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

Not Applicable

Completed

• Conditions: Chronic Diabetic Foot Ulcers
• Interventions: Device: PrimeStim

• Registration Number: NCT02098447
• Lead Sponsor: Medical University of Vienna

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-03-28
• Primary Completion: 2015-04-13
• Study Completion: 2015-04-13
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• diabetes mellitus type 2
• ulcus cruris (plantar)
• min. 6 weeks of standard wound therapy without success
• intact big toe on wound side

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
auricular vagal nerve stimulation	PrimeStim	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.

Primary Outcome Measures

Name	Time	Method
change in heart rate variability (HRV) related to physiological state (diabetics/healthy)	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)	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

Name	Time	Method
Perception of Stimulation	within 4 days of intervention	Perception of stimulation is assessed by survey.
Change in HRV and local BPI due to distinct stimulation patterns	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.
Changes in respiratory activity	within 4 days of intervention	Respiratory activity is monitored using a respiratory belt.
Changes in partial transcutaneous oxygen pressure of the wound region	within 4 days of intervention
Changes in oxygen saturation of the toe and wound	within 4 days of intervention
Tolerance of stimulation	within 4 days of intervention	Tolerance of stimulation is assessed by survey.
Changes in blood pressure	within 4 days of intervention	Blood pressure is continuously measured using inflatable finger cuffs.
Change of local BPI in upper and lower extremities	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 foot skin temperature	within 4 days of intervention
Changes of C reactive protein- and leukocyte-concentration in serum	within 4 days of intervention
Adverse effects of stimulation	within 4 days of intervention

Trial Locations

Locations (1)

University Clinic for Surgery, Department of Transplantation, Medical University Vienna; 🇦🇹 Vienna, Austria