Clinical trial NCT04100681: Intermittent Negative Pressure; Impact on Peripheral Artery Disease and Intermittent Claudication
Official title: Intermittent Negative Pressure to Improve Peripheral Blood Flow in Patients With Peripheral Artery Disease and Intermittent Claudication
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Vascular Disease
Intermittent Claudication
Walking, Difficulty
Critical Limb Ischemia
Ischemia Limb
Lead sponsor: Otivio AS
Sponsor class: INDUSTRY
Collaborators: name: mediq Innovation Experts GmbH
name: Hannover Medical School
First posted: 2019-09-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multi-centre, randomized, sham (placebo) device-controlled, double-blinded trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in pain-free walking distance from baseline to week 12
timeFrame: baseline to week 12
Secondary outcomes:
measure: Change in maximal walking distance from baseline to week 12
timeFrame: 3 months treatment
measure: Change in Ankle Brachial index from baseline to week 12
timeFrame: from baseline to week 12
measure: Change in Quality of Life from baseline to week 12: EQ-5D-5L
timeFrame: from baseline to week 12
measure: Change in activity of daily living from baseline to week 12
timeFrame: from baseline to week 12
measure: Determination of compliance of subjects as assessed by the time the device has been running
timeFrame: at week 12
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Franziskus-Krankenhaus Berlin
city: Berlin
country: Germany
facility: Evangelisches Krankenhaus Hubertus, Gefäßzentrums Berlin-Brandenburg
city: Ettlingen
country: Germany
facility: Gemeinschaftspraxis
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen Georg-August-Universität
city: Mainz
country: Germany
facility: Universitätsmedizin Johannes Gutenberg Universität
Study officials:
affiliation: Gemeinschaftspraxis
name: Holger Lawall, Dr. Med
role: PRINCIPAL_INVESTIGATOR
affiliation: HCTC-KKS - Coordinating Center for Clinical Studies
name: Silke Zimmermann, Dr. rer.nat.
role: STUDY_DIRECTOR
References: