“The goal needs to remain on improving healing, but also reduced recurrence in the long term,” said Stephen Black (Guy’s and St Thomas’ Hospital, London, UK), during his presentation of results from the Leg Ulcer Pathway Audit (LUPA) study at The VEINS, a special programme of the 2019 Vascular Interventional Advances conference (VIVA; 4–7 November, Las Vegas, USA). The investigation showed that a significantly higher percentage of patients treated as part of the leg ulcer pathway went on to healing, compared with standard of care alone.
Speaking to those in attendance, Black pointed to the fact that there is an existing problem with leg ulcer care, with referral practices for patients suffering with these wounds considered to be poor. Furthermore, there is “a general lack of clarity on what treatment is needed”, while the pathophysiology and pathways for leg ulcer patients are also poorly understood.
Although it has been revealed that early intervention significantly improves the rate of healing, based on the results of the EVRA trial, questions have been raised by this study. “Ninety-three percent of patients were excluded with the high screen failure rates,” Black reflected, “while the role of deep venous intervention was unclear, as was the treatment for larger ulcers”.
Standard of care in the local area around Guy’s and St Thomas’ Hospital, described by Black as “a community-based care model”, was evaluated. The speaker commented that there were multiple different models in place and “very little consistency”. A random selection of 100 patients were monitored, and of these patients just 21% healed. Alternatively, 76% had not healed or experienced recurrence.
In response to these findings, the LUPA study was established to compare patient outcomes with an accelerated ulcer care pathway to standard of care only. Black further explained the study rationale: “As part of the LUPA study, we looked at a cohort of consecutive patients (all comers) who underwent the accelerated ulcer care pathway. We also looked at the epidemiology of patients’ ulcers to see what the components of deep, superficial and arterial disease there were, as well as barriers to implementation. This is what we would compare to the standard of care pathway that I have already mentioned.”
Of the 130 patients enrolled, 110 were followed up out to 12 months; 15 were lost to follow-up, while five were excluded from evaluation due to disease or other illnesses that were not viewed to be valid comparators. As Black outlined, 75 of the 110 patients were male (68%) and there was an average age in the cohort of 59 years. Moreover, 53 of the patients (48%) had an ulcer that was more than 12 months old.
It was shown by Black that a majority of the patients (54%) had a history of deep vein thrombosis, which in the case of some patients occurred a long time before ulceration. Drawing comparison to trials focusing on the prevention of post-thrombotic syndrome (PTS), Black noted: “Ulcers and severe PTS can take a long time to develop, and if we are not following up long enough, we may be missing this potential differentiator for the treatment of patients.”
Those enrolled in the study underwent a range of different treatment strategies, including superficial venous insufficiency (SVI) treatment (61% of patients) and venous stenting (33%). “This probably correlates well with rate of previous DVT among the patients,” argued Black, “suggesting that iliac outflow obstruction may play a role in these big, long-standing ulcers that have been there for more than 12 months”.
In the accelerated pathway after 12 months, 80% of the ulcers treated had healed, with a further 11% of patients on their way to healing. Nine percent of patients had not healed, though Black emphasised that this was not surprising as the type of wounds looked at in the study were large and complex ulcers.
Looking ahead at the next step of this investigation, Black concluded: “I have one hospital in central London, which means the data and the demographics studied may not be representative of the whole country. In order to validate these results, we have gone to Oxford with my colleague Emma Wilton, and Cambridge with Manj Gohel, to look at a mixture of urban and rural populations, ensuring that this trend does stack up.”
“We of course want to do further analysis to really understand the healing signals in some of these patients as well, because what was obvious for us was that we need to identify who is going to benefit from deep venous intervention versus superficial, and what adjunctive treatments are necessary.”