Periferal Arterial Occlusive Disease, PAODNCT01893840
Effect on Blood Flow Using the FlowOx™ Device in Patients With Reduced Peripheral Circulation in the Lower Leg
A study testing FlowOx in people with Periferal Arterial Occlusive Disease, PAOD, run by Otivio AS at 1 site in Norway.
Trial summary
A study to assess the effect of negative pulsating pressure therapy on patients with impaired blood flow to the leg caused by arterial disease, to see if the FlowOx device will increase the blood flow to the leg in these patients. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Periferal Arterial Occlusive Disease, PAOD
- What is being tested?
- FlowOx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written Informed Consent
- Age 30-90 years
- Affected foot/shoe sise less than 46 (approximate foot length less than 29.5 cm)
- Patients with Peripheral Arterial Occlusive Disease (PAOD) grade 2,3 or 4, i.e.:
- Clinically verified grade 2, i.e. Intermittent Claudication:
- Ancle-Brachial Index (ABI)less than 0.9 or
Show all 21Show fewer
- Toe brachial Index (TBI) less than 0.7 or
- Ultrasound and/or CT/Magnetic Resonance (MR) angiography suggesting stenosis(es)and/or occlusion(s)
- Clinically verified grade 3, i.e. Critical Limb Ischemia (CLI):
- ABI less than 0.4 or
- Toe pressure less than 30 mmHg
- Rest pain since at least 2 weeks or
- Use of analgesics for rest pain for at least 2 weeks or
- Ultrasound and/or CT/Magnetic Resonance (MR) angiography suggesting stenosis(es)and/or occlusion(s)
- Clinically verified grade 4, i.e. CLI:
- Ischemic ulcers or gangrene/tissue loss
- ABI less than 0.4
- Toe pressure less than 30 mmHg
- Rest pain since at least 2 weeks or
- Use of analgesics for rest pain for at least 2 weeks or
- Ultrasound and/or CT/MR angiography suggesting stenosis(es)and/or occlusion(s)
Who cannot join
- Grade 1 PAOD
- Incapable of consenting voluntarily
- Fewer higher than 39 degrees Centigrade
- Severe Chronic Obstructive Pulmonary Disease (COPD)
- Severe heart disease such as unstable angina, severe heart failure and severe valve failure
- Severe Polyneurophathy
- Verified Osteomyelitis other than in the Phanlanx
- Currently treated for cancer and With a life expectancy of less than 2 years
Trial locations and contacts
1 site in 1 country.
About this study
A study to assess the effect of negative pulsating pressure therapy on patients with impaired blood flow to the leg caused by arterial disease, to see if the FlowOx device will increase the blood flow to the leg in these patients.
- Being tested
- FlowOx
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlowOxDevice
Boot-shaped pressure chamber generating pulsating negative pressure
| Study group | Role | What they receive |
|---|---|---|
| FlowOx | Experimental | 5 minutes of pulsating negative pressure (10 sek og -40mmHg/7 sek of athmospheric pressure) will be Applied to the patient's leg Receives: Device: FlowOx |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of the prescribed cycles delivered in the specified time FlowOx™-induced change in arterial leg blood flow (LBF)
This is calculated as the difference between the blood flow during the period using FlowOx™ (middle value over a period of 5 minutes) and baseline blood flow (middle value over a period of 5 prior to using FlowOx™)
Measured: up to 1 hour
Secondary outcomes (1)
Patient comfort measured by asking the patient a fixed set of questions
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periferal Arterial Occlusive Disease, PAODStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otivio AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Union, The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Jarlis Wesche, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893840
- Sponsor's protocol ID
- OT-FO-01
- Status last verified
- Oct 2013
- First submitted
- 26 Jun 2013
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Blood Flow Using the FlowOx™ Device in Patients With Reduced Peripheral Circulation in the Lower Leg
- ClinicalTrials.gov ID
- NCT01893840
- Acronym / sponsor ID
- OT-FO-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Otivio ASIndustry (pharma, biotech, devices)
- Collaborators
- European Union, The Research Council of Norway
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 9 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to assess the effect of negative pulsating pressure therapy on patients with impaired blood flow to the leg caused by arterial disease, to see if the FlowOx device will increase the blood flow to the leg in these patients.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FlowOx | Experimental | Device: FlowOx5 minutes of pulsating negative pressure (10 sek og -40mmHg/7 sek of athmospheric pressure) will be Applied to the patient's leg |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Written Informed Consent
- Age 30-90 years
- Affected foot/shoe sise less than 46 (approximate foot length less than 29.5 cm)
- Patients with Peripheral Arterial Occlusive Disease (PAOD) grade 2,3 or 4, i.e.:
Key exclusion criteria (8 listed)
- Grade 1 PAOD
- Incapable of consenting voluntarily
- Fewer higher than 39 degrees Centigrade
- Severe Chronic Obstructive Pulmonary Disease (COPD)
- Severe heart disease such as unstable angina, severe heart failure and severe valve failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlowOxBoot-shaped pressure chamber generating pulsating negative pressure | Device | FlowOx |
Primary outcome
% of the prescribed cycles delivered in the specified time FlowOx™-induced change in arterial leg blood flow (LBF)
Time frame: up to 1 hour
This is calculated as the difference between the blood flow during the period using FlowOx™ (middle value over a period of 5 minutes) and baseline blood flow (middle value over a period of 5 prior to using FlowOx™)
1 secondary outcome
Patient comfort measured by asking the patient a fixed set of questions
Time frame: up to 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
Related trials for Periferal Arterial Occlusive Disease, PAOD
Enrolling by invitation
The Stroke Aetiology and VascuLar Disease in Stroke and TIA Study - A Clinical Study Analysing the Effects on Cardiovascular Health and Disease With an Extended Investigation Into Conditions Causative of Stroke and Concomitant Cardiovascular Disease in Patients Admitted for Acute Stroke or TIA
Stroke, Acute Ischemic, Intracerebral Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jarlis Wesche, PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FlowOx in people with Periferal Arterial Occlusive Disease, PAOD, run by Otivio AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of the prescribed cycles delivered in the specified time FlowOx™-induced change in arterial leg blood flow (LBF) (time frame: up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2013.