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

Chronic Diabetic Foot Ulcers Clinical Trial

Official title:

Evaluation of Electrical Auricular Vagal Nerve Stimulation Effects on Parameters of Wound Healing in Chronic Diabetic Wounds - Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098447
• Other study ID #: PS 01/2014
• Status: Completed
• Phase: N/A
• First received: March 20, 2014
• Last updated: March 30, 2017
• Start date: February 2014
• Est. completion date: April 13, 2015

Study information

• Verified date: March 2017
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 depends on the health status of the study participants (diseased/healthy).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 13, 2015
• Est. primary completion date: April 13, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Diabetic Foot Ulcers
• Diabetic Foot
• Foot Ulcer

Intervention

Device:
• PrimeStim

Locations

Country	Name	City	State
Austria	University Clinic for Surgery, Department of Transplantation, Medical University Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Vienna University of Technology

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 4 days of intervention
Primary	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.	within 4 days of intervention
Secondary	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.	within 4 days of intervention
Secondary	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.	within 4 days of intervention
Secondary	Changes in blood pressure	Blood pressure is continuously measured using inflatable finger cuffs.	within 4 days of intervention
Secondary	Changes in respiratory activity	Respiratory activity is monitored using a respiratory belt.	within 4 days of intervention
Secondary	Changes in oxygen saturation of the toe and wound		within 4 days of intervention
Secondary	Changes in partial transcutaneous oxygen pressure of the wound region		within 4 days of intervention
Secondary	Changes in foot skin temperature		within 4 days of intervention
Secondary	Changes of C reactive protein- and leukocyte-concentration in serum		within 4 days of intervention
Secondary	Tolerance of stimulation	Tolerance of stimulation is assessed by survey.	within 4 days of intervention
Secondary	Perception of Stimulation	Perception of stimulation is assessed by survey.	within 4 days of intervention
Secondary	Adverse effects of stimulation		within 4 days of intervention