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

N/ACompletedNCT02098447

Medical University of Vienna24 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Chronic Diabetic Foot Ulcers

Interventions

PrimeStimDEVICE

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Vienna, Vienna, Austria

Outcomes

Primary Outcomes

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.