UrgoStart for treating diabetic foot ulcers and leg ulcers

4.1 The committee concluded that the EXPLORER study provided convincing evidence that UrgoStart dressings improve complete wound healing in patients with diabetic foot ulcers. It noted the external assessment centre (EAC) conclusions that there was a low risk of bias in this study, and that the reported benefits associated with UrgoStart were also supported by the pooled analysis of non-comparative observational data. Although most of the evidence came from patients with neuro-ischaemic ulcers, a clinical expert advised that similar care is used for both neuropathic and neuro-ischaemic diabetic foot ulcers. The committee concluded that the use of UrgoStart, when used as part of overall management, improves wound healing in people with diabetic foot ulcers.

4.2 The committee concluded that the results of the CHALLENGE study showed an increase in the rate of early wound healing with UrgoStart in patients with venous leg ulcers compared with standard treatment. It noted, however, that the study period of 8 weeks was relatively short, and that the observed treatment benefit was based on measuring increased wound area reduction rather than complete wound closure. The clinical experts confirmed that rapid wound area reduction in the first 8 weeks is a good surrogate for ultimately complete wound closure, but that this is not definitive. The experts stated that venous leg ulcers typically heal completely within 18 to 24 weeks. The committee noted the EAC conclusion that there was a low risk of bias in this study, and also that the benefits associated with UrgoStart were supported by the observational data. It concluded that UrgoStart improves wound healing in venous leg ulcers when used as part of overall management including compression therapy, although it was uncertain if this would be translated into complete wound closure.

4.3 The committee recognised how severely diabetic foot and venous leg ulcers affect people's quality of life. However, it concluded that there was limited published evidence to support any quality-of-life benefits directly as a result of using UrgoStart. The clinical experts explained that increases in wound closure and in the rate of wound area reduction are likely to be associated with improvements in day-to-day living. For people with diabetic foot ulcers, complete wound closure is usually necessary for them to return to unhindered walking. For people with venous leg ulcers, a reduction in the wound area may translate into important benefits including earlier transition to less cumbersome dressings and treatment in the community. The experts' comments were corroborated by a small sample of people who have used UrgoStart dressings and reported quality-of-life benefits associated with improved wound healing. The committee concluded that it was plausible that UrgoStart leads to benefits that are important in improving day-to-day living in people with diabetic foot or venous leg ulcers.

4.4 Only a small proportion of the patients with diabetic foot ulcers in the EXPLORER study were recruited from a UK centre. There were no patients from the UK in any of the studies that investigated the benefits of UrgoStart in patients with leg ulcers. Clinical experts stated that the demographics of patients and the fundamentals of wound care are likely to be similar across Europe. However, the experts also explained that some differences in care may exist including, for example, the type of health professional giving the treatment and the compression pressure used to treat venous leg ulcers. The committee concluded that the evidence for UrgoStart was broadly generalisable to the NHS.

4.5 The committee noted that most of the evidence of UrgoStart providing benefit in patients with leg ulcers was specifically for venous leg ulcers. The clinical experts confirmed that about 70% of leg ulcers are caused by venous disease. They also stated that compression is an important part of standard care for venous leg ulcers, but that treatment of non-venous leg ulcers relies on dressings alone. The committee concluded that even though it is plausible that there are benefits from using UrgoStart for non-venous leg ulcers, there was insufficient evidence to make a definitive recommendation about the use of UrgoStart in this group.

4.6 The clinical experts explained that diabetic foot care, including ulcer management, varies across the NHS. Diabetic foot care usually involves a multi-disciplinary team; patients move between GP practice, secondary care and community care depending on their needs. Venous leg ulcers, on the other hand, are mostly treated in a community setting. New and novel dressings are usually incorporated into local care pathways through their inclusion in dressing formularies. The committee did not consider that the use of UrgoStart should be restricted to any particular setting in the NHS, but understood that the decision to use it would usually be made by a multi-disciplinary team or a tissue viability specialist.

4.7 The clinical experts confirmed that UrgoStart would only be used after a thorough wound and patient assessment, and after interventions to control other modifiable factors including debridement and treatment of wound infection. The experts also agreed that if using UrgoStart dressings did not lead to progress in wound healing, they would change to a different product. The committee concluded that UrgoStart should be recommended for patients with non-infected diabetic foot ulcers or venous leg ulcers.

4.8 The committee expressed concerns about the variability seen in wound healing rates, and questioned whether this was correctly reflected in the models. The EAC explained that it had calibrated the models to better reflect this, recognising that not all wounds will improve with treatment and in these instances UrgoStart would be replaced by a different dressing (6.09 weeks for diabetic foot ulcers and 8.26 weeks for venous leg ulcers). The calibration process included using data from the Guest et al. (2018a) and Guest et al. (2018b) papers, which summarised resource-use data taken from an electronic database of patients in 562 GP practices across the UK. These data were used to estimate the proportion of patients whose ulcers had not healed after 1 year in the comparator arms of both analyses. The committee agreed that the EAC's updated models were most appropriate for decision making.

4.9 The committee noted the importance of healing-rate parameters in the cost modelling. It was confident that UrgoStart improved complete wound healing, but was uncertain about the reliability of using an extrapolation method to derive complete wound healing rates from partial healing at 8 weeks in people with venous leg ulcers. In view of this, the committee concluded that the estimates of cost savings are likely to be robust when UrgoStart is used to treat diabetic foot ulcers, but that uncertainty remains about the cost savings when UrgoStart is used to treat venous leg ulcers.

4.10 The EAC's did deterministic sensitivity analyses that varied parameters in both cost models. Results showed that the technology remained cost saving in most cases. The committee concluded that, based on the published evidence, cost modelling and expert opinion, UrgoStart is likely to be cost saving compared with non-interactive dressings. For diabetic foot ulcers, the committee agreed with the estimate from the EAC's updated model of a £342 saving per patient per year with UrgoStart. For venous leg ulcers, it accepted that use of UrgoStart is likely to be cost saving but considered any estimates to be less certain, because of the uncertainty in the evidence for complete wound healing.