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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04100681
Recruitment Status : Recruiting
First Posted : September 24, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborators:
mediq Innovation Experts GmbH
Hannover Medical School
Information provided by (Responsible Party):
Otivio AS

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.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease Intermittent Claudication Walking, Difficulty Critical Limb Ischemia Ischemia Limb Device: Active FlowOx™ Device: Sham FlowOx™ (Placebo) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A multi-centre, randomized, sham (placebo) device-controlled, double-blinded trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intermittent Negative Pressure to Improve Peripheral Blood Flow in Patients With Peripheral Artery Disease and Intermittent Claudication
Actual Study Start Date : August 19, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Device: 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.

Sham Comparator: 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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in maximal walking distance from baseline to week 12 [ Time Frame: 3 months treatment ]
    The change will be calculated as difference in meters and compared between the interventional and the sham group.

  2. Change in Ankle Brachial index from baseline to week 12 [ Time Frame: 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)

  3. Change in Quality of Life from baseline to week 12: EQ-5D-5L [ Time Frame: from baseline to week 12 ]

    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.


  4. Change in activity of daily living from baseline to week 12 [ Time Frame: 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.

  5. Determination of compliance of subjects as assessed by the time the device has been running [ Time Frame: at week 12 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04100681


Contacts
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Contact: Iacob Mathiesen, PhD +4746890416 im@otivio.com
Contact: Marina Lerch +491751931705 m.lerch@innovationexperts.de

Locations
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Germany
Franziskus-Krankenhaus Berlin Recruiting
Berlin, Germany, 10787
Contact: Angela Haertel, Dr. med.         
Evangelisches Krankenhaus Hubertus, Gefäßzentrums Berlin-Brandenburg Recruiting
Berlin, Germany, 14129
Contact: Clemens Fahrig, Dr. med.         
Gemeinschaftspraxis Recruiting
Ettlingen, Germany, 76275
Contact: Holger Lawall, Dr. Med         
Universitätsmedizin Göttingen Georg-August-Universität Recruiting
Göttingen, Germany, 37075
Contact: Florian Elger, MD         
Universitätsmedizin Johannes Gutenberg Universität Not yet recruiting
Mainz, Germany, 55131
Contact: Chrisitne Espinola-Klein, Dr. Med         
Sponsors and Collaborators
Otivio AS
mediq Innovation Experts GmbH
Hannover Medical School
Investigators
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Principal Investigator: Holger Lawall, Dr. Med Gemeinschaftspraxis
Study Director: Silke Zimmermann, Dr. rer.nat. HCTC-KKS - Coordinating Center for Clinical Studies

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Responsible Party: Otivio AS
ClinicalTrials.gov Identifier: NCT04100681    
Other Study ID Numbers: OT-FO-IC
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Arterial Disease
Intermittent Claudication
Peripheral Vascular Diseases
Ischemia
Mobility Limitation
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Signs and Symptoms