Clinical trial NCT02098447: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Diabetic Foot Ulcers
Keywords: vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Vienna University of Technology
First posted: 2014-03-28
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).


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

Primary outcomes:
measure: change in heart rate variability (HRV) related to physiological state (diabetics/healthy)
timeFrame: within 4 days of intervention
measure: change in local blood perfusion index (BPI) related to physiological state (diabetics/healthy)
timeFrame: within 4 days of intervention
Secondary outcomes:
measure: Change in HRV and local BPI due to distinct stimulation patterns
timeFrame: within 4 days of intervention
measure: Change of local BPI in upper and lower extremities
timeFrame: within 4 days of intervention
measure: Changes in blood pressure
timeFrame: within 4 days of intervention
measure: Changes in respiratory activity
timeFrame: within 4 days of intervention
measure: Changes in oxygen saturation of the toe and wound
timeFrame: within 4 days of intervention
measure: Changes in partial transcutaneous oxygen pressure of the wound region
timeFrame: within 4 days of intervention
measure: Changes in foot skin temperature
timeFrame: within 4 days of intervention
measure: Changes of C reactive protein- and leukocyte-concentration in serum
timeFrame: within 4 days of intervention
measure: Tolerance of stimulation
timeFrame: within 4 days of intervention
measure: Perception of Stimulation
timeFrame: within 4 days of intervention
measure: Adverse effects of stimulation
timeFrame: within 4 days of intervention
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University Clinic for Surgery, Department of Transplantation, Medical University Vienna
Study officials:
affiliation: University Clinic for Surgery, Department of Transplantation, Medical University Vienna
name: Jozsef C Széles, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: