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Pilot Study on Auricular Vagus Nerve Stimulation Effects in Chronic Diabetic Wounds

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ClinicalTrials.gov Identifier: NCT02098447
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
Vienna University of Technology
Information provided by (Responsible Party):
Dr. Jozsef Constantin Széles, Medical University of Vienna

Study Description
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Brief 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 depends on the health status of the study participants (diseased/healthy).

Condition or disease Intervention/treatment Phase
Chronic Diabetic Foot Ulcers Device: PrimeStim Not Applicable

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. Changes in blood pressure [ Time Frame: within 4 days of intervention ]
    Blood pressure is continuously measured using inflatable finger cuffs.

  4. Changes in respiratory activity [ Time Frame: within 4 days of intervention ]
    Respiratory activity is monitored using a respiratory belt.

  5. Changes in oxygen saturation of the toe and wound [ Time Frame: within 4 days of intervention ]
  6. Changes in partial transcutaneous oxygen pressure of the wound region [ Time Frame: within 4 days of intervention ]
  7. Changes in foot skin temperature [ Time Frame: within 4 days of intervention ]
  8. Changes of C reactive protein- and leukocyte-concentration in serum [ Time Frame: within 4 days of intervention ]
  9. Tolerance of stimulation [ Time Frame: within 4 days of intervention ]
    Tolerance of stimulation is assessed by survey.

  10. Perception of Stimulation [ Time Frame: within 4 days of intervention ]
    Perception of stimulation is assessed by survey.

  11. Adverse effects of stimulation [ Time Frame: within 4 days of intervention ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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


Locations
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Austria
University Clinic for Surgery, Department of Transplantation, Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Vienna University of Technology
Investigators
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Principal Investigator: Jozsef C Széles, Dr.med. University Clinic for Surgery, Department of Transplantation, Medical University Vienna
More Information
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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
Keywords provided by Dr. Jozsef Constantin Széles, Medical University of Vienna:
vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion
Additional relevant MeSH terms:
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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