Diabetic Peripheral Vascular DiseaseNCT02221466
Measurement of Endothelial Function With Peripheral Arterial Tonometry in Patients Undergoing Hyperbaric Oxygen Therapy
An observational study of Diabetic Peripheral Vascular Disease, run by Ole Hyldegaard at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Vascular Disease
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to 21 Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic and none diabetic patients admitted for HBOT.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University Hospital of Copenhagen - Rigshospitalet
Copenhagen, Capitol Region, 2100
About this study
Official title: Measurements of Endothelial Function by Means of Peripheral Arterial Tonometry in Diabetic Foot Ulcer 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).
Read the 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.
- Conditions
- Diabetic Peripheral Vascular Disease
- Keywords
- diabetes, foot, wounds, nitric oxide, endothelium, infection, biological markers, observational study, hyperbaric oxygen, ulcers, cytokines, inflammation
- Medical subject headings
- Diabetes Mellitus, Wounds and Injuries, Infections, Ulcer, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| diabetic patients | Diabetic patients given HBOT | |
| None diabetic patients | None diabetic patients given HBOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral arterial tonometry (PAT)
Changes in PAT measurements upon completion of HBOT sessions.
Measured: 6 weeks
Peripheral arterial tonometry (PAT)
Changes in PAT measurements upon completion of HBOT sessions after 12 weeks.
Measured: 18 weeks
Secondary outcomes (2)
Nitric oxide and cytokine expression
Measurement of nitric oxide bioavailability and levels of cytokine expression levels in serum after HBOT completion.
Measured: 6 weeks
Nitric oxide and cytokine expression
Measurement of nitric oxide bioavailability and levels of cytokine expression levels in serum after HBOT completion following 12 weeks.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startFeb 2014
- Primary completion21 Jan 2016
- Study completion21 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ole Hyldegaard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ole Hyldegaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ole Hyldegaard, MD, DMSci, Principal investigator, University Hospital Copenhagen, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221466
- Sponsor's protocol ID
- ENDOPAT-1-HBO-MH-2014
- Status last verified
- Apr 2017
- First submitted
- 19 Aug 2014
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20427683Patvardhan 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.
PubMed 20010335Celermajer 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.
PubMed 1359209Brant 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.
PubMed 23751970Bergstrom 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.
PubMed 24085770Mahmud 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.
PubMed 18346515Moerland 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.
PubMed 22500237Eisenbud 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.
PubMed 22732377Boykin 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.
PubMed 17620739
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurements of Endothelial Function by Means of Peripheral Arterial Tonometry in Diabetic Foot Ulcer Patients Undergoing Hyperbaric Oxygen Therapy.
- ClinicalTrials.gov ID
- NCT02221466
- Acronym / sponsor ID
- ENDOPAT-1-HBO-MH-2014
- Conditions
- Diabetic Peripheral Vascular Disease
- Keywords
- diabetes, foot, wounds, nitric oxide, endothelium, infection, biological markers, observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ole HyldegaardUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 21 Jan 2016 (actual)
- Study completion
- 21 Jan 2016 (actual)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetic patients | – | –Diabetic patients given HBOT |
| None diabetic patients | – | –None diabetic patients given HBOT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic and none diabetic patients admitted for HBOT.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peripheral arterial tonometry (PAT)
Time frame: 6 weeks
Changes in PAT measurements upon completion of HBOT sessions.
Peripheral arterial tonometry (PAT)
Time frame: 18 weeks
Changes in PAT measurements upon completion of HBOT sessions after 12 weeks.
2 secondary outcomes
Nitric oxide and cytokine expression
Time frame: 6 weeks
Nitric oxide and cytokine expression
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Background: PubMed 20427683Londahl 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.
- Background: PubMed 20010335Patvardhan 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.
- Background: PubMed 1359209Celermajer 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.
- Background: PubMed 23751970Brant 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.
- Background: PubMed 24085770Bergstrom 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.
- Background: PubMed 18346515Mahmud 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.
- Background: PubMed 22500237Moerland 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.
- Background: PubMed 22732377Eisenbud 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.
- Background: PubMed 17620739Boykin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole Hyldegaard, MD, DMSci principal investigator
University Hospital Copenhagen, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Peripheral Vascular Disease, run by Ole Hyldegaard at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral arterial tonometry (PAT) (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02221466, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.