Management of Leg Ulcers The Role of the Gloucestershire Leg Ulcer Service Colin E. Davies MSc BSc(Hons) FAETC RGN Gloucestershire Leg Ulcer Service Cheltenham General Hospital

Introduction Common Low healing High recurrence Poor assessment Irrational treatment Chronic problem Expensive Historically, health professionals have found leg ulcers a less than exciting condition… Leg ulceration is a common, distressing problem, affecting approximately 1-2% of the UK population Traditionally, they have been difficult to manage, with associated poor healing rates, and… The likelihood of recurrence And in the past, little attempt was made to assess the underlying aetiology with subsequent treatment choices being influenced more by tradition and clever marketing than by credible research findings… The chronic symptoms such as pain, oedema, disfigurement and social isolation have a major impact on quality of life… And present a major expense to the health service

95% OF LEG ULCERS WILL BE VASCULAR Causes of Leg Ulcers Venous 70% Arterial 10% Arterial + venous 10-15% Non-vascular 5% Non-Vascular Co-Morbidities Malignancy Trauma Diabetes Rheumatoid Arthritis Vasculitis Blood disorders Metabolic disorders 95% OF LEG ULCERS WILL BE VASCULAR

Cause of Tissue Breakdown Carbon dioxide Oxygen Nutrients Carbon dioxide Waste metabolites Chronic Venous Hypertension Skin Capillary Waste metabolites Water Fibrinogen

Cause of Tissue Breakdown Fibrin cuff deposition White cell entrapment Growth factor entrapment Fibrin Leucocytes

Chronic Venous Hypertension Oedema Haemosiderin staining Atrophy blanche Ankle flare Lipodermatosclerosis Varicose veins Varicose eczema

Non-Vascular Causes Non-Vascular Co-Morbidities Malignancy 1 – 2% Trauma Diabetes Rheumatoid Arthritis Vasculitis Blood disorders Metabolic disorders

Assessment Ankle brachial pressure index Colour venous duplex ultrasound Arterial ultrasound scan

Refer to vascular surgeon Leg Ulcer Management ABPI 0.85-1.25 ABPI 0.5-0.85 Incompressible ABPI <0.5 Full compression Modified compression Refer to vascular surgeon Healed Deterioration Re-vascularisation

Evidence-Based Approach Compression Elevation Exercise X X X Optimum Healing Delayed Healing Compression + Elevation + Exercise =

Treatment Pathways However recurrence rates are high Venous Ulcers However recurrence rates are high Compression is lifelong Concordance is poor However, we are still challenged by the highly recurrent nature of chronic venous ulcers And compression therapy needs to be continued for life (or for as long as the venous disease is present) Unfortunately as we know, concordance with compression hosiery is often poor and haphazard.

ESCHAR Trial Ulcerated limb ABPI >0.85 Compression Compression + Surgery Monthly review 3 monthly review

Superficial Venous Reflux ESCHAR Results Superficial Venous Reflux 100 Surgery + compression 31% 12% 80 Compression alone Healed limbs % 60 40 20 p<0.0001 6 12 Months

Mixed superficial and segmental deep reflux ESCHAR Results Mixed superficial and segmental deep reflux 100 Surgery + compression 29% 9% 80 Compression Healed limbs % 60 40 p=0.04 20 12 6 Months

ESCHAR Results 41% refused surgery Lancet 2004 Jn 5; 363(9424): 1854-1859 41% refused surgery

Suitability for Further Intervention Superficial & total deep n = 500 15% Isolated superficial reflux 24% 61% Superficial & segmental deep reflux Barwell et al, 2004

The Leg Ulcer Service Established in 1995 Referral system Healing 24 Weeks Recurrence 12 Months P<0.01 Ghauri ASK, et al (1998) Eur J Endovasc Surg 16, 238-244 Established in 1995 Referral system One-stop assessment Nurse specialists Community clinics Vascular Unit link Management Protocol The leg ulcer service in Gloucestershire was established in 1995 as part of a regionally funded research study examining existing practices in leg ulcer management and evaluating the impact of dedicated vascular led clinics. There are a number of components which contribute to the success of our service… Our easy-access referral system – we accept referrals from GP’s, practice and community nurses, hospital wards and departments, and self referrals from patients… Patients are invited to attend for a one-stop vascular assessment in the vascular lab where they receive hand-held Doppler assessment of arteries and colour venous duplex scanning of leg veins as standard. Patients are then seen by one of the specialist nurses and treatment pathways commenced. Following this they are regularly seen in one of our countywide community based follow-up clinics for review. One of the fundamental components is the direct link our service offers between patients / primary care teams and the specialist nurses, vascular laboratory and vascular surgeons. We have developed clearly defined evidence-based management protocols in collaboration with our consultant colleagues. One of the fundamental components is the direct link our service offers between the patient / primary care teams and the specialist nurses, vascular laboratory and vascular surgeons. We have established clearly defined protocols in collaboration with the vascular consultants.

The Leg Ulcer Service Established in 1995 Referral system One-stop assessment Nurse specialists Community clinics Vascular Unit link Management Protocol The leg ulcer service in Gloucestershire was established in 1995 as part of a regionally funded research study examining existing practices in leg ulcer management and evaluating the impact of dedicated vascular led clinics. There are a number of components which contribute to the success of our service… Our easy-access referral system – we accept referrals from GP’s, practice and community nurses, hospital wards and departments, and self referrals from patients… Patients are invited to attend for a one-stop vascular assessment in the vascular lab where they receive hand-held Doppler assessment of arteries and colour venous duplex scanning of leg veins as standard. Patients are then seen by one of the specialist nurses and treatment pathways commenced. Following this they are regularly seen in one of our countywide community based follow-up clinics for review. One of the fundamental components is the direct link our service offers between patients / primary care teams and the specialist nurses, vascular laboratory and vascular surgeons. We have developed clearly defined evidence-based management protocols in collaboration with our consultant colleagues. One of the fundamental components is the direct link our service offers between the patient / primary care teams and the specialist nurses, vascular laboratory and vascular surgeons. We have established clearly defined protocols in collaboration with the vascular consultants. General Practitioners Leg Ulcer Service Community Nurses Dermatologists Patient Self-Referral Ward Nurses Other Specialists Practice Nurses 18

The Leg Ulcer Service Established in 1995 Referral system One-stop assessment Nurse specialists Community clinics Vascular Unit link Management Protocol The leg ulcer service in Gloucestershire was established in 1995 as part of a regionally funded research study examining existing practices in leg ulcer management and evaluating the impact of dedicated vascular led clinics. There are a number of components which contribute to the success of our service… Our easy-access referral system – we accept referrals from GP’s, practice and community nurses, hospital wards and departments, and self referrals from patients… Patients are invited to attend for a one-stop vascular assessment in the vascular lab where they receive hand-held Doppler assessment of arteries and colour venous duplex scanning of leg veins as standard. Patients are then seen by one of the specialist nurses and treatment pathways commenced. Following this they are regularly seen in one of our countywide community based follow-up clinics for review. One of the fundamental components is the direct link our service offers between patients / primary care teams and the specialist nurses, vascular laboratory and vascular surgeons. We have developed clearly defined evidence-based management protocols in collaboration with our consultant colleagues. One of the fundamental components is the direct link our service offers between the patient / primary care teams and the specialist nurses, vascular laboratory and vascular surgeons. We have established clearly defined protocols in collaboration with the vascular consultants. 19

The Leg Ulcer Service Established in 1995 Referral system One-stop assessment Nurse specialists Community clinics Vascular Unit link Management Protocol The leg ulcer service in Gloucestershire was established in 1995 as part of a regionally funded research study examining existing practices in leg ulcer management and evaluating the impact of dedicated vascular led clinics. There are a number of components which contribute to the success of our service… Our easy-access referral system – we accept referrals from GP’s, practice and community nurses, hospital wards and departments, and self referrals from patients… Patients are invited to attend for a one-stop vascular assessment in the vascular lab where they receive hand-held Doppler assessment of arteries and colour venous duplex scanning of leg veins as standard. Patients are then seen by one of the specialist nurses and treatment pathways commenced. Following this they are regularly seen in one of our countywide community based follow-up clinics for review. One of the fundamental components is the direct link our service offers between patients / primary care teams and the specialist nurses, vascular laboratory and vascular surgeons. We have developed clearly defined evidence-based management protocols in collaboration with our consultant colleagues. One of the fundamental components is the direct link our service offers between the patient / primary care teams and the specialist nurses, vascular laboratory and vascular surgeons. We have established clearly defined protocols in collaboration with the vascular consultants. 20

The Leg Ulcer Service Established in 1995 Referral system One-stop assessment Nurse specialists Community clinics Vascular Unit link Management Protocol GLOUCESTER Cinderford CHELTENHAM Bourton-on-the-Water Cirencester Tewkesbury Stroud Moreton-in –the-Marsh The leg ulcer service in Gloucestershire was established in 1995 as part of a regionally funded research study examining existing practices in leg ulcer management and evaluating the impact of dedicated vascular led clinics. There are a number of components which contribute to the success of our service… Our easy-access referral system – we accept referrals from GP’s, practice and community nurses, hospital wards and departments, and self referrals from patients… Patients are invited to attend for a one-stop vascular assessment in the vascular lab where they receive hand-held Doppler assessment of arteries and colour venous duplex scanning of leg veins as standard. Patients are then seen by one of the specialist nurses and treatment pathways commenced. Following this they are regularly seen in one of our countywide community based follow-up clinics for review. One of the fundamental components is the direct link our service offers between patients / primary care teams and the specialist nurses, vascular laboratory and vascular surgeons. We have developed clearly defined evidence-based management protocols in collaboration with our consultant colleagues. One of the fundamental components is the direct link our service offers between the patient / primary care teams and the specialist nurses, vascular laboratory and vascular surgeons. We have established clearly defined protocols in collaboration with the vascular consultants. 21

Community Leg Ulcer Clinics The Leg Ulcer Service Established in 1995 Referral system One-stop assessment Nurse specialists Community clinics Vascular Unit link Management Protocol The leg ulcer service in Gloucestershire was established in 1995 as part of a regionally funded research study examining existing practices in leg ulcer management and evaluating the impact of dedicated vascular led clinics. There are a number of components which contribute to the success of our service… Our easy-access referral system – we accept referrals from GP’s, practice and community nurses, hospital wards and departments, and self referrals from patients… Patients are invited to attend for a one-stop vascular assessment in the vascular lab where they receive hand-held Doppler assessment of arteries and colour venous duplex scanning of leg veins as standard. Patients are then seen by one of the specialist nurses and treatment pathways commenced. Following this they are regularly seen in one of our countywide community based follow-up clinics for review. One of the fundamental components is the direct link our service offers between patients / primary care teams and the specialist nurses, vascular laboratory and vascular surgeons. We have developed clearly defined evidence-based management protocols in collaboration with our consultant colleagues. One of the fundamental components is the direct link our service offers between the patient / primary care teams and the specialist nurses, vascular laboratory and vascular surgeons. We have established clearly defined protocols in collaboration with the vascular consultants. Hospital Community Leg Ulcer Clinics Home Specialist Nurses Vascular Lab Primary Care Teams Vascular Surgeon 22

The Leg Ulcer Service Established in 1995 Referral system One-stop assessment Nurse specialists Community clinics Vascular Unit link Management Protocol The leg ulcer service in Gloucestershire was established in 1995 as part of a regionally funded research study examining existing practices in leg ulcer management and evaluating the impact of dedicated vascular led clinics. There are a number of components which contribute to the success of our service… Our easy-access referral system – we accept referrals from GP’s, practice and community nurses, hospital wards and departments, and self referrals from patients… Patients are invited to attend for a one-stop vascular assessment in the vascular lab where they receive hand-held Doppler assessment of arteries and colour venous duplex scanning of leg veins as standard. Patients are then seen by one of the specialist nurses and treatment pathways commenced. Following this they are regularly seen in one of our countywide community based follow-up clinics for review. One of the fundamental components is the direct link our service offers between patients / primary care teams and the specialist nurses, vascular laboratory and vascular surgeons. We have developed clearly defined evidence-based management protocols in collaboration with our consultant colleagues. One of the fundamental components is the direct link our service offers between the patient / primary care teams and the specialist nurses, vascular laboratory and vascular surgeons. We have established clearly defined protocols in collaboration with the vascular consultants. 23

Management Strategies One-Stop Assessment Clinic Multilayer Compression + Hosiery Biopsy Pinch Skin Grafting RCT Superficial Venous Surgery ESCHAR Foam Larvae Therapy RCT Well Leg Clinic 1995 2000 2005 2012

Improvement in Outcomes All data were collected from a prospective database Covering all patients referred to the service from November 1995 – the end of December 2010 This cohort of patients were referred into the leg ulcer service mainly from primary care nurses, but also from GPs and from patients themselves and also from other hospital departments and wards. Prospective database November 1995 – December 2010 Healing Recurrence

Improvement in Outcomes 7481 legs on database Excluded (n=2085) ¨  Arterial, malignant, diabetic, rheumatoid, others ¨  Lost to follow up 5396 legs Data analysed prospectively for: ¨ 24 week healing rates 12 month recurrence rates 7481 legs were recorded on a prospective database from November 1995 – the end of December 2010 Of these, 2085 legs were excluded either because they had arterial ulcers or the patient was lost to follow up. Therefore for the purpose of this study, 5396 legs were included. Data was analysed prospectively for 24 week healing rates and 12 month recurrence… And retrospectively for workload and referral rates.

24 Week Healing Healed (%) Weeks 29 % We have seen a consistent improvement in healing rates at 24 weeks. This can be clearly seen in these Kaplan-Meier curves based on life table analysis. The graph has been split into 4 groups of years covering the period 1995 – 2010 The lower curve represents the period 1995 – 1998 in which 24 week healing rates were 63% Whereas the uppermost (maroon) curve covering the years 2007 – 2010 show 24 week healing rates to be 81% 100 --- 2007 – 2010 --- 2003 – 2006 --- 1999 – 2002 --- 1995 – 1998 81% 80 29 % 63% 60 Healed (%) 40 20 10 20 30 40 Weeks

12 Month Recurrence Recurrence (%) Weeks 33% Similarly, recurrence rates have seen a consistent improvement. Again the graph shows four KM curves covering 1995 – 2010 Recurrence rates at 1 year were 20.1% for the period 1995 – 1998 and indeed increased slightly in the following 4 years However for 2007 – 2010 the 12 month recurrence rate was 13.5% 13.5% 33% --- 2007 – 2010 --- 2003 – 2006 --- 1999 – 2002 --- 1995 – 1998 20 20.1% 40 Recurrence (%) 60 80 100 10 20 30 40 50 60 Weeks

Conclusions 29% 63% 81% Improved healing 179% 24 healed at 24 weeks So in conclusion… A dedicated specialist leg ulcer service remains the gold standard for patients with chronic leg ulceration. Our service here in Gloucestershire continues to have a positive impact on outcomes by: Improving healing rates, and Reducing recurrence. However, the model developed here in Gloucestershire is not universally adopted as standard. There is still much disparity in leg ulcer management throughout the UK despite the availability of evidence-based guidelines; and there is a great need for a national consensus on best practice. We would welcome the establishment of a nationally agreed protocol for management (or national service framework), setting clear quality requirements for care, based on the best available evidence of what treatments and services work most effectively for patients. THANK YOU Improved healing Before Service 29% healed at 24 weeks Audit 1995 - 1998 63% healed at 24 weeks 2007 - 2010 81% healed at 24 weeks Prospective 179%

Conclusions 54% 20.1% 13.5% Reduced recurrence - 75% Before Service recurrence at 12 months Audit 1995 - 1998 20.1% recurrence at 12 months 2007 - 2010 13.5% recurrence at 12 months Prospective - 75%

Conclusions Leg ulcer management benefits from… Secondary care assessment Specialist vascular-led clinics Clearly defined, evidence-based protocols Further intervention And that leg ulcer management clearly benefits from Secondary care assessment Specialist leg ulcer clinics providing regular follow-up and easy access to vascular surgeons and further investigations Care shared with primary care teams allowing access to training and development Clearly defined, evidence-based protocols Further intervention to reduce the risk of recurrence and increase ulcer-free time for patients Continued research into the pathophysiology of leg ulceration

Thank you colin.davies@glos.nhs.uk www.cheltenhamvascularunit.co.uk