index

    Time frame: At baseline and after 12 weeks

  4. Changes in arterial blood flow during application of INP

    Time frame: At baseline and after 12 weeks

    Ultrasound

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Otivio AS

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Aug 21, 2018
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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