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

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ClinicalTrials.gov Identifier: NCT02221466
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Ole Hyldegaard, Rigshospitalet, Denmark

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).

Condition or disease
Diabetic Peripheral Vascular Disease

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 Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort
diabetic patients
Diabetic patients given HBOT
None diabetic patients
None diabetic patients given HBOT



Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Whole blood and serum.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Diabetic and none diabetic patients admitted for HBOT.
Criteria

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

Information from the National Library of Medicine

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


Locations
Denmark
University Hospital of Copenhagen - Rigshospitalet
Copenhagen, Capitol Region, Denmark, 2100
Sponsors and Collaborators
Ole Hyldegaard
Investigators
Principal Investigator: Ole Hyldegaard, MD, DMSci University Hospital Copenhagen, Rigshospitalet

Publications:

Responsible Party: Ole Hyldegaard, Associate Professor, Medical Director, MD, Ph.D, DMSci, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02221466     History of Changes
Other Study ID Numbers: ENDOPAT-1-HBO-MH-2014
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017

Keywords provided by Ole Hyldegaard, Rigshospitalet, Denmark:
diabetes
foot
wounds
nitric oxide
endothelium
infection
biological markers
observational study
hyperbaric oxygen
ulcers
cytokines
inflammation

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Diabetic Angiopathies
Diabetic Neuropathies
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases