Renal DiseaseNCT02622308
The Effects of INP on Peripheral Circulation in Dialysis Patients and Patients With PAD and Leg Ulcers
A study testing FlowOx™ in people with Renal Disease and Peripheral Arterial Disease, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This experimental study will look at the effects of INP therapy for two patient groups: 1) patients with reduced peripheral circulation and chronic wounds in patients with renal disease (dialysis patients); 2) and peripheral arterial disease and leg ulcers. Read more about this study
- Who is it for?
- Ages 18 to 96 years
- Conditions the study is for
- Renal Disease, Peripheral Arterial Disease, Arterial Leg Ulcers
- What is being tested?
- FlowOx™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteNorway
- Study dates
- 11 Mar 2016to 7 Dec 2016
- 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 96 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide informed consent
- Age: 18-96 years
- Affected foot/shoe size <46 (approximate foot length< 29,5 cm)
- Receiving hemodialysis ≥3 times per week for 1 hour per treatment OR
- Peripheral arterial disease and leg ulcer
Who cannot join
- Incapable to consent voluntarily, i.e. patients who are not able to consent due to their mental status, or who are not willing or able to perform the negative pressure therapy in a sitting position
- Not adhering to the INP therapy program
- Patients with an expected life-span less than 3 months
- Patients in whom the remaining limb is non-functional, for example due to previous stroke
- Patients in which a deep venous thrombosis or pulmonary embolism is suspected
- Limbs with uncontrolled infection
- Previous lumbar sympathectomy
- Bilateral amputation of lower extremity
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital - Ullevål, Department of Nephrology
Oslo, Oslo
About this study
Official title: The Effects of Intermittent Negative Pressure on Peripheral Circulation in Dialysis Patients and Patients With Lower Limb Ischemia and Leg Ulcers
This experimental study will look at the effects of INP therapy for two patient groups: 1) patients with reduced peripheral circulation and chronic wounds in patients with renal disease (dialysis patients); 2) and peripheral arterial disease and leg ulcers. The project is designed as a non-randomized clinical trial with single-subject multiple baseline design. Also the intervention will be subjected on the same leg for each individual throughout the study period. The other leg will act as a control. A baseline measure with patient history collection will be performed before a four-week intervention period. These measures include: Segmental pulse-volume-recording, Segmental skin perfusion pressure with a laser Doppler sensor and a pressure cuff to evaluate reactive hyperemia (Sensilase, Väsamed) and a health survey (SF-12/EQ-5D-5L) or similar. After four weeks and eight weeks of intervention, the same tests will be repeated. A final follow-up test will be two weeks after cessation of the intermittent negative pressure intervention. The study will look at the effect of INP on renal failure patients who are given dialysis at a dialysis center located at Oslo University Hospital, Ullevål. Otivio AS has supplied the FlowOx devices and provided the necessary training to perform this project. Outcome variables assessed before, during and after the 10-week study period will be: wound healing, quality of life, skin perfusion pressure and segmental pulse-volume recording. The aim of this project is to prospectively examine and elucidate the effect of intermittent negative pressure therapy on clinically relevant measures related to the reduction of peripheral macro- and microcirculation in patients with renal failure undergoing dialysis treatment.
The hypothesis of the study is:
- Application of INP in patients with renal failure, by the use of the FlowOx™ device, will improve wound healing and peripheral circulation in the foot compared to before treatment (baseline) in patients undergoing dialysis treatment.
- Application of INP in patients with PAD, by the use of the FlowOx™ device, will improve macro- and microcirculation and wound healing in the foot compared to before treatment (baseline) in patients with chronic wounds.
- Being tested
- FlowOx™
- Keywords
- Arterial leg ulcers, Intermittent Negative Pressure, Peripheral Circulation, Wound healing, Peripheral blood flow
- Medical subject headings
- Kidney Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlowOx™Device
Also called Intermittent negative pressure device
FlowOx™ uses intermittent negative and atmospheric pressure, and is intended for use as an adjunct non-invasive therapy for the treatment of reduced peripheral circulation. Negative pressure cycles are created by alternating between removing air and venting the vacuum-chamber to atmospheric pressure. The vacuum cycle is controlled by the Control Unit (Pump). FlowOx™ is designed to assists wound healing indirectly by improving blood flow to the affected limb and augmenting the wound healing effect of the contact dressings and any associated medication. Treatment is planned to be applied while the participants are seated and it does not interfere with other activities normally enjoyed while seated. Treatment is recommended for one to two hours per session aiming to improve blood flow in the affected area and thus the clinical outcomes.
| Study group | Role | What they receive |
|---|---|---|
| single-case design | Experimental | The study design will be a non-randomized clinical trial with single-subject baseline design (also called single-case baseline design) where each patients act as their own controls:
Observations (A) will be taken before and after a 8-week intervention period. We plan to introduce a 4-week INP-treatment period ('FlowOx™) (B) using the same outcome variables that were used as baseline measures. If the patient demonstrates improvements in outcome variables after the first treatment period (B1), the patient will be asked to continue INP therapy for another 4-week period, before a final assessment after a total of 8-week intervention period (B2) (A-B-B design). Receives: Device: FlowOx™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Segmental Skin Perfusion Pressure
Fully automated and quantitative evaluation of microcirculatory perfusion in the skin of the foot and leg (Sensilase, Vasamed, USA).
Multiple levels can be assessed on limbs; bilateral measurement helps to manage test time Not susceptible to interference effects from medial calcification Requires use of pressure cuffs to occlude blood flow for specified time period in order to evaluate reactive hyperemic response to controlled release of pressure Graphical output of pressure and perfusion during cuff deflation indicates the pressure (mmHg) at which skin perfusion is found to return in addition to pressure contour
Measured: 8 weeks
Life Quality (SF-12 or EQ-5D-5L)
SF-12 or EQ-5D-5L
Measured: 8 weeks
Pulse Volume Recording / segmental volume plethysmography (PVR)
PVR shows variations in the volume of blood passing through a limb during each cardiac cycle. The instrument that will be used to measure PVR for this study is Sensilase (Vasamed, USA) OR MacroLab (STR Teknikk, strteknikk.no, Aalesund, Norway).
Multiple levels can be assessed on limbs. The measures are not susceptible to interference effects from medial calcification.
Measured: 8 weeks
Wound healing (Measuring wound diameter and length)
Measurement of healing to provide a means by which progress over time to wound closure can be identified. A wound nurse will take pictures at study start and at follow-up.
Measured: 8 weeks
Ankle-Brachial Pressure Index (ABPI)
The ratio of the blood pressure at the ankle (dorsal pedis artery/posterior tibial artery) to the blood pressure in the upper arm (brachial artery)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study start11 Mar 2016
- Primary completion11 Apr 2016
- Study completion7 Dec 2016
Why it stopped: Terminated due to lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Otivio AS, University of Oslo
- Responsible party
- Principal investigator, Jonny Hisdal, Oslo University Hospital
- Investigators
- Jonny Hisdal, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622308
- Sponsor's protocol ID
- 2015/1318
- Status last verified
- Aug 2016
- First submitted
- 2 Dec 2015
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intermittent Negative Pressure on Peripheral Circulation in Dialysis Patients and Patients With Lower Limb Ischemia and Leg Ulcers
- ClinicalTrials.gov ID
- NCT02622308
- Acronym / sponsor ID
- 2015/1318
- Keywords
- Arterial leg ulcers, Intermittent Negative Pressure, Peripheral Circulation, Wound healing, Peripheral blood flow
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to lack of recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Otivio AS, University of Oslo
- Study start
- 11 Mar 2016 (actual)
- Primary completion
- 11 Apr 2016 (actual)
- Study completion
- 7 Dec 2016 (actual)
- First posted
- 4 Dec 2015 (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.
This experimental study will look at the effects of INP therapy for two patient groups: 1) patients with reduced peripheral circulation and chronic wounds in patients with renal disease (dialysis patients); 2) and peripheral arterial disease and leg ulcers. The project is designed as a non-randomized clinical trial with single-subject multiple baseline design. Also the intervention will be subjected on the same leg for each individual throughout the study period. The other leg will act as a control. A baseline measure with patient history collection will be performed before a four-week intervention period. These measures include: Segmental pulse-volume-recording, Segmental skin perfusion pressure with a laser Doppler sensor and a pressure cuff to evaluate reactive hyperemia (Sensilase, Väsamed) and a health survey (SF-12/EQ-5D-5L) or similar. After four weeks and eight weeks of intervention, the same tests will be repeated. A final follow-up test will be two weeks after cessation of the intermittent negative pressure intervention. The study will look at the effect of INP on renal failure patients who are given dialysis at a dialysis center located at Oslo University Hospital, Ullevål. Otivio AS has supplied the FlowOx devices and provided the necessary training to perform this project. Outcome variables assessed before, during and after the 10-week study period will be: wound healing, quality of life, skin perfusion pressure and segmental pulse-volume recording. The aim of this project is to prospectively examine and elucidate the effect of intermittent negative pressure therapy on clinically relevant measures related to the reduction of peripheral macro- and microcirculation in patients with renal failure undergoing dialysis treatment.
The hypothesis of the study is:
- Application of INP in patients with renal failure, by the use of the FlowOx™ device, will improve wound healing and peripheral circulation in the foot compared to before treatment (baseline) in patients undergoing dialysis treatment.
- Application of INP in patients with PAD, by the use of the FlowOx™ device, will improve macro- and microcirculation and wound healing in the foot compared to before treatment (baseline) in patients with chronic wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-case design | Experimental | Device: FlowOx™The study design will be a non-randomized clinical trial with single-subject baseline design (also called single-case baseline design) where each patients act as their own controls: Observations (A) will be taken before and after a 8-week intervention period. We plan to introduce a 4-week INP-treatment period ('FlowOx™) (B) using the same outcome variables that were used as baseline measures. If the patient demonstrates improvements in outcome variables after the first treatment period (B1), the patient will be asked to continue INP therapy for another 4-week period, before a final assessment after a total of 8-week intervention period (B2) (A-B-B design). |
Who may qualify
- Ages
- 18 to 96 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able and willing to provide informed consent
- Age: 18-96 years
- Affected foot/shoe size <46 (approximate foot length< 29,5 cm)
- Receiving hemodialysis ≥3 times per week for 1 hour per treatment OR
- Peripheral arterial disease and leg ulcer
Key exclusion criteria (8 listed)
- Incapable to consent voluntarily, i.e. patients who are not able to consent due to their mental status, or who are not willing or able to perform the negative pressure therapy in a sitting position
- Not adhering to the INP therapy program
- Patients with an expected life-span less than 3 months
- Patients in whom the remaining limb is non-functional, for example due to previous stroke
- Patients in which a deep venous thrombosis or pulmonary embolism is suspected
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 |
|---|---|---|
| FlowOx™Also: Intermittent negative pressure deviceFlowOx™ uses intermittent negative and atmospheric pressure, and is intended for use as an adjunct non-invasive therapy for the treatment of reduced peripheral circulation. Negative pressure cycles are created by alternating between removing air and venting the vacuum-chamber to atmospheric pressure. The vacuum cycle is controlled by the Control Unit (Pump). FlowOx™ is designed to assists wound healing indirectly by improving blood flow to the affected limb and augmenting the wound healing effect of the contact dressings and any associated medication. Treatment is planned to be applied while the participants are seated and it does not interfere with other activities normally enjoyed while seated. Treatment is recommended for one to two hours per session aiming to improve blood flow in the affected area and thus the clinical outcomes. | Device | single-case design |
Primary outcome
Segmental Skin Perfusion Pressure
Time frame: 8 weeks
Fully automated and quantitative evaluation of microcirculatory perfusion in the skin of the foot and leg (Sensilase, Vasamed, USA). Multiple levels can be assessed on limbs; bilateral measurement helps to manage test time Not susceptible to interference effects from medial calcification Requires use of pressure cuffs to occlude blood flow for specified time period in order to evaluate reactive hyperemic response to controlled release of pressure Graphical output of pressure and perfusion during cuff deflation indicates the pressure (mmHg) at which skin perfusion is found to return in addition to pressure contour
Life Quality (SF-12 or EQ-5D-5L)
Time frame: 8 weeks
SF-12 or EQ-5D-5L
Pulse Volume Recording / segmental volume plethysmography (PVR)
Time frame: 8 weeks
PVR shows variations in the volume of blood passing through a limb during each cardiac cycle. The instrument that will be used to measure PVR for this study is Sensilase (Vasamed, USA) OR MacroLab (STR Teknikk, strteknikk.no, Aalesund, Norway). Multiple levels can be assessed on limbs. The measures are not susceptible to interference effects from medial calcification.
Wound healing (Measuring wound diameter and length)
Time frame: 8 weeks
Measurement of healing to provide a means by which progress over time to wound closure can be identified. A wound nurse will take pictures at study start and at follow-up.
Ankle-Brachial Pressure Index (ABPI)
Time frame: 8 weeks
The ratio of the blood pressure at the ankle (dorsal pedis artery/posterior tibial artery) to the blood pressure in the upper arm (brachial artery)
Results and safety
The study was stopped early (reason given: Terminated due to lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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
Oslo University Hospital
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 Renal Disease and Peripheral Arterial Disease, run by Oslo University Hospital 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 5 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: stopped early, as of the sponsor's last update on 6 Apr 2017. 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?
The study was stopped early (reason given: Terminated due to lack of recruitment). 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?
Segmental Skin Perfusion Pressure (time frame: 8 weeks). The study lists 5 primary outcomes in all. 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 6 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.