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The effectiveness of hyperbaric oxygen therapy for healing chronic venous leg ulcers: a randomized, double-blind, placebo-controlled trial

Citation

Thistlethwaite, KR and Finlayson, KJ and Cooper, PD and Brown, B and Bennett, MH and Kay, G and O'Reilly, MT and Edwards, HE, The effectiveness of hyperbaric oxygen therapy for healing chronic venous leg ulcers: a randomized, double-blind, placebo-controlled trial, Wound Repair and Regeneration, 26, (4) pp. 324-331. ISSN 1067-1927 (2018) [Refereed Article]

Copyright Statement

Copyright 2018 Wound Healing Society

DOI: doi:10.1111/wrr.12657

Abstract

Over 30% of venous leg ulcers do not heal despite evidence-based treatment. This study aimed to determine the effectiveness of Hyperbaric Oxygen Therapy (HBOT) as an adjunct treatment for nonhealing venous leg ulcers. A randomized, double-blind, parallel group, placebo-controlled trial was undertaken in three hyperbaric medicine units. Adults with a venous leg ulcer, Transcutaneous Oxygen Measurement indicative of a hypoxic wound responsive to oxygen challenge, and without contraindications for HBOT; were eligible. Of 84 eligible patients, 10 refused and 74 enrolled. 43 participants achieved over 50% ulcer Percent Area Reduction (PAR) after four weeks of evidence-based care and were thus excluded from the intervention phase. Thirty-one participants were randomized to either 30 HBOT treatments (100% oxygen at 2.4 atmospheres absolute (ATA) for 80 minutes), or 30 "placebo" treatments, receiving a validated "sham" air protocol, initially pressurized to 1.2ATA, then cycled between 1.05-1.2ATA for eight minutes before settling at 1.05ATA. The primary outcome was numbers in each group completely healed. Secondary outcomes were ulcer PAR, pain and quality of life, 12 weeks after commencing interventions. The participants' mean age was 70 years (standard deviation (SD) 12.9) and median ulcer duration at enrolment was 62 weeks (range 4-3120). At 12 weeks, there was no significant difference between groups in the numbers completely healed. The HBOT intervention group had a mean of 95 (SD 6.53) ulcer PAR, compared to 54 (SD 67.8) mean PAR for the placebo group (t = -2.24, p = 0.042, mean difference -40.8, SE 18.2) at 12 weeks. HBOT may improve refractory healing in venous leg ulcers, however patient selection is important. In this study, HBOT as an adjunct treatment for nonhealing patients returned indolent ulcers to a healing trajectory.

Item Details

Item Type:Refereed Article
Keywords:hyperbaric oxygen therapy, leg ulcers, HBOT, hyperbaric medicine
Research Division:Medical and Health Sciences
Research Group:Clinical Sciences
Research Field:Emergency Medicine
Objective Division:Expanding Knowledge
Objective Group:Expanding Knowledge
Objective Field:Expanding Knowledge in the Medical and Health Sciences
UTAS Author:Cooper, PD (Dr David Cooper)
ID Code:131385
Year Published:2018
Web of Science® Times Cited:5
Deposited By:Medicine
Deposited On:2019-03-15
Last Modified:2019-04-26
Downloads:0

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