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

Medical University of Vienna

Status: Completed

Conditions: Chronic Diabetic Foot Ulcers

Treatments: Device: PrimeStim

Study type: Interventional

Funder types: Other

Identifiers

NCT02098447

PS 01/2014

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

auricular vagal nerve stimulation

Experimental group

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.

Treatment:

Device: PrimeStim