MicrocirculationPSyNePNCT04962048
The Influence of Pulse-synchronized Negative Pressure on the Dermal Microcirculation
A study testing pulse-synchronized negative pressure (PSNP) device in people with Microcirculation and Diabetes, run by Orputec at 1 site in Austria.
Trial summary
The technology of the pulse-synchronous alternating pressure system has been patented and is ready for application. Since the device is a combination of commercially available products with a software controlling the duration/initiation of the negative pressure, no harm for the study participant is expected. Read more about this study
- Who is it for?
- Ages 45 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Microcirculation, Diabetes
- What is being tested?
- pulse-synchronized negative pressure (PSNP) device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteAustria
- Study dates
- 28 May 2021to 17 May 2022
- 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 45 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female individuals suffering from DM type 2 and willing to participate in this study
- First diagnosis of DM type 2 at least 10 years prior to inclusion OR presence of diabetic dermopathy.
- Age: 45-99
- Written consent of the participant after being informed
Who cannot join
- Skin lesions or dermatoses in the region of interest (ROI)
- Non-ability to comprehend the nature and course of the study
Trial locations and contacts
1 site in 1 country.
Austria1 site
Division of Plastic, Aesthetic and Reconstructive Surgery
Graz, Styira, 8036
About this study
The technology of the pulse-synchronous alternating pressure system has been patented and is ready for application. Since the device is a combination of commercially available products with a software controlling the duration/initiation of the negative pressure, no harm for the study participant is expected. With no adequate preclinical model of impaired microcirculation being available, and due to the non-invasive nature of the device, the rationale to test the product in a controlled setting in clinical patients is justified. The intervention takes place twice a day for two consecutive days with objective assessment of the microcirculation before and after the intervention. Thereby, the immediate effect of the intervention is to be evaluated. A fifth assessment takes place on the third day without prior intervention to assess a possible long-term effect (comparison against first measurement - base line).
The primary aim of this project is to investigate the tolerability and the comfort of pulse-synchronized negative pressure (PSNP) applied by the device manufactured by Orputec GmbH on the dermal microcirculation. Evaluation of patient comfort and tolerability will be performed by a Numerical Rating Scale (NRS).
Read more
The application of the device (PSNP) significantly influences the dermal microcirculation (measuring by LD, HS, TH).
The aims of this project is to investigate the tolerability / comfort and the effect of pulse-synchronized negative pressure (PSNP) applied by the device manufactured by Orputec GmbH on the dermal microcirculation. Objective evaluation of microcirculation with laser doppler (LD), hyperspectral imaging (HS), thermal imaging (TH).
Read the detailed description
Orputec has developed a device that uses the technology of a pulse-synchronized alternating pressure system. It can be applied in the field of regenerative medicine to treat lymphedema by improving the blood- and lymphatic circulation. The machine consists of four components: an electrocardiograph (ECG), a vacuum pump, a software controlling the timing of suction and drainage, and an individual suction cap for each patient.
The study is designed as an open, interventional cohort, intraindividually controlled, pilot study. A pilot sample size of 12 is chosen because the device will be tested in a controlled setting for the first time. No formal sample size calculation was performed.
The collective consists of 12 subjects, with diabetes mellitus (DM) type 2 but no apparent wounds on the lower leg. Before inclusion, subjects will be screened for current skin lesions in the region of interest (ROI), comorbidities, and their medical history concerning diabetes and skin lesions. The ROI on both lower legs will be marked, and the dermal microcirculation will be measured, non-invasively, using LD, HS, and TH. After ensuring a comfortable position, each subject will receive treatment with the PSNP device on one chosen lower leg for 120 minutes. During the treatment, a warming unit, which is also used after flap surgery to maintain an adequate ambient temperature, will be used to obtain local thermal hyperaemia, hence a prospected dilation of the vessels. The non-invasive imaging (LD, HS, TH) will be performed before and after the intervention. This treatment course will be applied twice a day (with 4h +/- 2h in between) for two consecutive days. Toleration of the treatment and wellbeing of the subjects will be assessed by a Visual Analog Scale (VAS). Finally, another series of imaging (LD, HS, TH) will be performed on the morning of the third day without a prior intervention.
Statistical analysis of numeric endpoints: All numeric endpoints will be checked for normality, e.g. by using a Shapiro-Wilk test. If a numeric endpoint deviates from normality, then data transformations (e.g. log-transformation) will be considered. Numeric endpoints will be analysed by means of a repeated measures analysis of variance (ANOVA). The level of significance will be set to 5% in all analyses. No adjustment for multiple comparisons will be performed.
Additionally, the following comparisons will be performed by using descriptive statistics (e.g. Q1, median, Q3, mean, standard deviation) and graphical methods (e.g. box plots):
- Comparison of time points (prior to intervention on day 1; after intervention on day 1; prior to control on day 1; after control on day 1 and day 3) within each treatment condition (intervention: treated leg; control: untreated leg).
- Comparison of treatment conditions (treated vs. untreated legs) for each time point.
In order to identify influencing factors for the effect of the PSNP treatment, the investigators will use graphical methods as well as regression models and mixed effects models (e.g., analysis of covariance).
- Conditions
- Microcirculation, Diabetes
- Being tested
- pulse-synchronized negative pressure (PSNP) device, Control - no intervention
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulse-synchronized negative pressure (PSNP) deviceDevice
The machine consists of four components: an electrocardiograph (ECG), a vacuum pump, a software computing the timing of suction and drainage, and an individual suction cap for each patient. One leg will be treated with the PSNP-device. The treatment course with PSNP will be applied twice a day (with 4h +/- 2h in between) for two consecutive days.
Control - no interventionOther
The other leg serves as non-treated control
| Study group | Role | What they receive |
|---|---|---|
| pulse-synchronized negative pressure (PSNP) device | Experimental | One leg will be treated with the pulse-synchronized negative pressure (PSNP). The other leg serves as non-treated control. Receives: Device: pulse-synchronized negative pressure (PSNP) device; Other: Control - no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of toleration / wellbeeing due to intervention of PSNP with Numeric Rating Scale
Successful intervention with the PSNP device without harm to the patients. Change of toleration of the treatment and wellbeing of the subjects will be assessed by a Numerical Rating Scale (scale 0 - 10)
Measured: 2 times on day 1 and day 2
Secondary outcomes (3)
Change of microcirculation with laser doppler (LD)
LD is measuring the blood flow: Blood flow is then calculated in a unit called Flux based on the red cell concentration in red cell velocity. The blood flow correlates directly to the microcirculation in the skin. A higher blood flow indicates a better microcirculation.
Measured: 4 times on day 1 and 2; once on day 3
Change of microcirculation with hyperspectral imaging (HS)
HS is measuring oxygenation in the blood: The oxygenation index is given in percent. The oxygenation correlates directly to the microcirculation in the skin. A higher blood oxygenation indicates a better microcirculation.
Measured: 4 times on day 1 and 2; once on day 3
Change of microcirculation with thermal imaging (TH)
Objective evaluation of microcirculation with thermal imaging (TH). TH is measuring the skin temperature in Kelvin. The skin temperature correlates directly to the blood flow and the microcirculation in the skin. A higher skin temperature indicates a better microcirculation.
Measured: 4 times on day 1 and 2; once on day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start28 May 2021
- Primary completion17 May 2022
- Study completion17 May 2022
Why it stopped: Results not goal-oriented, premature termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrocirculationStudies 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- After ensuring a comfortable position, each subject will receive treatment with the pulse-synchronized negative pressure (PSNP) device on one randomly chosen lower leg for 120 minutes.The non-invasive imaging (Laser-Doppler Imaging = LD , Hyperspectral Imaging = HS, Thermal Imaging = TH) will be performed before and after the intervention. This treatment course will be applied twice a day (with 4h +/- 2h in between) for two consecutive days. Toleration of the treatment and wellbeing of the subjects will be assessed by a Visual Analogue Scale. Finally, another series of imaging (LD, HS, TH) will be performed on the morning of the third day without a prior intervention.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orputec
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Graz, Joanneum Research Forschungsgesellschaft mbH
- Responsible party
- Sponsor
- Investigators
- Lars-Peter Kamolz, Univ.-Prof., Principal investigator, Medical University of Graz, Graz, Styria, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962048
- Sponsor's protocol ID
- PSyNeP
- Acronym
- PSyNeP
- Status last verified
- Jul 2022
- First submitted
- 17 Jun 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Pulse-synchronized Negative Pressure on the Dermal Microcirculation
- ClinicalTrials.gov ID
- NCT04962048
- Acronym / sponsor ID
- PSyNeP / PSyNeP
- Conditions
- Microcirculation, Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results not goal-oriented, premature termination.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- OrputecUniversity, hospital or other
- Collaborators
- Medical University of Graz, Joanneum Research Forschungsgesellschaft mbH
- Study start
- 28 May 2021 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 14 Jul 2021 (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.
The technology of the pulse-synchronous alternating pressure system has been patented and is ready for application. Since the device is a combination of commercially available products with a software controlling the duration/initiation of the negative pressure, no harm for the study participant is expected. With no adequate preclinical model of impaired microcirculation being available, and due to the non-invasive nature of the device, the rationale to test the product in a controlled setting in clinical patients is justified. The intervention takes place twice a day for two consecutive days with objective assessment of the microcirculation before and after the intervention. Thereby, the immediate effect of the intervention is to be evaluated. A fifth assessment takes place on the third day without prior intervention to assess a possible long-term effect (comparison against first measurement - base line).
The primary aim of this project is to investigate the tolerability and the comfort of pulse-synchronized negative pressure (PSNP) applied by the device manufactured by Orputec GmbH on the dermal microcirculation. Evaluation of patient comfort and tolerability will be performed by a Numerical Rating Scale (NRS).
The application of the device (PSNP) significantly influences the dermal microcirculation (measuring by LD, HS, TH).
The aims of this project is to investigate the tolerability / comfort and the effect of pulse-synchronized negative pressure (PSNP) applied by the device manufactured by Orputec GmbH on the dermal microcirculation. Objective evaluation of microcirculation with laser doppler (LD), hyperspectral imaging (HS), thermal imaging (TH).
Detailed description
Orputec has developed a device that uses the technology of a pulse-synchronized alternating pressure system. It can be applied in the field of regenerative medicine to treat lymphedema by improving the blood- and lymphatic circulation. The machine consists of four components: an electrocardiograph (ECG), a vacuum pump, a software controlling the timing of suction and drainage, and an individual suction cap for each patient.
The study is designed as an open, interventional cohort, intraindividually controlled, pilot study. A pilot sample size of 12 is chosen because the device will be tested in a controlled setting for the first time. No formal sample size calculation was performed.
The collective consists of 12 subjects, with diabetes mellitus (DM) type 2 but no apparent wounds on the lower leg. Before inclusion, subjects will be screened for current skin lesions in the region of interest (ROI), comorbidities, and their medical history concerning diabetes and skin lesions. The ROI on both lower legs will be marked, and the dermal microcirculation will be measured, non-invasively, using LD, HS, and TH. After ensuring a comfortable position, each subject will receive treatment with the PSNP device on one chosen lower leg for 120 minutes. During the treatment, a warming unit, which is also used after flap surgery to maintain an adequate ambient temperature, will be used to obtain local thermal hyperaemia, hence a prospected dilation of the vessels. The non-invasive imaging (LD, HS, TH) will be performed before and after the intervention. This treatment course will be applied twice a day (with 4h +/- 2h in between) for two consecutive days. Toleration of the treatment and wellbeing of the subjects will be assessed by a Visual Analog Scale (VAS). Finally, another series of imaging (LD, HS, TH) will be performed on the morning of the third day without a prior intervention.
Statistical analysis of numeric endpoints: All numeric endpoints will be checked for normality, e.g. by using a Shapiro-Wilk test. If a numeric endpoint deviates from normality, then data transformations (e.g. log-transformation) will be considered. Numeric endpoints will be analysed by means of a repeated measures analysis of variance (ANOVA). The level of significance will be set to 5% in all analyses. No adjustment for multiple comparisons will be performed.
Additionally, the following comparisons will be performed by using descriptive statistics (e.g. Q1, median, Q3, mean, standard deviation) and graphical methods (e.g. box plots):
- Comparison of time points (prior to intervention on day 1; after intervention on day 1; prior to control on day 1; after control on day 1 and day 3) within each treatment condition (intervention: treated leg; control: untreated leg).
- Comparison of treatment conditions (treated vs. untreated legs) for each time point.
In order to identify influencing factors for the effect of the PSNP treatment, the investigators will use graphical methods as well as regression models and mixed effects models (e.g., analysis of covariance).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- After ensuring a comfortable position, each subject will receive treatment with the pulse-synchronized negative pressure (PSNP) device on one randomly chosen lower leg for 120 minutes.The non-invasive imaging (Laser-Doppler Imaging = LD , Hyperspectral Imaging = HS, Thermal Imaging = TH) will be performed before and after the intervention. This treatment course will be applied twice a day (with 4h +/- 2h in between) for two consecutive days. Toleration of the treatment and wellbeing of the subjects will be assessed by a Visual Analogue Scale. Finally, another series of imaging (LD, HS, TH) will be performed on the morning of the third day without a prior intervention.
| Arm | Type | Receives |
|---|---|---|
| pulse-synchronized negative pressure (PSNP) device | Experimental | Device: pulse-synchronized negative pressure (PSNP) device, Other: Control - no interventionOne leg will be treated with the pulse-synchronized negative pressure (PSNP). The other leg serves as non-treated control. |
Who may qualify
- Ages
- 45 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female individuals suffering from DM type 2 and willing to participate in this study
- First diagnosis of DM type 2 at least 10 years prior to inclusion OR presence of diabetic dermopathy.
- Age: 45-99
- Written consent of the participant after being informed
Key exclusion criteria (2 listed)
- Skin lesions or dermatoses in the region of interest (ROI)
- Non-ability to comprehend the nature and course of the study
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 |
|---|---|---|
| pulse-synchronized negative pressure (PSNP) deviceThe machine consists of four components: an electrocardiograph (ECG), a vacuum pump, a software computing the timing of suction and drainage, and an individual suction cap for each patient. One leg will be treated with the PSNP-device. The treatment course with PSNP will be applied twice a day (with 4h +/- 2h in between) for two consecutive days. | Device | pulse-synchronized negative pressure (PSNP) device |
| Control - no interventionThe other leg serves as non-treated control | Other | pulse-synchronized negative pressure (PSNP) device |
Primary outcome
Change of toleration / wellbeeing due to intervention of PSNP with Numeric Rating Scale
Time frame: 2 times on day 1 and day 2
Successful intervention with the PSNP device without harm to the patients. Change of toleration of the treatment and wellbeing of the subjects will be assessed by a Numerical Rating Scale (scale 0 - 10)
3 secondary outcomes
Change of microcirculation with laser doppler (LD)
Time frame: 4 times on day 1 and 2; once on day 3
Change of microcirculation with hyperspectral imaging (HS)
Time frame: 4 times on day 1 and 2; once on day 3
Change of microcirculation with thermal imaging (TH)
Time frame: 4 times on day 1 and 2; once on day 3
Results and safety
The study was stopped early (reason given: Results not goal-oriented, premature termination.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
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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.
Lars-Peter Kamolz, Univ.-Prof. principal investigator
Medical University of Graz, Graz, Styria, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulse-synchronized negative pressure (PSNP) device in people with Microcirculation and Diabetes, run by Orputec at 1 site in Austria.
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 2 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 11 Jul 2022. 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 Austria. 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: Results not goal-oriented, premature termination.). 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?
Change of toleration / wellbeeing due to intervention of PSNP with Numeric Rating Scale (time frame: 2 times on day 1 and day 2). 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 11 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.