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

Last updated: March 30, 2017
Sponsor: Medical University of Vienna
Overall Status: Completed

Phase

N/A

Condition

Ulcers

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT02098447
PS 01/2014
  • Ages 40-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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

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, exceptdiabetic concomitant diseases (e.g., polyneuropathy, angiopathy)

  • drug abuse

  • active implanted devices

  • pregnancy or nursing

Study Design

Total Participants: 24
Study Start date:
February 01, 2014
Estimated Completion Date:
April 13, 2015

Connect with a study center

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

    Vienna, 1090
    Austria

    Site Not Available

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