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

NCT03640676 | Completed

• 1 other identifier: 2018/748
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Outcome Measures

Primary Outcomes (2)

• Change in maximal walking distance

  Treadmill test

  At baseline and after 12 weeks of treatment

• Change in pain-free walking distance

  Treadmill test

  At baseline and after 12 weeks of treatment

Secondary Outcomes (4)

• Change in serum levels of markers of inflammation and endothelial dysfunction

  At baseline and after 12 weeks

• Changes in resting and maximal blood flow

  At baseline and after 12 weeks

• Changes in Ankle-Brachial Index

  At baseline and after 12 weeks

• Changes in arterial blood flow during application of INP

  At baseline and after 12 weeks

Study Arms (2)

INP -10mmHg

SHAM COMPARATOR

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

INP -40mmHg

ACTIVE COMPARATOR

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

Interventions

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.

INP -10mmHg; INP -40mmHg

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Otivio AS: collaborator

Study Sites (3)

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

Kristiansand, Norway

Location

Department of Vascular Surgery, Oslo University Hospital, Aker

Oslo, Norway

Location

Department of Vascular Surgery, St. Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

• Hoel H, Pettersen EM, Hoiseth LO, Mathiesen I, Seternes A, Seljeflot I, Hisdal J. Effects of intermittent negative pressure treatment on circulating vascular biomarkers in patients with intermittent claudication. Vasc Med. 2021 Oct;26(5):489-496. doi: 10.1177/1358863X211007933. Epub 2021 May 13.

  PMID: 33985385 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonny Hisdal, PhD

  Deprtment of Vascular Diseases, Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double-blinded randomized sham-controlled trial

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 21, 2018
• Study Start: January 14, 2019
• Primary Completion: December 23, 2019
• Study Completion: January 31, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (3)