Chronic Diabetic Foot Ulcers
Conditions
Keywords
vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion
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).
Interventions
DEVICEPrimeStim
Sponsors
Vienna University of Technology
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in heart rate variability (HRV) related to physiological state (diabetics/healthy) | 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. |
| change in local blood perfusion index (BPI) related to physiological state (diabetics/healthy) | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood pressure | within 4 days of intervention | Blood pressure is continuously measured using inflatable finger cuffs. |
| Changes in respiratory activity | within 4 days of intervention | Respiratory activity is monitored using a respiratory belt. |
| Changes in oxygen saturation of the toe and wound | within 4 days of intervention | — |
| Changes in partial transcutaneous oxygen pressure of the wound region | within 4 days of intervention | — |
| Change in HRV and local BPI due to distinct stimulation patterns | 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. |
| Changes of C reactive protein- and leukocyte-concentration in serum | within 4 days of intervention | — |
| Tolerance of stimulation | within 4 days of intervention | Tolerance of stimulation is assessed by survey. |
| Perception of Stimulation | within 4 days of intervention | Perception of stimulation is assessed by survey. |
| Adverse effects of stimulation | within 4 days of intervention | — |
| Changes in foot skin temperature | within 4 days of intervention | — |
| Change of local BPI in upper and lower extremities | 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. |
Countries
Austria
Outcome results
None listed