An observational study in Diabetic Peripheral Vascular Disease, sponsored by Ole Hyldegaard. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-28.
Sponsored by Ole Hyldegaard · Observational
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.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's enrollment of 45 is below the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Ole Hyldegaard is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Diabetic and none diabetic patients admitted for HBOT.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diabetic patients given HBOT
None diabetic patients given HBOT
Peripheral arterial tonometry (PAT)
Changes in PAT measurements upon completion of HBOT sessions.
Time frame: 6 weeks
Peripheral arterial tonometry (PAT)
Changes in PAT measurements upon completion of HBOT sessions after 12 weeks.
Time frame: 18 weeks
Nitric oxide and cytokine expression
Measurement of nitric oxide bioavailability and levels of cytokine expression levels in serum after HBOT completion.
Time frame: 6 weeks
Nitric oxide and cytokine expression
Measurement of nitric oxide bioavailability and levels of cytokine expression levels in serum after HBOT completion following 12 weeks.
Time frame: 18 weeks
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Ole Hyldegaard