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Completed

NCT Number: NCT02098447

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

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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Key information

Conditions

Chronic Diabetic Foot Ulcers

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PrimeStim

Device

Primary outcomes

  1. change in heart rate variability (HRV) related to physiological state (diabetics/healthy)

    Time frame: within 4 days of intervention

    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.

  2. change in local blood perfusion index (BPI) related to physiological state (diabetics/healthy)

    Time frame: within 4 days of intervention

    Blood perfusion index at the foot will be assessed as peak-peak amplitude (systolic to diastolic) divided by the mean signal value of optically measured blood perfusion.

    Changes in mean value and standard deviation of local blood perfusion index between healthy and diabetic patients will be assessed using statistical tests.

Secondary outcomes

  1. Change in HRV and local BPI due to distinct stimulation patterns

    Time frame: within 4 days of intervention

    Two distinct stimulation patterns are tested during intervention.

    Changes in mean value and standard deviation of HRV/BPI due to these stimulation patterns will be assessed using statistical tests.

  2. Change of local BPI in upper and lower extremities

    Time frame: within 4 days of intervention

    Local BPI is assessed using optical sensors on the foot and the finger of participants.

    Changes in mean value of BPI are analyzed using statistical tests.

  3. Changes in blood pressure

    Time frame: within 4 days of intervention

    Blood pressure is continuously measured using inflatable finger cuffs.

  4. Changes in respiratory activity

    Time frame: within 4 days of intervention

    Respiratory activity is monitored using a respiratory belt.

  5. Changes in oxygen saturation of the toe and wound

    Time frame: within 4 days of intervention

  6. Changes in partial transcutaneous oxygen pressure of the wound region

    Time frame: within 4 days of intervention

  7. Changes in foot skin temperature

    Time frame: within 4 days of intervention

  8. Changes of C reactive protein- and leukocyte-concentration in serum

    Time frame: within 4 days of intervention

  9. Tolerance of stimulation

    Time frame: within 4 days of intervention

    Tolerance of stimulation is assessed by survey.

  10. Perception of Stimulation

    Time frame: within 4 days of intervention

    Perception of stimulation is assessed by survey.

  11. Adverse effects of stimulation

    Time frame: within 4 days of intervention

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Vienna University of Technology

Registry information

Official study title

Evaluation of Electrical Auricular Vagal Nerve Stimulation Effects on Parameters of Wound Healing in Chronic Diabetic Wounds - Pilot Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 28, 2014
Registry last updated
Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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