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

Primary Purpose

Chronic Diabetic Foot Ulcers

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
PrimeStim
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Diabetic Foot Ulcers focused on measuring vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Clinic for Surgery, Department of Transplantation, Medical University Vienna

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

auricular vagal nerve stimulation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
Changes in blood pressure
Blood pressure is continuously measured using inflatable finger cuffs.
Changes in respiratory activity
Respiratory activity is monitored using a respiratory belt.
Changes in oxygen saturation of the toe and wound
Changes in partial transcutaneous oxygen pressure of the wound region
Changes in foot skin temperature
Changes of C reactive protein- and leukocyte-concentration in serum
Tolerance of stimulation
Tolerance of stimulation is assessed by survey.
Perception of Stimulation
Perception of stimulation is assessed by survey.
Adverse effects of stimulation

Full Information

First Posted
March 20, 2014
Last Updated
March 30, 2017
Sponsor
Medical University of Vienna
Collaborators
Vienna University of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02098447
Brief Title
Pilot Study on Auricular Vagus Nerve Stimulation Effects in Chronic Diabetic Wounds
Official Title
Evaluation of Electrical Auricular Vagal Nerve Stimulation Effects on Parameters of Wound Healing in Chronic Diabetic Wounds - Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
April 13, 2015 (Actual)
Study Completion Date
April 13, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
Vienna University of Technology

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diabetic Foot Ulcers
Keywords
vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
auricular vagal nerve stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
PrimeStim
Primary Outcome Measure Information:
Title
change in heart rate variability (HRV) related to physiological state (diabetics/healthy)
Description
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.
Time Frame
within 4 days of intervention
Title
change in local blood perfusion index (BPI) related to physiological state (diabetics/healthy)
Description
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.
Time Frame
within 4 days of intervention
Secondary Outcome Measure Information:
Title
Change in HRV and local BPI due to distinct stimulation patterns
Description
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.
Time Frame
within 4 days of intervention
Title
Change of local BPI in upper and lower extremities
Description
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.
Time Frame
within 4 days of intervention
Title
Changes in blood pressure
Description
Blood pressure is continuously measured using inflatable finger cuffs.
Time Frame
within 4 days of intervention
Title
Changes in respiratory activity
Description
Respiratory activity is monitored using a respiratory belt.
Time Frame
within 4 days of intervention
Title
Changes in oxygen saturation of the toe and wound
Time Frame
within 4 days of intervention
Title
Changes in partial transcutaneous oxygen pressure of the wound region
Time Frame
within 4 days of intervention
Title
Changes in foot skin temperature
Time Frame
within 4 days of intervention
Title
Changes of C reactive protein- and leukocyte-concentration in serum
Time Frame
within 4 days of intervention
Title
Tolerance of stimulation
Description
Tolerance of stimulation is assessed by survey.
Time Frame
within 4 days of intervention
Title
Perception of Stimulation
Description
Perception of stimulation is assessed by survey.
Time Frame
within 4 days of intervention
Title
Adverse effects of stimulation
Time Frame
within 4 days of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jozsef C Széles, Dr.med.
Organizational Affiliation
University Clinic for Surgery, Department of Transplantation, Medical University Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic for Surgery, Department of Transplantation, Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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

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