O'Reilly 2011.

Trial name or title	Hyperbaric Oxygen Therapy (HBOT) for Chronic Diabetic Lower Limb Ulcers
Methods	Randomised controlled trial
Participants	People with diabetes and a non‐healing lower limb ulcer
Interventions	Patients allocated to active HBOT receive 90 minutes of oxygen at 2.4 ATA with the patients breathing 100% oxygen when inside the chamber. Those patients randomised to placebo will be compressed on air to 0.3 ATA (10 feet) and kept at that level. The patient will remain in the chamber for the remainder of the placebo treatment breathing normally. At the end of the treatment, after a short period of enhanced ventilation (to simulate surfacing) the chamber will be opened. Patients enter the chambers 5 days per week for approximately 6 weeks for a total of 30 treatments. At the end of the 6‐week treatment phase, patients enter a 6‐week follow‐up phase.
Outcomes	The primary outcome in this study is freedom from having, or meeting the criteria for, a major amputation (below knee amputation or metatarsal level) up to 12 weeks after initiation of treatment. Wound healing Effectiveness Safety Healthcare resource utilisation Quality of life Cost effectiveness of HBOT
Starting date	April 2008. Estimated completion Jan 2012.
Contact information	Wilhelmine Jones, Reg. Nurse. 1‐416‐223‐6600. willie.jones@uhn.on.ca
Notes	ClinicalTrials.gov Identifier: NCT00621608