Vulnamin as an adjunct to standard of care in hard-to-heal venous leg ulcers: clinical effectiveness and cost modelling.

Abstract

Objective: This study aimed to evaluate the rate at which Vulnamin (Professional Dietetics S.p.A., Italy), a combination of hyaluronic acid and amino acids, heals hard-to-heal venous leg ulcers (VLUs) by measuring percentage area reduction (PAR), wound bed condition, slough presence, infection, oedema, pain and general ulcer health. It also aimed to model the cost-effectiveness of the product as an adjunct when used alongside standard of care (SoC) of leg ulcers.

Method: Patients with hard-to-heal VLUs were treated with the evaluated adjunct product for up to six weeks. Formulations were prescribed based on ulcer size, depth and levels of slough. Treatments involved both cream and powder formulations as adjunct to SoC. Wound size was measured and photographic evidence was documented throughout. The costing analysis was based on resource utilisation and clinical effectiveness data reported from the service evaluation. The total cost of the evaluated adjunct product over a four week period was calculated to be £813.39.

Results: A total of 20 patients took part in the evaluation. Wound healing spanned 63 days, with an average size at baseline of 6.7cm². By day 7, the wound area had reduced to 5.36cm², by day 14 to 4.93cm², by day 21 to 4.42cm², and by day 35 to 3.4cm². The overall PAR reached 76.26% by day 63, showing consistent improvement. The cumulative costs associated with the evaluated adjunct product over four weeks were £2621.64, compared with the cumulative costs of SoC alone over four weeks of £1323.28. However, if the Vulnamin adjunct costs halt at four weeks, but the costs in the SoC group continue to accumulate, the cost at 111 days (16 weeks and 6 days) for a hard-to-heal wound would be £2622.93, compared to £2621.64 for the Vulnamin adjunct costs. This is the point that the healing cost of the evaluated adjunct product starts to become cost-saving to the UK's National Health Service.

Conclusion: In this study, Vulnamin showed promise in accelerating VLU healing. However, given the small sample size, and given the variability in ulcer characteristics and comorbidities, this underscores the need for further research with a larger, more diverse patient populations to confirm and extend these results. The analysis indicates positive cost-saving results based on the 20 patients within the study. Further research is needed to validate the potential of Vulnamin use in wound care.