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

February 3, 2020 updated by: Jonny Hisdal, Oslo University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Kristiansand, Norway
        • Department of Surgery, Section of Vascular and Thoracic surgery, Sykehuset Sørlandet
      • Oslo, Norway
        • Department of Vascular Surgery, Oslo University Hospital, Aker
      • Trondheim, Norway
        • Department of Vascular Surgery, St. Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: INP -10mmHg
In addition to standard medical treatment, patients will receive treatment with FlowOx, applying intermittent negative pressure of -10mmHg one hour in the morning and one hour in the evening at home for 12 weeks.
Device: FlowOx
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.
Active Comparator: INP -40mmHg
In addition to standard medical treatment, patient swill receive treatment with FlowOx, applying intermittent negative pressure of -40mmHg one hour in the morning and one hour in the evening at home for 12 weeks.
Device: FlowOx
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in maximal walking distance
Time Frame: At baseline and after 12 weeks of treatment
Treadmill test
At baseline and after 12 weeks of treatment
Change in pain-free walking distance
Time Frame: At baseline and after 12 weeks of treatment
Treadmill test
At baseline and after 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline and after 12 weeks
Changes in resting and maximal blood flow
Time Frame: At baseline and after 12 weeks
Strain-gauge plethysmography
At baseline and after 12 weeks
Changes in Ankle-Brachial Index
Time Frame: At baseline and after 12 weeks
At baseline and after 12 weeks
Changes in arterial blood flow during application of INP
Time Frame: At baseline and after 12 weeks
Ultrasound
At baseline and after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Otivio AS

Investigators

  • Principal Investigator: Jonny Hisdal, PhD, Deprtment of Vascular Diseases, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2019

Primary Completion (Actual)

December 23, 2019

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

August 14, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/748

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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