Measurement of Endothelial Function With Peripheral Arterial Tonometry in Patients Undergoing Hyperbaric Oxygen Therapy

Completed

• Conditions: Diabetic Peripheral Vascular Disease

• Registration Number: NCT02221466
• Lead Sponsor: Ole Hyldegaard

Brief Summary

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).

Detailed Description

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 Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-08-19
• Study First Submitted QC: 2014-08-19
• Study First Posted: 2014-08-20
• Primary Completion: 2016-01-21
• Study Completion: 2016-01-21
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Diabetic patients with foot ulcer
• None diabetic patients
• Age > 18 years
• Patients referred to hyperbaric oxygen therapy.
• Patients who have given written informed consent to participate in the study

Exclusion Criteria

• Patients who cannot cooperate to participate in the study
• Patients who do not understand or speak Danish or English
• Allergy to the materials used in the experiment.
• Patients < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peripheral arterial tonometry (PAT)	18 weeks	Changes in PAT measurements upon completion of HBOT sessions after 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Nitric oxide and cytokine expression	18 weeks	Measurement of nitric oxide bioavailability and levels of cytokine expression levels in serum after HBOT completion following 12 weeks.

Trial Locations

Locations (1)

University Hospital of Copenhagen - Rigshospitalet; 🇩🇰 Copenhagen, Capitol Region, Denmark