Diabetic Peripheral Vascular Disease Clinical Trial
Official title:
Measurements of Endothelial Function by Means of Peripheral Arterial Tonometry in Diabetic Foot Ulcer Patients Undergoing Hyperbaric Oxygen Therapy.
The purpose of this clinical study is to test whether or not patients treated with HBOT for diabetic foot ulcers will demonstrate measurable changes of the blood vessel function during the course of HBOT treatments. , i.e. an expected increase in the reactive hyperemic index (RHI) measured by the peripheral arterial tonometry (PAT).
Measurement and monitoring of endothelial function can be used for prediction of outcome in
acute, severe disease. Diabetic patients have a poorer peripheral vascular function measured
by peripheral arterial tonometry (PAT) as compared to normals, but the effect of hyperbaric
oxygen therapy (HBOT) on endothelial function in these patients is unknown. Measurement of
PAT in patients with diabetic foot ulcers undergoing HBOT, may help to improve treatment and
changes in the reactive hyperemic index (RHI) might correlate with wound healing in these
patients.
Peripheral arterial tonometer (PAT) has been shown to be an easy, fast and standardized
method for measuring the peripheral arterial endothelial function. The method is also
operator-independent and has a high reproducibility.
The PAT apparatus (ENDOPAT) measures the post-ischemic response to a five-minute blood flow
occlusion of the upper arm, and the relationship between the pre-and post-ischemic pulse
amplitude is expressed as a reactive hyperemic index (RHI). The normal RHI in young healthy
persons is more than 2, while in critically ill patients and patients with diabetes,
hypertension or heart disease it is significantly decreased.
The study aims to test whether or not patients treated with HBOT for diabetic foot ulcers
will demonstrate an improvement of the endothelial function in the peripheral vessels, i.e.
an increase in RHI measured by the PAT. Similarly, essential mediators of angiogenesis and
nitric oxide bioavailability will be measured in peripheral blood taken during the PAT
measurements which will be performed at the time of inclusion, before HBOT and subsequently
for each 10th HBOT session.
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