Intermittent Negative Pressure; Impact on Peripheral Artery Disease and Intermittent Claudication (NCT04100681) | Clinical Trial Compass
TerminatedNot Applicable
Intermittent Negative Pressure; Impact on Peripheral Artery Disease and Intermittent Claudication
Stopped: The study was terminated early due to slow recruitment and inability to recruit patients during the Covid-19 situation.
Germany16 participantsStarted 2019-08-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* Sever…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in pain-free walking distance from baseline to week 12