AVURT: aspirin versus placebo for the treatment of venous leg ulcers – a Phase II pilot randomised controlled trial

Tilbrook, Helen; Clark, Laura; Cook, Liz; Bland, Martin; Buckley, Hannah; Chetter, Ian; Dumville, Jo C; Fenner, C; Forsythe, Rachael; Gabe, Rhian; Harding, Keith; Layton, Alison; Lindsay, Ellie; McDaid, Catriona; Moffatt, Christine; Rolfe, Debbie; Sbizzera, Illary; Stansby, Gerard; Torgerson, David; Vowden, Peter; Lw, Williams; Hinchliffe, Robert J.

doi:10.3310/hta22550

Cited by 4 publications

(4 citation statements)

References 35 publications

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“…Phase 2 aspirin vs. placebo for the treatment of venous leg ulcers (AVURT) trial conducted in the UK found no effect on VLU healing with a 300 mg aspirin as an adjunct to compression. The quality of evidence is low due to small sample size related to recruitment barriers.…”

Section: Resultsmentioning

confidence: 99%

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Adjuvant therapies in venous leg ulcer management: A scoping review

Team

Chandler

Weller

2019

Wound Repair Regeneration

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Compression therapy is the current evidence-based approach to manage venous leg ulcers (VLU); however, adherence is a major barrier to successful treatment. Combination approaches may relieve the burden of treatment by shortening the time to ulcer healing. This scoping review conducted by Australian researchers aimed to establish the evidence of effectiveness of various adjuvant methods on wound healing and recurrence. Randomized Controlled Trials (RCTs), and Systematic Reviews (SR) and Meta-Analyses (MA) on VLU management approaches published from January 2015 to December 2018 were included in this review. The articles included in the scoping review were grouped according to the management approaches, including (1) pharmaceutical interventions, (2) surgical interventions, (3) topical agents, (4) the use of devices, and (5) other, such as physiotherapy and psychological interventions. Results of this scoping review indicate that there is a limited high-quality evidence of effectiveness in most adjuvant therapies on wound healing and recurrence. Given the lowquality evidence observed in this scoping review for adjuvant treatments, the implication for practice is that current management guidelines be followed. Further rigorous studies have the potential to produce better quality evidence. Quality of evidence can be improved by ensuring large sample sizes of a single etiology wounds, standardizing reporting outcomes, and maintaining detailed and evidence-based protocols in physiological or psychological interventions.

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Section: Resultsmentioning

confidence: 99%

“…Aspirin was considered as an adjuvant therapy due to its anti‐inflammatory action . Three studies are in progress or just finalized results on the effect of aspirin on the VLU healing time …”

Section: Introductionmentioning

confidence: 99%

Adjuvant therapies in venous leg ulcer management: A scoping review

Team

Chandler

Weller

2019

Wound Repair Regeneration

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“…Le ulcere varicose rappresentano circa il 70% delle ulcere degli arti inferiori che giungono all'osservazione ambulatoriale; la loro incidenza è dell'1% nella popolazione occidentale, che sale al 3% negli over 65. 2,4,6 Come è noto in circa il 30% dei casi queste lesioni non guariscono entro 6 mesi e l'identificazione dei fattori di rischio appare cruciale ai fini prognostici. 6 Nonostante i recenti progressi in tema di medicazioni avanzate e wound care, le recidive non sono infrequenti e rappresentano un problema per lo specialista ed il paziente; a tutt'oggi le evidenze della Letteratura indicano che il bendaggio elastocompressivo, in particolare ai livelli più alti di compressione, resta fondamentale per il successo del trattamento, 5,7,8 penalizzato spesso però dall'intolleranza del paziente.…”

Section: Discussioneunclassified

Le ulcere flebostatiche recidive degli arti inferiori: analisi di un’esperienza/Recurrent venous leg ulcers: clinical analysis of an experience

Ponte

Gilardi

et al. 2019

Ital J Wound Care

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Nonostante i recenti progressi in tema di wound care, le ulcere varicose degli arti inferiori restano un problema frequente, con un alto tasso di recidiva. In questo lavoro abbiamo esaminato la storia clinica, la storia chirurgica e le patologie associate di 133 pazienti affetti da ulcera varicosa degli arti inferiori, di cui 56 da ulcera recidiva o plurirecidiva. L’analisi dei fattori di rischio potenziale per recidiva ha evidenziato come la presenza di varici recidive, una pregressa trombosi venosa profonda, problemi ortopedici, interventi ortopedici, l’obesità e un’età inferiore a 60 anni siano fattori di rischio potenziale per una recidiva dell’ulcera. La combinazione di uno più fattori di rischio assume significatività per la possibilità di una recidiva; si passa dal 22,7% in assenza di fattori di rischio al 33% per i pazienti che ne presentano due, fino al 57,5% in presenza di tre fattori di rischio e all’81,3% per quattro o più. L’ulcera varicosa richiede un follow-up stretto del paziente e una terapia elastocompressiva continua, che deve vedere una stretta collaborazione del paziente e un’attenzione specifica ai fattori di rischio. Despite recent advances in wound care, varicose ulcers of lower limbs remain frequent and display a high rate of recurrence. In this paper, we examined the clinical, surgical histories and associated diseases of 133 patients with venous ulcers of the lower limbs, which were recurrent in 56 cases. The analysis of potential risk factors for recurrence showed that the presence of recurrent varicose veins, a previous deep venous thrombosis, orthopedic problems, previous orthopedic procedures, obesity and age lower than 60 are potential risk factors for ulcer recurrence. Furthermore, the association of one or more risk factors increased the likelihood of relapse, from 22.7% with no risk factors to 33% with 2 risk factors, up to 57.5% with 3 risk factors, and up to 81.3% with 4 risk factors or more. Venous ulcers require close follow-up and continuous elastic compression, close collaboration by the patient and specific focus on risk factors.

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“…The results from the primary outcome analysis are also presented. The full results are reported in the HTA report, which is available on NIHR’s online Journal Library (https://www.journalslibrary.nihr.ac.uk/) [14].…”

Section: Introductionmentioning

confidence: 99%

Aspirin versus placebo for the treatment of venous leg ulcers—a phase II, pilot, randomised trial (AVURT)

Tilbrook

Cook

Clark

et al. 2019

Trials

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Background Venous leg ulcers (VLUs) can take many months to heal and 25% fail to heal. The main treatment for venous leg ulcers is compression therapy and few additional therapies exist. Two previous trials indicated that low-dose aspirin may improve healing time, but these trials were insufficiently robust. Methods A multi-centred, pilot, phase II, randomised, double blind, parallel-group, placebo-controlled, efficacy trial (RCT) was conducted to determine: if aspirin improves VLU healing time; the safety of aspirin in this population; treatment compliance; and the feasibility of recruitment to a phase III trial. We recruited patients from secondary care who were aged ≥ 18 years, had a chronic VLU and not regularly taking aspirin. Participants were randomly assigned (1:1) to receive 300 mg of daily aspirin or placebo in addition to standard care, which consisted of multi component compression therapy aiming to deliver 40 mmHg at the ankle where possible. The randomisation list was stratified by ulcer size (≤ 5 cm 2 or > 5 cm 2 ). The primary endpoint was time to ulcer healing, which was defined as ‘complete epithelial healing in the absence of scab (eschar) with no dressing required’. Safety outcomes were assessed in all participants who received at least one dose of the study drug. Results Twenty-seven patients were recruited from eight sites (target 100 patients). A short time-frame to recruit and a large number of patients failing to meet the eligibility criteria were the main barriers to recruitment. There was no evidence of a difference in time to healing of the reference ulcer following adjustment for log ulcer area and duration (hazard ratio 0.58, 95% confidence interval 0.18 to 1.85; p = 0.357). One expected serious adverse event related to aspirin was recorded. A number of options to improve recruitment were explored. Conclusions There was no evidence that aspirin was effective in expediting the healing of chronic VLUs. However, the analysis was underpowered due to the low number of participants recruited. The trial design would require substantial amendment in order to progress to a phase III (effectiveness) trial. Trial registration Clinicaltrials.gov, NCT02333123 . Registered on 5 November 2014.

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AVURT: aspirin versus placebo for the treatment of venous leg ulcers – a Phase II pilot randomised controlled trial

Cited by 4 publications

References 35 publications

Adjuvant therapies in venous leg ulcer management: A scoping review

Adjuvant therapies in venous leg ulcer management: A scoping review

Le ulcere flebostatiche recidive degli arti inferiori: analisi di un’esperienza/Recurrent venous leg ulcers: clinical analysis of an experience

Aspirin versus placebo for the treatment of venous leg ulcers—a phase II, pilot, randomised trial (AVURT)

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