Introduction

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Complete healing of venous leg ulcers can take years and recurrence is a problem.¹ Patients experience pain, affecting sleep, mobility, and quality of life.^2-4 The financial cost of venous disease in Britain has been estimated at between £294m and £650m a year. ^{5 6} Most care for people with leg ulcers has been provided by community nurses,⁷ who use numerous treatments, although adequate information about their effect on complete healing or quality of life is not available. ^{6 8}

A unique graduated four layer compression bandaging system was pioneered at Charing Cross Hospital⁹ and clinics in Riverside that used this system achieved a healing rate of 69% of venous ulcers in 12 weeks.¹⁰ Estimates indicated that costs for clinics were lower than for the previous care system.¹¹ The effectiveness, however, remained uncertain, and concern was expressed that this uncontrolled study provided the basis for the introduction of a new leg ulcer service.¹²

A randomised controlled trial was undertaken to compare the effect of four layer bandaging in a clinic setting on healing of venous leg ulcers and health status against the usual home based care provided by district nursing services. The relative cost effectiveness of the two interventions was also evaluated.

	Patients and methods

Recruitment
The study was approved by appropriate ethics committees. Recruitment was from September 1994 to May 1995 in eight clinics (four urban, two suburban, two semirural) in four community trusts in Trent. The inclusion criteria were a venous ulcer below the knee to the foot that was present for at least 3 months and ability to travel to the clinic. Patients were assessed by clinic coordinators using Doppler ultrasound. Those with an ankle brachial pressure index <0.8 were excluded. The nurses all adhered to the standardised clinic protocol. A total of 233 patients provided written informed consent (fig 1). A random assignment schedule and serially numbered, sealed, opaque allocation envelopes were prepared in advance for each of the eight clinic sites.

View larger version (28K): [in this window] [in a new window]   Fig 1.    Diagrammatic representation of sample size

Intervention
The intervention was weekly treatment in a leg ulcer clinic. Clinic coordinators all completed a course on management of leg ulcers (ENB N18) and additional training days to practice applying four layer bandaging (supervised by experienced practitioners). Treatment adhered as closely as possible to the Charing Cross bandaging technique.⁹ After healing, patients were prescribed class 2 compression stockings and were reviewed by the clinic coordinators every 3 months. For the control group, as it was a pragmatic trial, nurses in the home provided the patients' usual treatment.

Outcomes and follow up
The primary clinical end point was time to complete healing of all ulcers within the 12 month follow up period. The nurses recorded the date of healing, defined as re-epithelialisation of all ulcers. Secondary end points were health status, time to first recurrence of a healed ulcer, and the number of weeks the patients were free from ulcers.

Economic evaluation and analysis
The economic analysis was undertaken from an NHS perspective. Total estimated NHS costs per patient were calculated by estimating the cost of treatment for leg ulcers (staff time, materials, transport, and overheads) and the cost of use of other health services (general practitioner contacts and hospital). For the control group data were collected for individual home visits to produce a mean cost per home visit. For the clinic group data on use of resources were available for each clinic session but not on an individual basis. The mean cost per attendance per patient was derived from the total cost per session.

Statistical analysis
Sample sizes were calculated based on the expected difference in rate of healing between the groups after 12 weeks. To have an 80% chance of detecting as significant (at the 5% level) an increase in healing from 50% to 70%, 206 patients were required.

View larger version (13K): [in this window] [in a new window]   Fig 2.    Healing times of initial leg ulcers by treatment group (solid line=control group, n=113; dotted line=clinic group; n=120). Log rank test statistic 4.90; df=1; P=0.03

	Results

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The patients in the two groups were well matched at randomisation with respect to baseline clinical, demographic, and health status measurements (tables 1 and 2). Various treatments were used in the control group (table 3). Access to four layer bandaging for patients in the control group was minimal as all components were not available on prescription.²⁵

There was evidence of a difference in the initial healing times for leg ulcers between the groups over the whole follow up (fig 2) with the clinic group tending to heal sooner (P=0.03). The median healing times were 20 and 43 weeks for patients in the clinic and control groups, respectively. At 12 weeks the Kaplan-Meier estimates of the cumulative percentages healed at 12 weeks were 34% in the clinic group and 24% in the control (difference 10%, 95% confidence interval 2% to 22%).

According to the Cox model the initial ulcer was 1.45 times more likely to heal in the clinic group than in the control group (1.04 to 2.03). After adjustment for the prognostic variables the initial healing rate of clinic versus control patients was 1.65 (1.15 to 2.35).

In the clinic group, 35% (27/78) of patients who initially healed had a recurrence against 23% (14/62) in the control group. Some patients had several episodes of recurrences and rehealing over follow up. There was no evidence of a difference in the time to first recurrence between the groups (log rank test 0.78; df=1; P=0.38).

The mean time (in weeks) that each patient was free from ulcers during follow up was 20.1 and 14.2 in the clinic and control groups, respectively. On average, patients in the clinic group had 5.9 more ulcer free weeks (1.2 to 10.5) than control patients.

Health status and satisfaction
For most dimensions of the SF-36 and EuroQol, health status deteriorated over time, with no difference between the groups. For three dimensions of the SF-MPQ there was evidence that the patients in the clinic group were more likely to experience a reduction in leg ulcer pain per month than control patients. Satisfaction was high in both groups, but there were no significant differences between the groups.²⁶

Economic evaluation
Complete data on resource use were available for 66% (214/323) of clinics and 62% (2110/3429) of recorded home visits. From these data, the mean (SD) cost per clinic attendance was estimated at £29.90 (£14.18), while the mean (SD) cost per home visit was estimated at £10.60 (£3.79).

	Discussion

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This subject is of economic importance, given the reported high annual cost to the health service for leg ulcer care. ^{6 28} Although it was impossible to separate the effect of four layer bandaging or of the specially trained nurses from the clinic setting, the present study pragmatically tested the "package" of care which was already being used elsewhere.

The age distribution of the patients recruited was similar to those reported elsewhere. ^{9 10 29 30} The baseline distributions of ulcer area and duration of ulcers, however, were much greater than those reported in other studies. ^{10 29 30} Within the context of other evidence on four layer bandaging the healing rate in the clinic group (34%) was lower than the rates reported as 74% and 69% in 12 weeks in dedicated clinics. ^{9 10} This probably reflects the larger areas and longer duration of ulcers at baseline in this trial. The nearest comparisons were described in two observational studies as 40% (of leg ulcers) in 12 weeks³¹ and 42% (of limbs) of people attending a leg ulcer clinic.³² The limitations for use of four layer bandaging in a community clinic include the fact that some people are unable to leave their home and cannot tolerate or do not like the treatment.³³ Patients have to accept the additional time they must spend travelling and waiting for and having treatment.

The outcomes of the SF-36 and EuroQol seemed to show an overall deterioration in health status in both groups and no improvement in the clinic group associated with the superior healing rate. This could be because the sample size was based on the expected difference in healing rates between the groups and not in health status scores. Other possible explanations are that the measures of health status were not sensitive enough to detect the changes in health specific to the condition or that the time points for follow up did not coincide with the time when the patients improved. The patients did have health problems apart from their leg ulcer and some even died during the trial. Possibly the impact of their leg ulcer was less than the impact of their other health conditions and the tools were accurately describing a deteriorating health status.

Economic evaluation
We undertook a modelling exercise to make the cost results more applicable to the real world. Clinic coordinators indicated that it was not necessary to use G or H grade nurses for the service. Reanalysis of the data with E grade salary costs gave a mean cost per clinic attendance of £27.61 and an annual NHS cost of around £740 per patient. The restrictions on throughput imposed by the trial produced an artificially high mean cost per attendance at the start and end of the trial. We estimated that by increasing throughput to more than 10 patients the mean cost per attendance could be reduced to £24.87 and the annual NHS costs to around £670 per patient. Altering both grade mix and throughput produced a mean cost per attendance of £23.37 and mean annual NHS costs of around £630 per patient (compared with £681 for traditional home treatment). With either scenario, the clinic treatment with four layer bandaging would dominate the home based treatments, being both cheaper and more clinically effective.