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Intermittent Negative Pressure; Impact on Peripheral Artery Disease and Intermittent Claudication (FlowOx)

Primary Purpose

Peripheral Vascular Disease, Intermittent Claudication, Walking, Difficulty

Status

Terminated

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Active FlowOx™

Sham FlowOx™ (Placebo)

About this trial

This is an interventional treatment trial for Peripheral Vascular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Franziskus-Krankenhaus Berlin
Evangelisches Krankenhaus Hubertus, Gefäßzentrums Berlin-Brandenburg
Gemeinschaftspraxis
Universitätsmedizin Göttingen Georg-August-Universität
Universitätsmedizin Johannes Gutenberg Universität

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active FlowOx™

Sham FlowOx™ (Placebo)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in pain-free walking distance from baseline to week 12

The change will be calculated as difference in meters and compared between the interventional and the sham group.

Secondary Outcome Measures

Change in maximal walking distance from baseline to week 12

The change will be calculated as difference in meters and compared between the interventional and the sham group.

Change in Ankle Brachial index from baseline to week 12

Determination of the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium)

Change in Quality of Life from baseline to week 12: EQ-5D-5L

The 5-level EQ-5D (EuroQol- 5 Dimension) version (EQ-5D-5L) essentially consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). EQ-5D-5L describes the health condition of adults in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). Patient indicate their health states by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ-VAS score is read on a scale of 0-100 points (scale name: health condition), depending on where the patient has set his mark. 0 points mean the worst possible health condition, while 100 points is the best health possible.

Change in activity of daily living from baseline to week 12

To evaluate the activity of daily living the standardized questionnaire VascuQoL-6 is used which comprises a set of 6 questions. Each question is scored 1-4. The sum of each individual question score is used to generate a "Total" Score. A higher value indicates better health status.

Determination of compliance of subjects as assessed by the time the device has been running

The FlowOx device records the time the device has been running each time it was started. This record is saved on an USB stick which is readable by the study personnel only and serves to document the patient's compliance.

Full Information

NCT ID

NCT04100681

First Posted

September 5, 2019

Last Updated

August 21, 2020

Sponsor

Otivio AS

Collaborators

mediq Innovation Experts GmbH, Hannover Medical School

1. Study Identification

Unique Protocol Identification Number

NCT04100681

Brief Title

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

Acronym

FlowOx

Official Title

Intermittent Negative Pressure to Improve Peripheral Blood Flow in Patients With Peripheral Artery Disease and Intermittent Claudication

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Terminated

Why Stopped

The study was terminated early due to slow recruitment and inability to recruit patients during the Covid-19 situation.

Study Start Date

August 19, 2019 (Actual)

Primary Completion Date

April 1, 2020 (Actual)

Study Completion Date

May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Otivio AS

Collaborators

mediq Innovation Experts GmbH, Hannover Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A multi-centre, randomized, sham (placebo) device-controlled, double-blinded trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active FlowOx™

Arm Type

Active Comparator

Arm Description

Arm Title

Sham FlowOx™ (Placebo)

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Active FlowOx™

Intervention Description

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

Intervention Name(s)

Sham FlowOx™ (Placebo)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in pain-free walking distance from baseline to week 12

Description

The change will be calculated as difference in meters and compared between the interventional and the sham group.

Time Frame

baseline to week 12

Secondary Outcome Measure Information:

Title

Change in maximal walking distance from baseline to week 12

Description

The change will be calculated as difference in meters and compared between the interventional and the sham group.

Time Frame

3 months treatment

Title

Change in Ankle Brachial index from baseline to week 12

Description

Determination of the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium)

Time Frame

from baseline to week 12

Title

Change in Quality of Life from baseline to week 12: EQ-5D-5L

Description

Time Frame

from baseline to week 12

Title

Change in activity of daily living from baseline to week 12

Description

Time Frame

from baseline to week 12

Title

Determination of compliance of subjects as assessed by the time the device has been running

Description

Time Frame

at week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Holger Lawall, Dr. Med

Organizational Affiliation

Gemeinschaftspraxis

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Silke Zimmermann, Dr. rer.nat.

Organizational Affiliation

HCTC-KKS - Coordinating Center for Clinical Studies

Official's Role

Study Director

Facility Information:

Facility Name

Franziskus-Krankenhaus Berlin

City

Berlin

ZIP/Postal Code

10787

Country

Germany

Facility Name

Evangelisches Krankenhaus Hubertus, Gefäßzentrums Berlin-Brandenburg

City

Berlin

ZIP/Postal Code

14129

Country

Germany

Facility Name

Gemeinschaftspraxis

City

Ettlingen

ZIP/Postal Code

76275

Country

Germany

Facility Name

Universitätsmedizin Göttingen Georg-August-Universität

City

Göttingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Universitätsmedizin Johannes Gutenberg Universität

City

Mainz

ZIP/Postal Code

55131

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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