Wound Healing, Leg and Foot Ulcers, Macrocirculation, MicrocirculationNCT02866708
The Effects of Intermittent Negative Pressure on Wound Healing and Peripheral Circulation in Spinal Cord Injured Subjects
A study testing Intermittent negative pressure device in people with Wound Healing, Leg and Foot Ulcers, Macrocirculation, Microcirculation, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This is a pilot study to evaluate the treatment effect of INP on wound healing and tissue perfusion for a larger randomized controlled trial (RCT). This randomized cross-over pilot study will look at the effects of intermittent negative pressure (INP) therapy wound healing and the peripheral macro- and… Read more about this study
- Who is it for?
- Ages 18 to 96 years
- Conditions the study is for
- Wound Healing, Leg and Foot Ulcers, Macrocirculation, Microcirculation
- What is being tested?
- Intermittent negative pressure device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jul 2016to 20 Apr 2017
- 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)
- Spinal cord injury preferably with a non-healing leg/foot ulcer/pressure wound for more than 6 weeks
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 which a deep venous thrombosis or pulmonary embolism is suspected
- Bilateral amputation of lower extremity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute and Long-term Clinical Effects of Intermittent Negative Pressure on Wound Healing in Spinal Cord and the Peripheral Circulation in Spinal Cord Injured Subjects
This is a pilot study to evaluate the treatment effect of INP on wound healing and tissue perfusion for a larger randomized controlled trial (RCT). This randomized cross-over pilot study will look at the effects of intermittent negative pressure (INP) therapy wound healing and the peripheral macro- and microcirculation in spinal cord injured patients with chronic leg and foot ulcers (6 weeks or more at inclusion). The project is designed as a randomized clinical trial with single-subject multiple baseline design. We will perform convenience sampling of spinal cord injured patients with leg and foot ulcers, with the last recruitment by the end of december 2016.To ensure equal distribution of participants in each study arm, we will perform block randomization. A statistician will randomized patients to either intervention arm or control arm before start of the study: At baseline, each participants will be randomized into either A) 8 weeks without intervention OR B) 8 weeks with start INP therapy 2 hours per day divided into 2-3 timed sections. After the 8 weeks, participants in the the control group (A) will be re-examined, and start 8-week INP therapy. Also the intervention (INP) will be subjected to the same lower limb in each individual throughout the study period. The other leg will act as a intra-individual control.
At baseline (week 0), and during the course of the study (every 4th week), the participants' wounds will be measured by a wound nurse. Baseline (before start of INP therapy) and after intervention the following measures will be performed: Demographic data (weight, height, ABI), Segmental pulse-volume-recording, Segmental skin perfusion pressure with a laser Doppler sensor and a pressure cuff to evaluate reactive hyperemia (Sensilase, Väsamed) and health surveys (SF-36/EQ-5D-5L and customized wound questionnaire) or similar will be examined at baseline and and the end of the study period. Otivio AS has supplied the FlowOx devices and provided the necessary training to perform this project. Outcome variables assessed before and after the study period will be: wound healing (primary endpoint), quality of life (secondary endpoint), skin perfusion pressure (secondary endpoint), ankle-brachial pressure (secondary endpoint) and segmental pulse-volume recording (secondary endpoint). The aim of this project is to prospectively examine and elucidate the effect of intermittent negative pressure therapy applied to a limited part of the lower limb on clinically relevant measures related to wound healing and peripheral macro- and microcirculation in patients with spinal cord injury.
Read more
The hypotheses of the study are:
- Application of INP in patients with spinal cord injury, by the use of the FlowOx™ device, will improve wound healing in the foot compared to before treatment (baseline) and compared to standard wound care alone.
- Application of INP in patients with spinal cord injury, by the use of the FlowOx™ device, will improve macro- and microcirculation in the foot compared to before treatment (baseline) and compared to standard wound care alone in patients with spinal cord injury.
- Application of INP in patients with spinal cord injury, by the use of the FlowOx™ device, will improve macro- and microcirculation in the intervention foot compared to the control foot and compared to standard wound care alone in patients with spinal cord injury.
- Being tested
- Intermittent negative pressure device
- Medical subject headings
- Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent negative pressure deviceDevice
Also called FlowOx™ , Pulsating negative pressure device, Oscillating negative pressure device
This intervention study will be designed as a randomized cross-over study.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent negative pressure (INP) therapy | Experimental | At baseline, the participants will be randomized into 2 groups: 1) INP therapy or 2) control with no INP therapy.
The 1) patients randomized to INP therapy will start with 8 weeks INP therapy two hours per day divided into timed sections (1-3 times per day or use the device as many times as practical for the individual as long as the total time is two hours). After 8 weeks of INP therapy, final measures will be performed at the Vascular lab before the participants starts their 8-week control period. Receives: Device: Intermittent negative pressure device |
| Control | No intervention | The participants randomized to control will continue their usual wound care for 8 weeks without INP therapy. The control group will start INP therapy after 8 weeks. After 8-weeks without intervention, the participants allocated to the control-group will be asked to start with INP therapy for 8 weeks before a final examination. The participants in the control group will receive vascular assesment at baseline, week 8 (end of control). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in wound healing after 8 weeks of control and after 8 weeks of INP therapy
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. Photographs will be measured and analysed using the ImageJ software. Reference: Schneider, C. A.; Rasband, W. S. \& Eliceiri, K. W. (2012), "NIH Image to ImageJ: 25 years of image analysis", Nature methods 9(7): 671-675, PMID 22930834
Measured: 16 weeks (baseline and after 8 and 16 weeks
Photographic wound assessment tool, PWAT 0-24 score
PWAT is wound assessing tool consisting of 6 domains that assess the composition of the wound bed and viability of the wound edge and periulcer skin that are capable of being viewed using a wound photograph. hese six domains include wound edges, necrotic tissue type and amount, skin color surrounding wound, granulation tissue type, and epithelialization. Scores assigned on a scale of 0 to 4 to each of the domains of the PWAT are summed to derive a total PWAT score between 0 and 24, with zero representing a completely healed ulcer. Reference: Houghton PE, Kincaid CB, Campbell KE, et al. Photographic assessment of the appearance of chronic pressure and leg ulcers. Ostomy/Wound Management. 2000;46(4):20-30
Measured: 16 weeks (baseline and after 8 and 16 weeks
Secondary outcomes (5)
Change in Quality of life (SF-36 ) after 8 weeks of control and after 8 weeks of INP therapy
Measured: 16 weeks (8 weeks intervention+8 weeks control)
Change in Segmental Skin Perfusion Pressure (SPP) after 8 weeks of control and after 8 weeks of INP therapy
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: 16 weeks (8 weeks intervention+8 weeks control)
Change in Pulse Volume Recording (PVR) after 8 weeks of control and after 8 weeks of INP therapy
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: 16 weeks (8 weeks intervention+8 weeks control)
Change in Ankle-Brachial Pressure Index (ABPI) after 8 weeks of control and after 8 weeks of INP therapy
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: 16 weeks (8 weeks intervention+8 weeks control)
Change in Quality of life (EQ-5D-5L) ) after 8 weeks of control and after 8 weeks of INP therapy
Measured: 16 weeks (8 weeks intervention+8 weeks control)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study start1 Jul 2016
- Primary completionApr 2017
- Study completion20 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Healing, Leg and Foot Ulcers, Macrocirculation, MicrocirculationStudies 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
- Crossover
- Model description
- 16 week crossover pilot study comparing intermittent negative pressure (40mmHg) applied to the lower leg and foot plus standard best practice wound care comapred to standard best practice wound care alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 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, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866708
- Sponsor's protocol ID
- 2015/1318 REK sørøst D
- Status last verified
- Sep 2017
- First submitted
- 4 Aug 2016
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Long-term Clinical Effects of Intermittent Negative Pressure on Wound Healing in Spinal Cord and the Peripheral Circulation in Spinal Cord Injured Subjects
- ClinicalTrials.gov ID
- NCT02866708
- Acronym / sponsor ID
- 2015/1318 REK sørøst D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Otivio AS
- Study start
- 1 Jul 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- 20 Apr 2017 (actual)
- First posted
- 15 Aug 2016 (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 is a pilot study to evaluate the treatment effect of INP on wound healing and tissue perfusion for a larger randomized controlled trial (RCT). This randomized cross-over pilot study will look at the effects of intermittent negative pressure (INP) therapy wound healing and the peripheral macro- and microcirculation in spinal cord injured patients with chronic leg and foot ulcers (6 weeks or more at inclusion). The project is designed as a randomized clinical trial with single-subject multiple baseline design. We will perform convenience sampling of spinal cord injured patients with leg and foot ulcers, with the last recruitment by the end of december 2016.To ensure equal distribution of participants in each study arm, we will perform block randomization. A statistician will randomized patients to either intervention arm or control arm before start of the study: At baseline, each participants will be randomized into either A) 8 weeks without intervention OR B) 8 weeks with start INP therapy 2 hours per day divided into 2-3 timed sections. After the 8 weeks, participants in the the control group (A) will be re-examined, and start 8-week INP therapy. Also the intervention (INP) will be subjected to the same lower limb in each individual throughout the study period. The other leg will act as a intra-individual control.
At baseline (week 0), and during the course of the study (every 4th week), the participants' wounds will be measured by a wound nurse. Baseline (before start of INP therapy) and after intervention the following measures will be performed: Demographic data (weight, height, ABI), Segmental pulse-volume-recording, Segmental skin perfusion pressure with a laser Doppler sensor and a pressure cuff to evaluate reactive hyperemia (Sensilase, Väsamed) and health surveys (SF-36/EQ-5D-5L and customized wound questionnaire) or similar will be examined at baseline and and the end of the study period. Otivio AS has supplied the FlowOx devices and provided the necessary training to perform this project. Outcome variables assessed before and after the study period will be: wound healing (primary endpoint), quality of life (secondary endpoint), skin perfusion pressure (secondary endpoint), ankle-brachial pressure (secondary endpoint) and segmental pulse-volume recording (secondary endpoint). The aim of this project is to prospectively examine and elucidate the effect of intermittent negative pressure therapy applied to a limited part of the lower limb on clinically relevant measures related to wound healing and peripheral macro- and microcirculation in patients with spinal cord injury.
The hypotheses of the study are:
- Application of INP in patients with spinal cord injury, by the use of the FlowOx™ device, will improve wound healing in the foot compared to before treatment (baseline) and compared to standard wound care alone.
- Application of INP in patients with spinal cord injury, by the use of the FlowOx™ device, will improve macro- and microcirculation in the foot compared to before treatment (baseline) and compared to standard wound care alone in patients with spinal cord injury.
- Application of INP in patients with spinal cord injury, by the use of the FlowOx™ device, will improve macro- and microcirculation in the intervention foot compared to the control foot and compared to standard wound care alone in patients with spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 16 week crossover pilot study comparing intermittent negative pressure (40mmHg) applied to the lower leg and foot plus standard best practice wound care comapred to standard best practice wound care alone.
| Arm | Type | Receives |
|---|---|---|
| Intermittent negative pressure (INP) therapy | Experimental | Device: Intermittent negative pressure deviceAt baseline, the participants will be randomized into 2 groups: 1) INP therapy or 2) control with no INP therapy. The 1) patients randomized to INP therapy will start with 8 weeks INP therapy two hours per day divided into timed sections (1-3 times per day or use the device as many times as practical for the individual as long as the total time is two hours). After 8 weeks of INP therapy, final measures will be performed at the Vascular lab before the participants starts their 8-week control period. |
| Control | No intervention | –The participants randomized to control will continue their usual wound care for 8 weeks without INP therapy. The control group will start INP therapy after 8 weeks. After 8-weeks without intervention, the participants allocated to the control-group will be asked to start with INP therapy for 8 weeks before a final examination. The participants in the control group will receive vascular assesment at baseline, week 8 (end of control). |
Who may qualify
- Ages
- 18 to 96 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able and willing to provide informed consent
- Age: 18-96 years
- Affected foot/shoe size <46 (approximate foot length< 29,5 cm)
- Spinal cord injury preferably with a non-healing leg/foot ulcer/pressure wound for more than 6 weeks
Key exclusion criteria (5 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 which a deep venous thrombosis or pulmonary embolism is suspected
- Bilateral amputation of lower extremity
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 |
|---|---|---|
| Intermittent negative pressure deviceAlso: FlowOx™ , Pulsating negative pressure device, Oscillating negative pressure deviceThis intervention study will be designed as a randomized cross-over study. | Device | Intermittent negative pressure (INP) therapy |
Primary outcome
Percentage change in wound healing after 8 weeks of control and after 8 weeks of INP therapy
Time frame: 16 weeks (baseline and after 8 and 16 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. Photographs will be measured and analysed using the ImageJ software. Reference: Schneider, C. A.; Rasband, W. S. \& Eliceiri, K. W. (2012), "NIH Image to ImageJ: 25 years of image analysis", Nature methods 9(7): 671-675, PMID 22930834
Photographic wound assessment tool, PWAT 0-24 score
Time frame: 16 weeks (baseline and after 8 and 16 weeks
PWAT is wound assessing tool consisting of 6 domains that assess the composition of the wound bed and viability of the wound edge and periulcer skin that are capable of being viewed using a wound photograph. hese six domains include wound edges, necrotic tissue type and amount, skin color surrounding wound, granulation tissue type, and epithelialization. Scores assigned on a scale of 0 to 4 to each of the domains of the PWAT are summed to derive a total PWAT score between 0 and 24, with zero representing a completely healed ulcer. Reference: Houghton PE, Kincaid CB, Campbell KE, et al. Photographic assessment of the appearance of chronic pressure and leg ulcers. Ostomy/Wound Management. 2000;46(4):20-30
5 secondary outcomes
Change in Quality of life (SF-36 ) after 8 weeks of control and after 8 weeks of INP therapy
Time frame: 16 weeks (8 weeks intervention+8 weeks control)
Change in Segmental Skin Perfusion Pressure (SPP) after 8 weeks of control and after 8 weeks of INP therapy
Time frame: 16 weeks (8 weeks intervention+8 weeks control)
Change in Pulse Volume Recording (PVR) after 8 weeks of control and after 8 weeks of INP therapy
Time frame: 16 weeks (8 weeks intervention+8 weeks control)
Change in Ankle-Brachial Pressure Index (ABPI) after 8 weeks of control and after 8 weeks of INP therapy
Time frame: 16 weeks (8 weeks intervention+8 weeks control)
Change in Quality of life (EQ-5D-5L) ) after 8 weeks of control and after 8 weeks of INP therapy
Time frame: 16 weeks (8 weeks intervention+8 weeks control)
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 7 Sep 2017.
- Individual participant dataSharing planned: Yes
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 Intermittent negative pressure device in people with Wound Healing, Leg and Foot Ulcers, Macrocirculation, Microcirculation, 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 4 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 7 Sep 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 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?
Percentage change in wound healing after 8 weeks of control and after 8 weeks of INP therapy (time frame: 16 weeks (baseline and after 8 and 16 weeks). 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?
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 7 Sep 2017.