Peripheral Vascular DiseaseFlowOxNCT04100681

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

A study testing Active FlowOx™ in people with Peripheral Vascular Disease and Intermittent Claudication, run by Otivio AS at 5 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Vascular Disease, Intermittent Claudication, Walking, Difficulty
What is being tested?: Active FlowOx™
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 5 sitesGermany
Study dates: 19 Aug 2019to 31 May 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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))

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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

Who cannot join

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)

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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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Germany5 sites

Franziskus-Krankenhaus Berlin
Berlin, 10787
Evangelisches Krankenhaus Hubertus, Gefäßzentrums Berlin-Brandenburg
Berlin, 14129
Gemeinschaftspraxis
Ettlingen, 76275
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, 37075
Universitätsmedizin Johannes Gutenberg Universität
Mainz, 55131

Other trials in Germany

About this study

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

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.

Read the 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
Being tested: Active FlowOx™, Sham FlowOx™ (Placebo)
Medical subject headings: Peripheral Vascular Diseases, Intermittent Claudication, Mobility Limitation, Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active FlowOx™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)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.

Study groups in NCT04100681
Study group	Role	What they receive
Active FlowOx™	Active comparator	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. Receives: Device: Active FlowOx™
Sham FlowOx™ (Placebo)	Sham comparator	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. Receives: Device: Sham FlowOx™ (Placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline to week 12

Secondary outcomes (5)

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.
Measured: 3 months treatment
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)
Measured: from baseline to week 12
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.
Measured: from baseline to week 12
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.
Measured: from baseline to week 12
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.
Measured: at week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Aug 201931 May 2020

First posted24 Sep 2019
Study start19 Aug 2019
Primary completion1 Apr 2020
Study completion31 May 2020

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

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A multi-centre, randomized, sham (placebo) device-controlled, double-blinded trial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04100681
Sponsor's protocol ID: OT-FO-IC
Acronym: FlowOx
Status last verified: Aug 2020
First submitted: 5 Sep 2019
Last updated: 25 Aug 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
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Placental Cells for Diabetic Foot Ulcers
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Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
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Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
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All Peripheral Vascular Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intermittent Negative Pressure to Improve Peripheral Blood Flow in Patients With Peripheral Artery Disease and Intermittent Claudication
ClinicalTrials.gov ID: NCT04100681
Acronym / sponsor ID: FlowOx / OT-FO-IC
Conditions: Peripheral Vascular Disease, Intermittent Claudication, Walking, Difficulty, Critical Limb Ischemia, Ischemia Limb
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated early due to slow recruitment and inability to recruit patients during the Covid-19 situation.
Enrolment: 16 participants (actual)
Lead sponsor: Otivio ASIndustry (pharma, biotech, devices)
Collaborators: mediq Innovation Experts GmbH, Hannover Medical School
Study start: 19 Aug 2019 (actual)
Primary completion: 1 Apr 2020 (actual)
Study completion: 31 May 2020 (actual)
First posted: 24 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: A multi-centre, randomized, sham (placebo) device-controlled, double-blinded trial

Arm	Type	Receives
Active FlowOx™	Active comparator	Device: 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.
Sham FlowOx™ (Placebo)	Sham comparator	Device: 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.:
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)).

Key exclusion criteria (20 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Active FlowOx™
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.	Device	Sham FlowOx™ (Placebo)

Primary outcome

Change in pain-free walking distance from baseline to week 12
Time frame: baseline to week 12
The change will be calculated as difference in meters and compared between the interventional and the sham group.

5 secondary outcomes

Change in maximal walking distance from baseline to week 12
Time frame: 3 months treatment
Change in Ankle Brachial index from baseline to week 12
Time frame: from baseline to week 12
Change in Quality of Life from baseline to week 12: EQ-5D-5L
Time frame: from baseline to week 12
Change in activity of daily living from baseline to week 12
Time frame: from baseline to week 12
Determination of compliance of subjects as assessed by the time the device has been running
Time frame: at week 12

Results and safety

The study was stopped early (reason given: The study was terminated early due to slow recruitment and inability to recruit patients during the Covid-19 situation.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
Individual participant dataSharing planned: No

Related trials for Peripheral Vascular Disease

RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
Not yet recruitingPhase 1
Placental Cells for Diabetic Foot Ulcers
Diabetic Foot Ulcer
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Holger Lawall, Dr. Med principal investigator

Gemeinschaftspraxis

Silke Zimmermann, Dr. rer.nat. study director

HCTC-KKS - Coordinating Center for Clinical Studies

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active FlowOx™ in people with Peripheral Vascular Disease and Intermittent Claudication, run by Otivio AS at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain-free walking distance from baseline to week 12 (time frame: baseline to week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04100681.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.