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

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.

Potential markers of healing from near infrared spectroscopy imaging of venous leg ulcer. A randomized controlled clinical trial comparing conventional with hyperbaric oxygen treatment

“…More direct support comes from the work of Hammarlund et al 27 where it was shown the beneficial effect of HBOT in reducing wound size of VLU vis‐à‐vis a control group exposed to hyperbaric air. Similar results have been obtained recently by Thistlethwaite et al 28 However, despite these favorable findings, HBOT is not being used routinely in the management of VLU, since the evidence base is limited. The causal reasons for the response of the underlying biological processes of wound repair to HBOT are still unclear and, consequently, current protocols remain empirical 29 .…”

“…Wicke et al reported a success rate of at least 90% when the surface of the wound shows a reduction in excess of 80% within the initial 12 weeks of treatment 44 . In addition, according to Thistlewaite et al, the failure to meet a 50% reduction after 4 weeks of conventional therapy should be taken as a criterion for initiating a HBOT adjuvant intervention 28 . Our work, however, sets on firmer ground the feasibility to predict a healing course for VLU.…”

Breathing life into engineered tissues using oxygen-releasing biomaterials

“…Conventional therapies, such as hyperbaric oxygen therapy, have been used to treat a variety of open wound types, including diabetic ulcers. In combination with other current treatments, these methods in medical practice have shown therapeutic benefits 69,[84][85][86][87] . Oxygenreleasing materials have been employed in wound healing applications in the form of fluorinated methacrylamide chitosan and biodegradable hydrogels 79 .…”

<p>Hyperbaric oxygen therapy for the management of chronic wounds: patient selection and perspectives</p>

“…HBO 2 has been found to reduce wound surface area following therapy in two randomized, sham controlled trials, but neither showed an improvement in healing rates. 164,165 A third study did show statistically significant wound healing with HBO 2 . 166 There is insufficient evidence to support the routine use of HBO 2 in the treatment of VLUs.…”