Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04962048 |
| Other study ID # |
PSyNeP |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 28, 2021 |
| Est. completion date |
May 17, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Orputec |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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).
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).
