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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03640676
• Other study ID #: 2018/748
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2020
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 31, 2020
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Norway	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

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Otivio AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maximal walking distance	Treadmill test	At baseline and after 12 weeks of treatment
Primary	Change in pain-free walking distance	Treadmill test	At baseline and after 12 weeks of treatment
Secondary	Change in serum levels of markers of inflammation and endothelial dysfunction	E-selectin, ICAM-I, IL1, IL-6, IL-8, TNF-alfa, TGF-beta, IL-10	At baseline and after 12 weeks
Secondary	Changes in resting and maximal blood flow	Strain-gauge plethysmography	At baseline and after 12 weeks
Secondary	Changes in Ankle-Brachial Index		At baseline and after 12 weeks
Secondary	Changes in arterial blood flow during application of INP	Ultrasound	At baseline and after 12 weeks