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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-04-13

Brief Summary

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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).

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Detailed Description

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Conditions

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Chronic Diabetic Foot Ulcers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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auricular vagal nerve stimulation

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.

Group Type EXPERIMENTAL

PrimeStim

Intervention Type DEVICE

Interventions

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PrimeStim

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes