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

NCT ID: NCT03640676

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-14
• Study Completion Date: 2020-01-31

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.

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.

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

FlowOx

Intervention Type: 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 -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.

Group Type: ACTIVE_COMPARATOR

FlowOx

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otivio AS

INDUSTRY

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jonny Hisdal

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonny Hisdal, PhD

Role: PRINCIPAL_INVESTIGATOR

Deprtment of Vascular Diseases, Oslo University Hospital

Locations

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

Kristiansand, , Norway

Department of Vascular Surgery, Oslo University Hospital, Aker

Oslo, , Norway

Department of Vascular Surgery, St. Olavs Hospital

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 33985385 (View on PubMed)

Other Identifiers

2018/748

Identifier Type: -

Identifier Source: org_study_id