Decellularised Dermis Allograft For The Treatment Of Chronic Venous Leg Ulceration

Background: Chronic venous ulceration (CVU) describes a wound in the lower limbs present for at least three months, caused by inefficient drainage of venous blood. This can be due to either a primary failure of the venous system and / or secondary to previous damage, such as that caused by deep venous thrombosis. Chronic venous leg ulcers (CVLUs) affect approximately 1% of the population, with an increased prevalence of up to 4% in those over 65 years of age. Combined with the social expenses due to loss of work and productivity, this results in CVLUs costing up to 2% of the annual healthcare budget in Western societies. This is predicted to increase as a function of the ageing population. Compression bandaging is the gold standard treatment, with the aim of promoting venous drainage and reducing swelling. However, this is very time consuming and can be performed with variable efficacy. Furthermore, the reduction in community nursing numbers has resulted in increasing difficulty for patients to access this service in the community. The current management for CVLUs is therefore not sufficient to care appropriately for this patient population. Skin grafting represents an adjuvant treatment for CVUs that can promote and expedite ulcer healing. By performing an appropriately powered randomised controlled trial, it will be possible to establish whether a decellularised dermis (DCD) allograft is an effective, safe, acceptable and cost-effective treatment adjunct in CVU care. This trial will therefore explore whether the use of a DCD allograft in addition to compression therapy promotes healing in CVLU compared to compression therapy alone. Methods: This is a prospective, randomised, open, pragmatic trial for adults with CVLU randomised to either dCELL® Human Dermis allograft plus standard compression therapy (intervention) or standard compression therapy alone (control). The primary outcome measure is the proportion of adults with a healed index ulcer at 12 weeks after randomisation as ascertained by an independent blinded clinical assessor. Secondary outcome measures include time to index ulcer healing, recurrence of healed index ulcer, EQ-5D & CCVUQ questionnaires, patient resource use and cost effectiveness. Results: To detect a 25% difference in the proportion of patients with the index ulcer healed at 12 weeks (assuming a healing rate of 30% in the control group and 55% in the intervention group) and allowing for a 10% loss to follow up with a power of 90% and 5% level of significance, 196 patients are required. The study will include a formal interim analysis using a Lan-DeMets alpha spending approach with Fleming O’Brien boundaries. Conclusion: The trial is ongoing; therefore, conclusions cannot be drawn yet.

Citation

Whittley, S., Davies, A., Onida, S., Lane, T., Epstein, D., Gohel, M., Poskitt, K., Cullum, N., Norrie, J., Bradbury, A., Dhillon, K., Ezeife, E., Chandrasekar, A., & Lomas, R. (2022). Decellularised dermis allograft for the treatment of chronic venous leg ulceration. Phlebology. https://doi.org/10.1177/02683555221110363

DOI

10.1177/02683555221110363

URI

https://hdl.handle.net/20.500.14709/716