Intermittent Negative Pressure; Impact on Peripheral Artery Disease and Intermittent Claudication

NCT ID: NCT04100681

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-19
• Study Completion Date: 2020-05-31

Brief Summary

The objective is to ensure the pro-active collection of information on quality, safety and performance of FlowOx™ after it is placed on the market. The study will be carried out in a patient population with peripheral artery disease (claudicatio intermittens) to confirm its usefulness and in particular gather information for further improvements of the device related to this patient population. The data collected from the use of the CE-marked FlowOX™ device are change of walking distance, quality of life, and the patient's compliance.

Detailed Description

A multi-center, randomized, sham (placebo)-controlled, double-blind trial to assess the efficacy and safety of FlowOx. This is done by comparing the increase in pain free walking distance compared to sham (placebo) device in patients with peripheral arterial disease (PAD) and intermittent claudication.

This study is conducted to assess the efficacy and safety of FlowOx™ compared to a sham FlowOx™ (placebo) device treatment. FlowOx™ can provide intermittent negative pressure (up to - 40 mmHg INP [intermittent negative pressure]) which is known to improve blood flow. The same device will also work as a sham (placebo) device by less negative pressure exerted by the device (in the range of -10 mmHg).

Daily home use of FlowOx™ for 2 hours (divided into minimum two sessions of 1 hour) per day in PAD-patients with intermittent claudication (stage II acc.to EMA, equivalent to Fontaine stage IIb in Germany) relative to sham (placebo) will be provided over a period of 12 weeks.

This efficacy study is evaluating the clinical effects of INP on patient with intermittent claudication with special focus on changes in pain free walking distance and quality of life.

Conditions

Peripheral Vascular Disease; Intermittent Claudication; Walking, Difficulty; Critical Limb Ischemia; Ischemia Limb

Study Design

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

Study Groups

Active FlowOx™

The application of pulsating negative pressure will be up to 120 minutes long per day. The pulsating negative pressure used will be approximately 40 mm Hg alternating with ambient air pressure, the pulse consisting of 10 seconds of negative pressure followed by 7 seconds of atmospheric pressure.

Group Type: ACTIVE_COMPARATOR

Active FlowOx™

Intervention Type: DEVICE

Treatment is done by the patient at home for about 2 hours per day. Recommended to be 1 hour in the morning and 1 hour in the afternoon.

Sham FlowOx™ (Placebo)

The application of a mild pulsating negative pressure will be up to 120 minutes long. The pulsating negative pressure used will be approximately 10 mm Hg alternating with ambient air pressure, the pulse consisting of 10 seconds of negative pressure followed by 7 seconds of atmospheric pressure.

Group Type: SHAM_COMPARATOR

Sham FlowOx™ (Placebo)

Intervention Type: DEVICE

Treatment is done by the patient at home for about 2 hours per day. Recommended to be 1 hour in the morning and 1 hour in the afternoon.

Interventions

Active FlowOx™

Treatment is done by the patient at home for about 2 hours per day. Recommended to be 1 hour in the morning and 1 hour in the afternoon.

Intervention Type: DEVICE

Sham FlowOx™ (Placebo)

Treatment is done by the patient at home for about 2 hours per day. Recommended to be 1 hour in the morning and 1 hour in the afternoon.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female outpatients, age greater or equal 18 years
• Stable evidence based pAVK therapy for at least 3 months
• Ability to perform a treadmill test
• Confirmation of clinical diagnosis of PAD as objective evidence of Fontaine stage IIb PAD i.e.:

• Reduced ankle systolic blood pressure (ABI <0.9) on target leg
• Pain free walking distance < 200 m in standardized walking test (initial claudication distance (ICD))
• Completion of at least two treadmill tests within a time interval of greater or equal to 1 week prior to randomisation. Maximum change in claudication should not exceed a predefined threshold (<25% for the absolute claudication distance (ACD)).
• Intermittent claudication lasting for at least 3 months
• Stable smoking habits for at least 3 months prior to inclusion
• Signed Informed Consent

Exclusion Criteria

• PAOD-patients with critical limb ischemia (CLI), equivalent to EMA's or Fontaine's PAOD-stages III and IV
• Any kind of revascularization (endovascular, surgical) in the iliac or other leg arteries within 3 months prior to Visit 1
• Patients with polyneuropathy
• Other illnesses limiting exercise capacity (angina pectoris, heart failure, respiratory disease, orthopedic disease, neurological disorders)
• Use of confounding medications within the last 4 weeks prior the Visit 1 e.g. vasoactive compounds like Cilostazol or Naftidrofuryl
• Uncontrolled hypertension (> 180/95 mmHg) or hypotension (supine < 100 mmHg)
• Severe anemia
• Pregnancy or lactation period
• Woman with childbearing potential without an effective contraceptive method (effective contraception method: hormonal contraceptive, hormonal vaginal devices or injections with prolonged release; an intrauterine device, or a barrier method of contraception such as condom or occlusive cap with spermicide (foam/gel/film/cream/suppository)
• Planned surgical intervention requiring hospitalization during the clinical trial
• Previous inclusion in the present clinical trial or parallel participation in other clinical trials (up to 8 weeks before Visit 1)
• Incapability of understanding nature, meaning and consequences of the clinical trial
• Patient unable to read and or write
• Patients in custody by juridical or official order
• Patients, who are members of the staff of the trial centre, staff of the sponsor or involved Clinical Research Organizations (CRO's), the investigator him-/herself or close relatives of the investigator
• Patients unable to don or doff the FlowOx device (either themselves or with assistance from a helper).
• Diagnosed acute deep vein thrombosis
• Systemic infection
• Alcohol disease or drug abuse
• Malignant disease

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

Sponsors

mediq Innovation Experts GmbH

UNKNOWN

Sponsor Role: collaborator

Hannover Medical School

OTHER

Sponsor Role: collaborator

Otivio AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Holger Lawall, Dr. Med

Role: PRINCIPAL_INVESTIGATOR

Gemeinschaftspraxis

Silke Zimmermann, Dr. rer.nat.

Role: STUDY_DIRECTOR

HCTC-KKS - Coordinating Center for Clinical Studies

Locations

Franziskus-Krankenhaus Berlin

Berlin, , Germany

Evangelisches Krankenhaus Hubertus, Gefäßzentrums Berlin-Brandenburg

Berlin, , Germany

Gemeinschaftspraxis

Ettlingen, , Germany

Universitätsmedizin Göttingen Georg-August-Universität

Göttingen, , Germany

Universitätsmedizin Johannes Gutenberg Universität

Mainz, , Germany

Countries

Germany

Other Identifiers

OT-FO-IC

Identifier Type: -

Identifier Source: org_study_id