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

NCT02221466 | Completed

• 1 other identifier: ENDOPAT-1-HBO-MH-2014
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetic Peripheral Vascular Disease

Keywords

diabetes; foot; wounds; nitric oxide; endothelium; infection; biological markers; observational study; hyperbaric oxygen; ulcers; cytokines; inflammation

Outcome Measures

Primary Outcomes (2)

• Peripheral arterial tonometry (PAT)

  Changes in PAT measurements upon completion of HBOT sessions.

  6 weeks

• Peripheral arterial tonometry (PAT)

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

  18 weeks

Secondary Outcomes (2)

• Nitric oxide and cytokine expression

  6 weeks

• Nitric oxide and cytokine expression

  18 weeks

Study Arms (2)

diabetic patients

Diabetic patients given HBOT

None diabetic patients

None diabetic patients given HBOT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Diabetic and none diabetic patients admitted for HBOT.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ole Hyldegaard: lead

Study Sites (1)

University Hospital of Copenhagen - Rigshospitalet

Copenhagen, Capitol Region, 2100, Denmark

Location

Related Publications (9)

• Londahl M, Katzman P, Nilsson A, Hammarlund C. Hyperbaric oxygen therapy facilitates healing of chronic foot ulcers in patients with diabetes. Diabetes Care. 2010 May;33(5):998-1003. doi: 10.2337/dc09-1754.

  PMID: 20427683 BACKGROUND

• Patvardhan EA, Heffernan KS, Ruan JM, Soffler MI, Karas RH, Kuvin JT. Assessment of vascular endothelial function with peripheral arterial tonometry: information at your fingertips? Cardiol Rev. 2010 Jan-Feb;18(1):20-8. doi: 10.1097/CRD.0b013e3181c46a15.

  PMID: 20010335 BACKGROUND

• Celermajer DS, Sorensen KE, Gooch VM, Spiegelhalter DJ, Miller OI, Sullivan ID, Lloyd JK, Deanfield JE. Non-invasive detection of endothelial dysfunction in children and adults at risk of atherosclerosis. Lancet. 1992 Nov 7;340(8828):1111-5. doi: 10.1016/0140-6736(92)93147-f.

  PMID: 1359209 BACKGROUND

• Brant LC, Barreto SM, Passos VM, Ribeiro AL. Reproducibility of peripheral arterial tonometry for the assessment of endothelial function in adults. J Hypertens. 2013 Oct;31(10):1984-90. doi: 10.1097/HJH.0b013e328362d913.

  PMID: 23751970 BACKGROUND

• Bergstrom A, Staalso JM, Romner B, Olsen NV. Impaired endothelial function after aneurysmal subarachnoid haemorrhage correlates with arginine:asymmetric dimethylarginine ratio. Br J Anaesth. 2014 Feb;112(2):311-8. doi: 10.1093/bja/aet331. Epub 2013 Oct 1.

  PMID: 24085770 BACKGROUND

• Mahmud FH, Van Uum S, Kanji N, Thiessen-Philbrook H, Clarson CL. Impaired endothelial function in adolescents with type 1 diabetes mellitus. J Pediatr. 2008 Apr;152(4):557-62. doi: 10.1016/j.jpeds.2007.08.044. Epub 2007 Nov 5.

  PMID: 18346515 BACKGROUND

• Moerland M, Kales AJ, Schrier L, van Dongen MG, Bradnock D, Burggraaf J. Evaluation of the EndoPAT as a Tool to Assess Endothelial Function. Int J Vasc Med. 2012;2012:904141. doi: 10.1155/2012/904141. Epub 2012 Feb 14.

  PMID: 22500237 BACKGROUND

• Eisenbud DE. Oxygen in wound healing: nutrient, antibiotic, signaling molecule, and therapeutic agent. Clin Plast Surg. 2012 Jul;39(3):293-310. doi: 10.1016/j.cps.2012.05.001. Epub 2012 Jun 2.

  PMID: 22732377 BACKGROUND

• Boykin JV Jr, Baylis C. Hyperbaric oxygen therapy mediates increased nitric oxide production associated with wound healing: a preliminary study. Adv Skin Wound Care. 2007 Jul;20(7):382-8. doi: 10.1097/01.ASW.0000280198.81130.d5.

  PMID: 17620739 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and serum.

MeSH Terms

Conditions

Diabetes Mellitus; Wounds and Injuries; Infections; Ulcer; Inflammation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ole Hyldegaard, MD, DMSci

  University Hospital Copenhagen, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Medical Director, MD, Ph.D, DMSci

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 20, 2014
• Study Start: February 1, 2014
• Primary Completion: January 21, 2016
• Study Completion: January 21, 2016
• Last Updated: April 28, 2017

Record last verified: 2017-04

Locations

DK (1)