Overview

This trial is active, not recruiting.

Condition chronic diabetic foot ulcers
Treatment primestim
Sponsor Medical University of Vienna
Collaborator Vienna University of Technology
Start date February 2014
End date December 2015
Trial size 20 participants
Trial identifier NCT02098447, PS 01/2014

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(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.
primestim

Primary Outcomes

Measure
change in heart rate variability (HRV) related to physiological state (diabetics/healthy)
time frame: within 4 days of intervention
change in local blood perfusion index (BPI) related to physiological state (diabetics/healthy)
time frame: within 4 days of intervention

Secondary Outcomes

Measure
Change in HRV and local BPI due to distinct stimulation patterns
time frame: within 4 days of intervention
Change of local BPI in upper and lower extremities
time frame: within 4 days of intervention
Changes in blood pressure
time frame: within 4 days of intervention
Changes in respiratory activity
time frame: within 4 days of intervention
Changes in oxygen saturation of the toe and wound
time frame: within 4 days of intervention
Changes in partial transcutaneous oxygen pressure of the wound region
time frame: within 4 days of intervention
Changes in foot skin temperature
time frame: within 4 days of intervention
Changes of C reactive protein- and leukocyte-concentration in serum
time frame: within 4 days of intervention
Tolerance of stimulation
time frame: within 4 days of intervention
Perception of Stimulation
time frame: within 4 days of intervention
Adverse effects of stimulation
time frame: within 4 days of intervention

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

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

Additional Information

Official title Evaluation of Electrical Auricular Vagal Nerve Stimulation Effects on Parameters of Wound Healing in Chronic Diabetic Wounds - Pilot Study
Principal investigator Jozsef C Széles, Dr.med.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Medical University of Vienna.