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

Critical Limb Ischemia Clinical Trial

— FlowOx  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04100681
• Other study ID #: OT-FO-IC
• Status: Terminated
• Phase: N/A
• Start date: August 19, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: August 2020
• Source: Otivio AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: May 31, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Intermittent Claudication
• Ischemia
• Ischemia Limb
• Mobility Limitation
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases
• Walking, Difficulty

Intervention

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 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.

Locations

Country	Name	City	State
Germany	Evangelisches Krankenhaus Hubertus, Gefäßzentrums Berlin-Brandenburg	Berlin
Germany	Franziskus-Krankenhaus Berlin	Berlin
Germany	Gemeinschaftspraxis	Ettlingen
Germany	Universitätsmedizin Göttingen Georg-August-Universität	Göttingen
Germany	Universitätsmedizin Johannes Gutenberg Universität	Mainz

Sponsors (3)

Lead Sponsor	Collaborator
Otivio AS	Hannover Medical School, mediq Innovation Experts GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline to week 12
Secondary	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.	3 months treatment
Secondary	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)	from baseline to week 12
Secondary	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.	from baseline to week 12
Secondary	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.	from baseline to week 12
Secondary	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.	at week 12