NCT02098447

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2015

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

March 20, 2014

Last Update Submit

March 30, 2017

Conditions

Chronic Diabetic Foot Ulcers

Keywords

vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion

Outcome Measures

Primary Outcomes (2)

  • 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.

    within 4 days of intervention

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

    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.

    within 4 days of intervention

Secondary Outcomes (11)

  • Change in HRV and local BPI due to distinct stimulation patterns

    within 4 days of intervention

  • Change of local BPI in upper and lower extremities

    within 4 days of intervention

  • Changes in blood pressure

    within 4 days of intervention

  • Changes in respiratory activity

    within 4 days of intervention

  • Changes in oxygen saturation of the toe and wound

    within 4 days of intervention

  • +6 more secondary outcomes

Study Arms (1)

auricular vagal nerve stimulation

EXPERIMENTAL

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.

Device: PrimeStim

Interventions

PrimeStimDEVICE
auricular vagal nerve stimulation

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diabetes mellitus type 2
  • ulcus cruris (plantar)
  • min. 6 weeks of standard wound therapy without success
  • intact big toe on wound side

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vienna, Vienna, 1090, Austria

Location

Study Officials

  • Jozsef C Széles, Dr.med.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.med.

Study Record Dates

First Submitted

March 20, 2014

First Posted

March 28, 2014

Study Start

February 1, 2014

Primary Completion

April 13, 2015

Study Completion

April 13, 2015

Last Updated

March 31, 2017

Record last verified: 2017-03

Locations

AU(1)