Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-02-20 @ 5:49 PM
Study NCT ID:
NCT02221466
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
2014-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Endothelial Function With Peripheral Arterial Tonometry in Patients Undergoing Hyperbaric Oxygen Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014456', 'term': 'Ulcer'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood and serum.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-27', 'studyFirstSubmitDate': '2014-08-19', 'studyFirstSubmitQcDate': '2014-08-19', 'lastUpdatePostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peripheral arterial tonometry (PAT)', 'timeFrame': '6 weeks', 'description': 'Changes in PAT measurements upon completion of HBOT sessions.'}, {'measure': 'Peripheral arterial tonometry (PAT)', 'timeFrame': '18 weeks', 'description': 'Changes in PAT measurements upon completion of HBOT sessions after 12 weeks.'}], 'secondaryOutcomes': [{'measure': 'Nitric oxide and cytokine expression', 'timeFrame': '6 weeks', 'description': 'Measurement of nitric oxide bioavailability and levels of cytokine expression levels in serum after HBOT completion.'}, {'measure': 'Nitric oxide and cytokine expression', 'timeFrame': '18 weeks', 'description': 'Measurement of nitric oxide bioavailability and levels of cytokine expression levels in serum after HBOT completion following 12 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'foot', 'wounds', 'nitric oxide', 'endothelium', 'infection', 'biological markers', 'observational study', 'hyperbaric oxygen', 'ulcers', 'cytokines', 'inflammation'], 'conditions': ['Diabetic Peripheral Vascular Disease']}, 'referencesModule': {'references': [{'pmid': '20427683', 'type': 'BACKGROUND', 'citation': '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': '20010335', 'type': 'BACKGROUND', 'citation': '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': '1359209', 'type': 'BACKGROUND', 'citation': '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': '23751970', 'type': 'BACKGROUND', 'citation': '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': '24085770', 'type': 'BACKGROUND', 'citation': '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': '18346515', 'type': 'BACKGROUND', 'citation': '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': '22500237', 'type': 'BACKGROUND', 'citation': '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': '22732377', 'type': 'BACKGROUND', 'citation': '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': '17620739', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nPeripheral 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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetic and none diabetic patients admitted for HBOT.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetic patients with foot ulcer\n* None diabetic patients\n* Age \\> 18 years\n* Patients referred to hyperbaric oxygen therapy.\n* Patients who have given written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Patients who cannot cooperate to participate in the study\n* Patients who do not understand or speak Danish or English\n* Allergy to the materials used in the experiment.\n* Patients \\< 18 years'}, 'identificationModule': {'nctId': 'NCT02221466', 'briefTitle': 'Measurement of Endothelial Function With Peripheral Arterial Tonometry in Patients Undergoing Hyperbaric Oxygen Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Measurements of Endothelial Function by Means of Peripheral Arterial Tonometry in Diabetic Foot Ulcer Patients Undergoing Hyperbaric Oxygen Therapy.', 'orgStudyIdInfo': {'id': 'ENDOPAT-1-HBO-MH-2014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'diabetic patients', 'description': 'Diabetic patients given HBOT'}, {'label': 'None diabetic patients', 'description': 'None diabetic patients given HBOT'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Capitol Region', 'country': 'Denmark', 'facility': 'University Hospital of Copenhagen - Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Ole Hyldegaard, MD, DMSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Copenhagen, Rigshospitalet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ole Hyldegaard', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Medical Director, MD, Ph.D, DMSci', 'investigatorFullName': 'Ole Hyldegaard', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}