Peripheral Arterial DiseaseNCT03640676
Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease: Effects After Long-term Treatment
A study testing FlowOx in people with Peripheral Arterial Disease and Intermittent Claudication, run by Oslo University Hospital at 3 sites in Norway.
Trial summary
Studies have shown that intermittent negative pressure (INP) can induce short-term increase in blood flow in the extremity in patients with peripheral artery disease (PAD). Case reports also have indicated that INP treatment has beneficial hemodynamic and clinical effects in patients with lower limb ischemia and hard… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Peripheral Arterial Disease, Intermittent Claudication
- What is being tested?
- FlowOx
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 3 sitesNorway
- Study dates
- 14 Jan 2019to 31 Jan 2020
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ankle-Brachial Index < 0,9, and intermittent claudication
Who cannot join
- Incapable to make an informed consent
- Inability to perform a treadmill test
- Inability to independently operate FlowOx
- Severe heart disease such as unstable angina pectoris, severe heart failure (NYHA IV), severe valve failure
- Severe COPD
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Department of Surgery, Section of Vascular and Thoracic surgery, Sykehuset Sørlandet
Kristiansand
Department of Vascular Surgery, Oslo University Hospital, Aker
Oslo
Department of Vascular Surgery, St. Olavs Hospital
Trondheim
About this study
Studies have shown that intermittent negative pressure (INP) can induce short-term increase in blood flow in the extremity in patients with peripheral artery disease (PAD). Case reports also have indicated that INP treatment has beneficial hemodynamic and clinical effects in patients with lower limb ischemia and hard to heal leg ulcers. However, the clinical and physiological effects of long-term INP treatment are not well documented and needs further investigation.
Read the detailed description
A double-blinded randomized sham-controlled trial.
Otivio AS is the developer of FlowOx, a noninvasive CE marked device to increase blood flow to the lower extremity. The device acts as a pressure chamber sealed around the patient's lower leg, applying pulses of intermittent negative pressure and atmospheric pressure. The pressure pulses are generated by a control unit, alternating between removing air from- and venting the pressure chamber.
Preliminary tests indicate a significant increase in blood flow to the extremity during INP treatment at -40 mmHg, but a similar increase in blood flow was not detected during treatment INP treatment at -10 mmHg. Hence, treatment with -10 mmHg, may serve as a sham intervention, when evaluating the clinical and physiological effects of long-term INP treatment.
All patients will receive best medical treatment including advice for smoking cessation, dietary advice, and advice for physical exercise, and pharmacological treatment with statins and platelet inhibitors. Patients will be randomized into two groups, one group receiving INP treatment with a pressure of -10 mmHg, the other group receiving INP treatment with a pressure of -40 mmHg. Treatment will be conducted by the patient him/herself at home, one hour in the morning and one hour in the evening for 12 weeks.
Pain-free- and maximal walking distance, ankle-brachial index, arterial blood flow during application of INP, maximal blood flow, and biomarkers of inflammation and endothelial dysfunction will be registered at baseline and after 12 weeks to evaluate the effects of long-term INP treatment.
- Being tested
- FlowOx
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlowOxDevice
FlowOx is a CE marked device developed to increase blood flow to the lower extremities. A pressure chamber is sealed around the leg below the knee and is connected to a control unit which induces pulses of 10 sec negative pressure, and 7 sec of atmospheric pressure.
| Study group | Role | What they receive |
|---|---|---|
| INP -10mmHg | Sham comparator | In addition to standard medical treatment, patients will receive treatment with FlowOx, applying intermittent negative pressure of -10mmHg one hour in the morning and one hour in the evening at home for 12 weeks. Receives: Device: FlowOx |
| INP -40mmHg | Active comparator | In addition to standard medical treatment, patient swill receive treatment with FlowOx, applying intermittent negative pressure of -40mmHg one hour in the morning and one hour in the evening at home for 12 weeks. Receives: Device: FlowOx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal walking distance
Treadmill test
Measured: At baseline and after 12 weeks of treatment
Change in pain-free walking distance
Treadmill test
Measured: At baseline and after 12 weeks of treatment
Secondary outcomes (4)
Change in serum levels of markers of inflammation and endothelial dysfunction
E-selectin, ICAM-I, IL1, IL-6, IL-8, TNF-alfa, TGF-beta, IL-10
Measured: At baseline and after 12 weeks
Changes in resting and maximal blood flow
Strain-gauge plethysmography
Measured: At baseline and after 12 weeks
Changes in Ankle-Brachial Index
Measured: At baseline and after 12 weeks
Changes in arterial blood flow during application of INP
Ultrasound
Measured: At baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start14 Jan 2019
- Primary completion23 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded randomized sham-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Otivio AS
- Responsible party
- Principal investigator, Jonny Hisdal, Oslo University Hospital
- Investigators
- Jonny Hisdal, PhD, Principal investigator, Deprtment of Vascular Diseases, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640676
- Sponsor's protocol ID
- 2018/748
- Status last verified
- Feb 2020
- First submitted
- 14 Aug 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoel H, Pettersen EM, Hoiseth LO, Mathiesen I, Seternes A, Seljeflot I, Hisdal J. Effects of intermittent negative pressure treatment on circulating vascular biomarkers in patients with intermittent claudication. Vasc Med. 2021 Oct;26(5):489-496. doi: 10.1177/1358863X211007933. Epub 2021 May 13.
PubMed 33985385
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease: Effects After Long-term Treatment
- ClinicalTrials.gov ID
- NCT03640676
- Acronym / sponsor ID
- 2018/748
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Otivio AS
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 21 Aug 2018 (actual)
- 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.
Studies have shown that intermittent negative pressure (INP) can induce short-term increase in blood flow in the extremity in patients with peripheral artery disease (PAD). Case reports also have indicated that INP treatment has beneficial hemodynamic and clinical effects in patients with lower limb ischemia and hard to heal leg ulcers. However, the clinical and physiological effects of long-term INP treatment are not well documented and needs further investigation.
Detailed description
A double-blinded randomized sham-controlled trial.
Otivio AS is the developer of FlowOx, a noninvasive CE marked device to increase blood flow to the lower extremity. The device acts as a pressure chamber sealed around the patient's lower leg, applying pulses of intermittent negative pressure and atmospheric pressure. The pressure pulses are generated by a control unit, alternating between removing air from- and venting the pressure chamber.
Preliminary tests indicate a significant increase in blood flow to the extremity during INP treatment at -40 mmHg, but a similar increase in blood flow was not detected during treatment INP treatment at -10 mmHg. Hence, treatment with -10 mmHg, may serve as a sham intervention, when evaluating the clinical and physiological effects of long-term INP treatment.
All patients will receive best medical treatment including advice for smoking cessation, dietary advice, and advice for physical exercise, and pharmacological treatment with statins and platelet inhibitors. Patients will be randomized into two groups, one group receiving INP treatment with a pressure of -10 mmHg, the other group receiving INP treatment with a pressure of -40 mmHg. Treatment will be conducted by the patient him/herself at home, one hour in the morning and one hour in the evening for 12 weeks.
Pain-free- and maximal walking distance, ankle-brachial index, arterial blood flow during application of INP, maximal blood flow, and biomarkers of inflammation and endothelial dysfunction will be registered at baseline and after 12 weeks to evaluate the effects of long-term INP treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-blinded randomized sham-controlled trial
| Arm | Type | Receives |
|---|---|---|
| INP -10mmHg | Sham comparator | Device: FlowOxIn addition to standard medical treatment, patients will receive treatment with FlowOx, applying intermittent negative pressure of -10mmHg one hour in the morning and one hour in the evening at home for 12 weeks. |
| INP -40mmHg | Active comparator | Device: FlowOxIn addition to standard medical treatment, patient swill receive treatment with FlowOx, applying intermittent negative pressure of -40mmHg one hour in the morning and one hour in the evening at home for 12 weeks. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ankle-Brachial Index < 0,9, and intermittent claudication
Key exclusion criteria (5 listed)
- Incapable to make an informed consent
- Inability to perform a treadmill test
- Inability to independently operate FlowOx
- Severe heart disease such as unstable angina pectoris, severe heart failure (NYHA IV), severe valve failure
- Severe COPD
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 |
|---|---|---|
| FlowOxFlowOx is a CE marked device developed to increase blood flow to the lower extremities. A pressure chamber is sealed around the leg below the knee and is connected to a control unit which induces pulses of 10 sec negative pressure, and 7 sec of atmospheric pressure. | Device | INP -10mmHg, INP -40mmHg |
Primary outcome
Change in maximal walking distance
Time frame: At baseline and after 12 weeks of treatment
Treadmill test
Change in pain-free walking distance
Time frame: At baseline and after 12 weeks of treatment
Treadmill test
4 secondary outcomes
Change in serum levels of markers of inflammation and endothelial dysfunction
Time frame: At baseline and after 12 weeks
Changes in resting and maximal blood flow
Time frame: At baseline and after 12 weeks
Changes in Ankle-Brachial Index
Time frame: At baseline and after 12 weeks
Changes in arterial blood flow during application of INP
Time frame: At baseline and after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Derived from this study: PubMed 33985385Hoel H, Pettersen EM, Hoiseth LO, Mathiesen I, Seternes A, Seljeflot I, Hisdal J. Effects of intermittent negative pressure treatment on circulating vascular biomarkers in patients with intermittent claudication. Vasc Med. 2021 Oct;26(5):489-496. doi: 10.1177/1358863X211007933. Epub 2021 May 13.
- Individual participant dataSharing planned: No
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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.
Jonny Hisdal, PhD principal investigator
Deprtment of Vascular Diseases, Oslo University Hospital
3 sites 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 Peripheral Arterial Disease and Intermittent Claudication, run by Oslo University Hospital at 3 sites 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in maximal walking distance (time frame: At baseline and after 12 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03640676, which also lists 1 linked publication.
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 5 Feb 2020.