Status:
TERMINATED
Intermittent Negative Pressure; Impact on Peripheral Artery Disease and Intermittent Claudication
Lead Sponsor:
Otivio AS
Collaborating Sponsors:
mediq Innovation Experts GmbH
Hannover Medical School
Conditions:
Peripheral Vascular Disease
Intermittent Claudication
Eligibility:
All Genders
18+ years
Phase:
NA
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 populatio...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04100681
Start Date
August 19 2019
End Date
May 31 2020
Last Update
August 25 2020
Active Locations (5)
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1
Franziskus-Krankenhaus Berlin
Berlin, Germany, 10787
2
Evangelisches Krankenhaus Hubertus, Gefäßzentrums Berlin-Brandenburg
Berlin, Germany, 14129
3
Gemeinschaftspraxis
Ettlingen, Germany, 76275
4
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, Germany, 37075