Risk factors for the recurrence of venous leg ulcers in adults: A systematic review protocol.

BACKGROUND: Venous leg ulcers are slow to heal, and recurrence is frequent. Living with venous leg ulcers can affect physical and psychological health, and result in financial burden for individuals. Physiological and psychosocial factors are associated with venous leg ulcer recurrence. As over 50% of venous leg ulcers will recur within 12 months of healing, a comprehensive knowledge of holistic risk factors associated with recurrence is required by health professionals involved in the care of the person with venous leg ulcers. AIM: To develop a systematic review protocol to determine the risk factors for recurrence of venous leg ulcers in adults. METHOD AND ANALYSIS: This protocol was developed according to the Preferred Reporting Items Form Systematic Review and Meta-Analysis Protocols (PRISMA-P). The inclusion criteria will be based on the PICOS mnemonic-adults with a history of venous leg ulcer/s (participants), risk factor/s under physiological (general/medical), clinical, demographics, psychosocial categories (I (intervention) or E (exposure), venous leg ulcer non-recurrence (comparison group), venous leg ulcer recurrence (outcomes to be measured) and will include study designs of original qualitative, quantitative and mixed method studies (study designs to be included). Methodological quality will be assessed using the Mixed Methods Appraisal Tool. This Systematic Review Protocol was registered in PROSPERO [CRD42021279792]. RESULTS: If meta-analysis is not possible, a narrative review of results will be presented. CONCLUSIONS: This systematic review on recurrence of venous leg ulcers can provide evidence-based information for preventive strategies for recurrence of a healed venous leg ulcer. The standardised approach outlined in this systematic review protocol offers a rigorous and transparent method to conduct the review.

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

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.