Chronic Diabetic Foot UlcersNCT02098447
Pilot Study on Auricular Vagus Nerve Stimulation Effects in Chronic Diabetic Wounds
A study testing PrimeStim in people with Chronic Diabetic Foot Ulcers, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous system stimulation on vital parameters of wound healing in diabetics. It is investigated if auricular vagal nerve stimulation has an effect on heart rate variability as well as peripheral local blood perfusion, and if this effect… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Diabetic Foot Ulcers
- What is being tested?
- PrimeStim
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2014to 13 Apr 2015
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diabetes mellitus type 2
- ulcus cruris (plantar)
- min. 6 weeks of standard wound therapy without success
- intact big toe on wound side
Who cannot join
- participation in a clinical trial in the last 5 weeks
- confounding medical treatment, e.g. prostaglandin
- vascular diseases other than peripheral arterial occlusive disease
- diseases which may affect the autonomous nervous system or wound healing, except diabetic concomitant diseases (e.g., polyneuropathy, angiopathy)
- drug abuse
- active implanted devices
- pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
Austria1 site
University Clinic for Surgery, Department of Transplantation, Medical University Vienna
Vienna, State of Vienna, 1090
About this study
Official title: Evaluation of Electrical Auricular Vagal Nerve Stimulation Effects on Parameters of Wound Healing in Chronic Diabetic Wounds - Pilot Study
The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous system stimulation on vital parameters of wound healing in diabetics. It is investigated if auricular vagal nerve stimulation has an effect on heart rate variability as well as peripheral local blood perfusion, and if this effect depends on the health status of the study participants (diseased/healthy).
- Conditions
- Chronic Diabetic Foot Ulcers
- Being tested
- PrimeStim
- Keywords
- vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrimeStimDevice
| Study group | Role | What they receive |
|---|---|---|
| auricular vagal nerve stimulation | Experimental | Study participants (healthy and diabetics) are treated with auricular vagal nerve stimulation using four needle electrodes connected to an electrical stimulation device (PrimeStim). After an acclimatization phase the stimulation is turned on for 20 minutes followed by 20 minutes of paused stimulation, 20 minutes of stimulation, and another 10 minutes paused stimulation. This intervention is repeated on four consecutive days. Needle electrodes stay fixed over the whole study period.
Two different stimulation schemes are tested, each being assessed twice in random order. Stimulation amplitudes are adjusted with respect to a distinct but comfortable sensation at the auricle.
During the described protocol various biosignals are continuously recorded, including ECG, respiration, blood perfusion, oxygen saturation, transcutaneous oxygen tension, blood pressure and skin temperature. Receives: Device: PrimeStim |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in heart rate variability (HRV) related to physiological state (diabetics/healthy)
Heart rate variability will be assessed as, e.g., standard deviation in heart rate over a time window of 5 minutes (30 seconds overlap).
Changes in mean value and standard deviation of heart rate variability between healthy and diabetic patients will be assessed using statistical tests.
Measured: within 4 days of intervention
change in local blood perfusion index (BPI) related to physiological state (diabetics/healthy)
Blood perfusion index at the foot will be assessed as peak-peak amplitude (systolic to diastolic) divided by the mean signal value of optically measured blood perfusion.
Changes in mean value and standard deviation of local blood perfusion index between healthy and diabetic patients will be assessed using statistical tests.
Measured: within 4 days of intervention
Secondary outcomes (11)
Change in HRV and local BPI due to distinct stimulation patterns
Two distinct stimulation patterns are tested during intervention.
Changes in mean value and standard deviation of HRV/BPI due to these stimulation patterns will be assessed using statistical tests.
Measured: within 4 days of intervention
Change of local BPI in upper and lower extremities
Local BPI is assessed using optical sensors on the foot and the finger of participants.
Changes in mean value of BPI are analyzed using statistical tests.
Measured: within 4 days of intervention
Changes in blood pressure
Blood pressure is continuously measured using inflatable finger cuffs.
Measured: within 4 days of intervention
Changes in respiratory activity
Respiratory activity is monitored using a respiratory belt.
Measured: within 4 days of intervention
Changes in oxygen saturation of the toe and wound
Measured: within 4 days of intervention
Changes in partial transcutaneous oxygen pressure of the wound region
Measured: within 4 days of intervention
Changes in foot skin temperature
Measured: within 4 days of intervention
Changes of C reactive protein- and leukocyte-concentration in serum
Measured: within 4 days of intervention
Tolerance of stimulation
Tolerance of stimulation is assessed by survey.
Measured: within 4 days of intervention
Perception of Stimulation
Perception of stimulation is assessed by survey.
Measured: within 4 days of intervention
Adverse effects of stimulation
Measured: within 4 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completion13 Apr 2015
- Study completion13 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Diabetic Foot UlcersStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Vienna University of Technology
- Responsible party
- Principal investigator, Dr. Jozsef Constantin Széles, Medical University of Vienna
- Investigators
- Jozsef C Széles, Dr.med., Principal investigator, University Clinic for Surgery, Department of Transplantation, Medical University Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098447
- Sponsor's protocol ID
- PS 01/2014
- Status last verified
- Mar 2017
- First submitted
- 20 Mar 2014
- Last updated
- 31 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Electrical Auricular Vagal Nerve Stimulation Effects on Parameters of Wound Healing in Chronic Diabetic Wounds - Pilot Study
- ClinicalTrials.gov ID
- NCT02098447
- Acronym / sponsor ID
- PS 01/2014
- Conditions
- Chronic Diabetic Foot Ulcers
- Keywords
- vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Vienna University of Technology
- Study start
- Feb 2014
- Primary completion
- 13 Apr 2015 (actual)
- Study completion
- 13 Apr 2015 (actual)
- First posted
- 28 Mar 2014 (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.
The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous system stimulation on vital parameters of wound healing in diabetics. It is investigated if auricular vagal nerve stimulation has an effect on heart rate variability as well as peripheral local blood perfusion, and if this effect depends on the health status of the study participants (diseased/healthy).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| auricular vagal nerve stimulation | Experimental | Device: PrimeStimStudy participants (healthy and diabetics) are treated with auricular vagal nerve stimulation using four needle electrodes connected to an electrical stimulation device (PrimeStim). After an acclimatization phase the stimulation is turned on for 20 minutes followed by 20 minutes of paused stimulation, 20 minutes of stimulation, and another 10 minutes paused stimulation. This intervention is repeated on four consecutive days. Needle electrodes stay fixed over the whole study period. Two different stimulation schemes are tested, each being assessed twice in random order. Stimulation amplitudes are adjusted with respect to a distinct but comfortable sensation at the auricle. During the described protocol various biosignals are continuously recorded, including ECG, respiration, blood perfusion, oxygen saturation, transcutaneous oxygen tension, blood pressure and skin temperature. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diabetes mellitus type 2
- ulcus cruris (plantar)
- min. 6 weeks of standard wound therapy without success
- intact big toe on wound side
Key exclusion criteria (7 listed)
- participation in a clinical trial in the last 5 weeks
- confounding medical treatment, e.g. prostaglandin
- vascular diseases other than peripheral arterial occlusive disease
- diseases which may affect the autonomous nervous system or wound healing, except diabetic concomitant diseases (e.g., polyneuropathy, angiopathy)
- drug abuse
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 |
|---|---|---|
| PrimeStim | Device | auricular vagal nerve stimulation |
Primary outcome
change in heart rate variability (HRV) related to physiological state (diabetics/healthy)
Time frame: within 4 days of intervention
Heart rate variability will be assessed as, e.g., standard deviation in heart rate over a time window of 5 minutes (30 seconds overlap). Changes in mean value and standard deviation of heart rate variability between healthy and diabetic patients will be assessed using statistical tests.
change in local blood perfusion index (BPI) related to physiological state (diabetics/healthy)
Time frame: within 4 days of intervention
Blood perfusion index at the foot will be assessed as peak-peak amplitude (systolic to diastolic) divided by the mean signal value of optically measured blood perfusion. Changes in mean value and standard deviation of local blood perfusion index between healthy and diabetic patients will be assessed using statistical tests.
11 secondary outcomes
Change in HRV and local BPI due to distinct stimulation patterns
Time frame: within 4 days of intervention
Change of local BPI in upper and lower extremities
Time frame: within 4 days of intervention
Changes in blood pressure
Time frame: within 4 days of intervention
Changes in respiratory activity
Time frame: within 4 days of intervention
Changes in oxygen saturation of the toe and wound
Time frame: within 4 days of intervention
Changes in partial transcutaneous oxygen pressure of the wound region
Time frame: within 4 days of intervention
Changes in foot skin temperature
Time frame: within 4 days of intervention
Changes of C reactive protein- and leukocyte-concentration in serum
Time frame: within 4 days of intervention
Tolerance of stimulation
Time frame: within 4 days of intervention
Perception of Stimulation
Time frame: within 4 days of intervention
Adverse effects of stimulation
Time frame: within 4 days of intervention
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 31 Mar 2017.
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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.
Jozsef C Széles, Dr.med. principal investigator
University Clinic for Surgery, Department of Transplantation, Medical University Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrimeStim in people with Chronic Diabetic Foot Ulcers, run by Medical University of Vienna 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 7 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 31 Mar 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 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 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 heart rate variability (HRV) related to physiological state (diabetics/healthy) (time frame: within 4 days of intervention). 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 31 Mar 2017; AzTrials last refreshed its copy on 30 Oct 2026.