None listed
Conditions
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.
Interventions
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 the
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.
Sponsors
Collaborate Sponsorship: Wesley Centre for Hyperbaric Medicine, Queensland University of Technology, and the Wound Management Innovation CRC
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed