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NCT Number: NCT02221466

Measurement of Endothelial Function With Peripheral Arterial Tonometry in 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).

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Key information

Conditions

Diabetic Peripheral Vascular Disease Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Infections Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ulcer Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Copenhagen - Rigshospitalet

Copenhagen, Capitol Region, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Peripheral arterial tonometry (PAT)

    Time frame: 6 weeks

    Changes in PAT measurements upon completion of HBOT sessions.

  2. Peripheral arterial tonometry (PAT)

    Time frame: 18 weeks

    Changes in PAT measurements upon completion of HBOT sessions after 12 weeks.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Ole Hyldegaard

Other

Registry information

Official study title

Measurements of Endothelial Function by Means of Peripheral Arterial Tonometry in Diabetic Foot Ulcer Patients Undergoing Hyperbaric Oxygen Therapy.

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 20, 2014
Registry last updated
Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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