Pilot Study on Auricular Vagus Nerve Stimulation Effects in Chronic Diabetic Wounds
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02098447 |
Recruitment Status :
Completed
First Posted : March 28, 2014
Last Update Posted : March 31, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Diabetic Foot Ulcers | Device: PrimeStim | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Evaluation of Electrical Auricular Vagal Nerve Stimulation Effects on Parameters of Wound Healing in Chronic Diabetic Wounds - Pilot Study |
Study Start Date : | February 2014 |
Actual Primary Completion Date : | April 13, 2015 |
Actual Study Completion Date : | April 13, 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: auricular vagal nerve stimulation
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. |
Device: PrimeStim |
- 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.
- Change in HRV and local BPI due to distinct stimulation patterns [ Time Frame: within 4 days of intervention ]
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.
- Change of local BPI in upper and lower extremities [ Time Frame: within 4 days of intervention ]
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.
- Changes in blood pressure [ Time Frame: within 4 days of intervention ]Blood pressure is continuously measured using inflatable finger cuffs.
- Changes in respiratory activity [ Time Frame: within 4 days of intervention ]Respiratory activity is monitored using a respiratory belt.
- 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 ]Tolerance of stimulation is assessed by survey.
- Perception of Stimulation [ Time Frame: within 4 days of intervention ]Perception of stimulation is assessed by survey.
- Adverse effects of stimulation [ Time Frame: within 4 days of intervention ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- diabetes mellitus type 2
- ulcus cruris (plantar)
- min. 6 weeks of standard wound therapy without success
- intact big toe on wound side
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098447
Austria | |
University Clinic for Surgery, Department of Transplantation, Medical University Vienna | |
Vienna, Austria, 1090 |
Principal Investigator: | Jozsef C Széles, Dr.med. | University Clinic for Surgery, Department of Transplantation, Medical University Vienna |
Responsible Party: | Dr. Jozsef Constantin Széles, Dr.med., Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT02098447 |
Other Study ID Numbers: |
PS 01/2014 |
First Posted: | March 28, 2014 Key Record Dates |
Last Update Posted: | March 31, 2017 |
Last Verified: | March 2017 |
vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion |
Diabetic Foot Foot Ulcer Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Leg Ulcer Skin Ulcer |
Skin Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies Foot Diseases |