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

NCT04100681 | Terminated

• 1 other identifier: OT-FO-IC
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in maximal walking distance from baseline to week 12

  3 months treatment

• Change in Ankle Brachial index from baseline to week 12

  from baseline to week 12

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

  from baseline to week 12

• Change in activity of daily living from baseline to week 12

  from baseline to week 12

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

  at week 12

Study Arms (2)

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.

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.

Device: Sham FlowOx™ (Placebo)

Interventions

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.

Active FlowOx™

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.

Sham FlowOx™ (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Signed Informed Consent

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Otivio AS: lead
• mediq Innovation Experts GmbH: collaborator
• Hannover Medical School: collaborator

Study Sites (5)

Franziskus-Krankenhaus Berlin

Berlin, 10787, Germany

Location

Evangelisches Krankenhaus Hubertus, Gefäßzentrums Berlin-Brandenburg

Berlin, 14129, Germany

Location

Gemeinschaftspraxis

Ettlingen, 76275, Germany

Location

Universitätsmedizin Göttingen Georg-August-Universität

Göttingen, 37075, Germany

Location

Universitätsmedizin Johannes Gutenberg Universität

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases; Intermittent Claudication; Mobility Limitation; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Ischemia

Study Officials

• Holger Lawall, Dr. Med

  Gemeinschaftspraxis

  PRINCIPAL INVESTIGATOR

• Silke Zimmermann, Dr. rer.nat.

  HCTC-KKS - Coordinating Center for Clinical Studies

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 24, 2019
• Study Start: August 19, 2019
• Primary Completion: April 1, 2020
• Study Completion: May 31, 2020
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)