Measurement of Endothelial Function With Peripheral Arterial Tonometry in Patients Undergoing Hyperbaric Oxygen Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02221466|
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : April 28, 2017
|Condition or disease|
|Diabetic Peripheral Vascular Disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||45 participants|
|Official Title:||Measurements of Endothelial Function by Means of Peripheral Arterial Tonometry in Diabetic Foot Ulcer Patients Undergoing Hyperbaric Oxygen Therapy.|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||January 21, 2016|
|Actual Study Completion Date :||January 21, 2016|
Diabetic patients given HBOT
None diabetic patients
None diabetic patients given HBOT
- Peripheral arterial tonometry (PAT) [ Time Frame: 6 weeks ]Changes in PAT measurements upon completion of HBOT sessions.
- Peripheral arterial tonometry (PAT) [ Time Frame: 18 weeks ]Changes in PAT measurements upon completion of HBOT sessions after 12 weeks.
- Nitric oxide and cytokine expression [ Time Frame: 6 weeks ]Measurement of nitric oxide bioavailability and levels of cytokine expression levels in serum after HBOT completion.
- Nitric oxide and cytokine expression [ Time Frame: 18 weeks ]Measurement of nitric oxide bioavailability and levels of cytokine expression levels in serum after HBOT completion following 12 weeks.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221466
|University Hospital of Copenhagen - Rigshospitalet|
|Copenhagen, Capitol Region, Denmark, 2100|
|Principal Investigator:||Ole Hyldegaard, MD, DMSci||University Hospital Copenhagen, Rigshospitalet|