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Trial registered on ANZCTR


Registration number
ACTRN12611000505909
Ethics application status
Approved
Date submitted
1/05/2011
Date registered
16/05/2011
Date last updated
26/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of hyperbaric oxygen therapy (HBOT) for healing venous leg ulcers
Scientific title
The effectiveness of hyperbaric oxygen therapy (HBOT) for healing chronic venous leg ulcers: A randomised, double blind, placebo-controlled trial
Secondary ID [1] 259717 0
WMI CRC 3-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous leg ulcers 261296 0
Condition category
Condition code
Cardiovascular 259444 259444 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Participants will be treated with a multilayered high compression system (gold standard evidence based practice) once per week throughout the duration of the study. Those randomised to Group 1 will receive hyperbaric oxygen therapy (HBOT) treatments. Each HBOT treatment will consist of oxygen at 2.4 atmospheres absolute (ATA) for 110 minutes. Oxygen is pressurised in a cyclical routine through a number of “compression/decompression” phases during the treatment. Patients will receive these HBOT treatment 5 days/week for 6 weeks or until healed, an upper limit of 30 treatments.
Intervention code [1] 264237 0
Treatment: Other
Comparator / control treatment
Group 2: Participants will be treated with a multilayered high compression system (gold standard evidence based practice) once per week throughout the study. Those randomised to Group 2 will receive a sham HBOT treatment. Each sham HBOT treatment will consist of an exact time replica of the treatment protocol using air pressurised to 1.2 ATA then decreased to 1.0 ATA. This is repeated in a cyclical routine through the “compression/decompression” phases of the treatment protocol. The patient is maintained at 1.0 ATA through the 85 minute “treatment” phase. Participants will receive the sham treatment 5 days/week for 6 weeks or until healed, an upper limit of 30 treatments.
Control group
Active

Outcomes
Primary outcome [1] 262350 0
Number of healed ulcers/group. Ulcer area will be calculated using wound tracings, digital photography and digital planimetry to determine area reduction, percent reduction and total healing rates. A healed ulcer is defined as full epithelialisation maintained for at least two weeks.
Timepoint [1] 262350 0
Assessed every week up to 12 weeks from randomisation.
Primary outcome [2] 262351 0
Time to ulcer healing
Timepoint [2] 262351 0
Assessed every week up to 12 weeks from randomisation.
Primary outcome [3] 262352 0
ulcer area percentage reduction in each group
Timepoint [3] 262352 0
Assessed every week up to 12 weeks from randomisation.
Secondary outcome [1] 273609 0
PUSH scores of each group
(Stotts et al. 2001. J Gerontol Biol Sci 56:M795)
Timepoint [1] 273609 0
Assessed every week up to 12 weeks from randomisation.
Secondary outcome [2] 273610 0
Quality of life of each group, measured with:
1. SF-12
2. Medical Outcomes Study Pain Measures
3. Geriatric Depression Scale
Timepoint [2] 273610 0
Upon enrolment in the study and at 12 weeks from randomisation.
Secondary outcome [3] 273611 0
Cost effectiveness of each group will be evaluated by a health economist, utilising measures of the number and costs of health services provided, investigations, dressings and bandages used while unhealed, occasions of care provision and staff time, loss of functional ability and QALYs.
Timepoint [3] 273611 0
At the completion of the study, 12 weeks after the initiation of the HBOT treatments.
Secondary outcome [4] 273612 0
incidence of treatment emergent adverse effects for each group (e.g., ear barotrauma, oxygen toxicity effects such as seizures, myopic visual effects). These side effects are all temporary changes. A nurse is present with patients through all hyperbaric treatments and will check with the patient re whether they have any ear pain or other symptoms and treat and record any adverse effects. Patients will also be asked if they have had any of these symptoms at each study visit.
Timepoint [4] 273612 0
at every HBOT or sham HBOT treatment.

Eligibility
Key inclusion criteria
Persons presenting with a venous leg ulcer that have an Ankle branchial pressure index between 0.8 and 1.2, a TCOM reading that indicates a hypoxic wound responsive to an oxygen challenge, who are not at risk for hyperbaric-related complications and whose ulcer has not responded to standard treatment (i.e., <50% reduction in ulcer area following 4 weeks of treatment.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Persons with cognitive impairment.
2. Persons with an Ankle Branchial Pressure Index <0.8 or >1.2.
3. Persons with leg ulcers of non-venous aetiology.
4. Persons considered to be at specific risk for hyperbaric-related complications, as specified below:
-pregnancy
-concurrent administration of disulfuram, or antineoplastic agents doxorubicin and cisplatinum.
-reactive airway disease (COPD with CO2 retention), radiographic evidence of pulmonary blebs/bullae
-untreated pneumothorax or history of spontaneous pneumothorax
-previous documented ejection fraction less than 35% or cardiovascular instability
-history of seizures - except childhood febrile seizures
-unable to follow simple commands, not orientated to person, place, time.
-prior chest surgery, middle ear surgery, optic neuritis, fever, congenital , spherocytosis, claustrophobia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients presenting with a venous leg ulcer
and fitting the inclusion and exclusion criteria
will be invited to participate in the study. Once
a patient has been identified by the clinician in
charge as fitting the inclusion criteria, the
Research Assistant will approach the patient to
invite them to participate and give them an
information and consent package. If the patient
consents to participate in the study, the
Research Assistant will collect baseline data
from the patient’s records and give the patient
a questionnaire to fill in. Where more than one ulcer is present, a target ulcer will be identified for the purpose of the study (i.e., the largest ulcer).The Research
Assistant will open a randomisation envelope
and the patient will be allocated to either
Treatment group 1 or Treatment group 2. A
staff member not working on this project will
have previously filled sealed opaque envelopes
with the allocation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prior to commencement of the study a
randomisation allocation sequence will be
generated with a computerised randomisation
program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264690 0
Government body
Name [1] 264690 0
Wound Management Innovation Cooperative Research Centre
Address [1] 264690 0
Level 2, 8 Carraway Street
Kelvin Grove QLD 4059
Country [1] 264690 0
Australia
Primary sponsor type
Other
Name
Collaborate Sponsorship: Wesley Centre for Hyperbaric Medicine, Queensland University of Technology, and the Wound Management Innovation CRC
Address
Wound Management Innovation CRC, Level 2, 8 Carraway Street, Kelvin Grove QLD 4059

Wesley Centre for Hyperbaric Medicine, 30 Chasely St
Auchenflower, QLD 4066

School of Nursing & Midwifery, QUT, Victoria Park Rd, Kelvin Grove, QLD 4059
Country
Australia
Secondary sponsor category [1] 264082 0
None
Name [1] 264082 0
Address [1] 264082 0
Country [1] 264082 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266703 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 266703 0
QUT Human Research Ethics Unit
Office of Research
Level 4, 88 Musk Avenue
Kelvin Grove QLD 4059
Ethics committee country [1] 266703 0
Australia
Date submitted for ethics approval [1] 266703 0
Approval date [1] 266703 0
20/12/2010
Ethics approval number [1] 266703 0
1000001172
Ethics committee name [2] 266704 0
Uniting Care Queensland Human Research Ethics Committee
Ethics committee address [2] 266704 0
Level 5
193 North Quay, BRISBANE
QLD
4000
Ethics committee country [2] 266704 0
Australia
Date submitted for ethics approval [2] 266704 0
Approval date [2] 266704 0
02/03/2011
Ethics approval number [2] 266704 0
1102

Summary
Brief summary
This study aims to conduct a blinded, randomised, placebo-controlled trial to determine the effectiveness of hyperbaric oxygen therapy for patients with non-healing venous leg ulcers on progress in wound healing, pain, quality of life and cost effectiveness of care.

Study Therapy:
Active - Oxygen at 2.4 atmospheres absolute for 110 minutes in the Hyperbaric Chamber.
Placebo - Exact time replica of the treatment protocol using air pressurised to 1.2 ATA then decreased to 1.0 ATA. This is repeated in a cyclical routine through the “compression/decompression” phases of the treatment protocol. The patient is maintained at 1.0 ATA through the 85 minute “treatment” phase.

Study Population: Male and female adults with non-healing venous leg ulcers and who fit with the study inclusion/exclusion criteria will be recruited into the study.
To complete 58 study participants in the HBOT blinded study, at least 84 volunteers will need to be enrolled into the four week pre-HBOT treatment assessment period.

No. Centres: 1. Wesley Centre for Hyperbaric Medicine

Study Design: The study has a randomised, double-blind, placebo controlled design.

Study Duration: Total of 16 weeks including the four weeks prior to and six weeks following the HBOT intervention of six weeks duration.

Objectives of the Study: To determine the effectiveness of hyperbaric oxygen therapy for study participants with non-healing venous leg ulcers on progress in wound healing, pain, quality of life and cost effectiveness of care.

Study Endpoints: (Primary and Secondary)
Primary wound healing outcome measure will be the incidence of complete wound closure at the completion of the study (12 weeks after initiation of the HBOT study).
Secondary outcomes will include time to healing, ulcer area percentage reduction and differences in PUSH scores.
The primary safety endpoints will be incidence of treatment emergent adverse events. Study participants are assessed prior to commencing HBOT and then at every treatment for adverse effects e.g. ear barotrauma, oxygen toxicity effects (seizures, myopic visual effects). These side effects are all temporary changes.
Quality of Life data will be measured at the beginning and end of the 16-week study.
Trial website
Trial related presentations / publications
Nil as yet
Public notes

Contacts
Principal investigator
Name 32299 0
Dr Ken Thistlethwaite
Address 32299 0
Royal Brisbane & Women's Hospital
Herston Rd
Herston, Qld, 4059
Country 32299 0
Australia
Phone 32299 0
+61 428683112
Fax 32299 0
Email 32299 0
Kenneth.Thistlethwaite@health.qld.gov.au
Contact person for public queries
Name 15546 0
Dr Dr Ken Thistlethwaite
Address 15546 0
Royal Brisbane & Women's Hospital
Herston Rd
Herston, Qld, 4059
Country 15546 0
Australia
Phone 15546 0
61 7 3371 6033
Fax 15546 0
61 7 3371 1566
Email 15546 0
kenneth.thistlethwaite@health.qld.gov.au
Contact person for scientific queries
Name 6474 0
Dr Dr Ken Thistlethwaite
Address 6474 0
Royal Brisbane & Women's Hospital
Herston Rd
Herston, Qld, 4059
Country 6474 0
Australia
Phone 6474 0
61 7 3371 6033
Fax 6474 0
61 7 3371 1566
Email 6474 0
kenneth.thistlethwaite@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary