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Background: Treatment of superficial venous reflux in addition to compression therapy accelerates venous leg ulcer healing and reduces ulcer recurrence. The aim of this study was to evaluate the costs and cost-effectiveness of early versus delayed endovenous treatment of patients with venous leg ulcers., Methods: This was a within-trial cost-utility analysis with a 1-year time horizon using data from the EVRA (Early Venous Reflux Ablation) trial. The study compared early versus deferred endovenous ablation for superficial venous truncal reflux in patients with a venous leg ulcer. The outcome measure was the cost per quality-adjusted life-year (QALY) over 1 year. Sensitivity analyses were conducted with alternative methods of handling missing data, alternative preference weights for health-related quality of life, and per protocol., Results: After early intervention, the mean(s.e.m.) cost was higher (difference in cost per patient £163(318) (€184(358))) and early intervention was associated with more QALYs at 1 year (mean(s.e.m.) difference 0·041(0·017)). The incremental cost-effectiveness ratio (ICER) was £3976 (€4482) per QALY. There was an 89 per cent probability that early venous intervention is cost-effective at a threshold of £20 000 (€22 546)/QALY. Sensitivity analyses produced similar results, confirming that early treatment of superficial reflux is highly likely to be cost-effective., Conclusion: Early treatment of superficial reflux is highly likely to be cost-effective in patients with venous leg ulcers over 1 year. Registration number: ISRCTN02335796 (http://www.isrctn.com)., (© 2019 BJS Society Ltd Published by John Wiley & Sons Ltd.)

Background: The aim was to assess healing in patients with mixed arterial and venous leg ulcers after protocol-driven treatment in a specialist leg ulcer clinic., Methods: The study included consecutive patients referred with leg ulceration and venous reflux over 6 years. Legs without arterial disease (ankle : brachial pressure index (ABPI) above 0.85) were treated with multilayer compression bandaging and patients with severe disease (ABPI 0.5 or less) were considered for immediate revascularization. Those with moderate arterial compromise (ABPI above 0.5 up to 0.85) were initially managed with supervised modified compression and considered for revascularization if their ulcer did not heal. Healing rates were determined using life-table analysis., Results: Of 2011 ulcerated legs, 1416 (70.4 per cent) had venous reflux. Of these 1416, 193 (13.6 per cent) had moderate and 31 (2.2 per cent) had severe arterial disease. Healing rates by 36 weeks were 87, 68 and 53 per cent for legs with insignificant, moderate and severe arterial disease respectively (P < 0.001). Seventeen legs with moderate and 15 with severe arterial disease were revascularized. Of these, ulcers healed in four legs with moderate and seven with severe disease within 36 weeks of revascularization (P = 0.270). Combined 30-day mortality for revascularization was 6.5 per cent., Conclusion: A protocol including supervised modified compression and selective revascularization achieved good healing rates for mixed arterial and venous leg ulceration., (Copyright (c) 2007 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.)

Background: The aim of this study was to evaluate the anatomical and haemodynamic effects of superficial venous surgery and compression on legs with chronic venous ulceration., Methods: Legs with open or recently healed ulceration and saphenous reflux were treated with multilayer compression bandaging or superficial venous surgery plus compression as part of a clinical trial. Venous duplex imaging was performed before treatment and at 1 year. Legs were stratified before surgery as having no deep reflux, segmental deep reflux or total deep reflux. Venous refill times (VRTs) were calculated before treatment and at 1 year using photoplethysmography, with and without a narrow below-knee cuff inflated to 80 mmHg., Results: Of 214 legs investigated, 112 were treated with compression and 102 with compression plus surgery. Saphenous surgery abolished deep reflux in ten of 22 legs with segmental deep reflux and three of 17 with total deep reflux. Overall median (range) VRT increased from 10 (3-48) to 15 (4-48) s 1 year after surgery (P < 0.001). Preoperative change in VRT on application of a below-knee tourniquet correlated with actual change in VRT following surgery., Conclusion: Superficial venous surgery resulted in a significant haemodynamic benefit for legs with venous ulceration despite co-existent deep reflux; residual saphenous reflux was common., (Copyright (c) 2005 British Journal of Surgery Society Ltd.)

Background: The aim of this study was to compare the cost-effectiveness of four-layer compression bandaging for venous leg ulcers with that of other available treatments., Methods: In this pragmatic trial, 200 patients with a venous leg ulcer were randomized either to four-layer bandaging (intervention group; n = 100) or to continue their usual system of care (control group; n = 100). The follow-up for each patient was 12 weeks. Analysis was by intention to treat; the main outcome measures were time to healing and cost to the health board per leg healed., Results: Baseline characteristics were well matched in the two groups. The Kaplan-Meier estimate of the healing rate at 3 months was 54 per cent with four-layer bandaging and 34 per cent in the control group. Throughout the 3 months, four-layer bandaging healed leg ulcers significantly earlier (P = 0.006). There was a significant reduction in the median cost per leg healed with four-layer bandaging (euro 210 versus euro 234; P = 0.040)., Conclusion: Four-layer bandaging is currently the most effective method of treating venous leg ulcers in a community setting., (Copyright 2003 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.)

Background: The aim of this study was to determine the ability of superficial venous surgery to heal venous ulcers in lower legs with isolated superficial venous incompetence., Methods: This was a prospective study of patients recruited from a venous ulcer assessment clinic. Ulcers were considered venous if the ankle : brachial pressure index was greater than 0.8 and duplex imaging showed venous reflux. Patients with isolated superficial venous incompetence were offered saphenofemoral and/or saphenopopliteal surgery. Neither perforator surgery, skin grafting nor postoperative compression hosiery or bandaging was used., Results: A total of 122 legs with normal deep veins underwent superficial venous surgery. Ninety procedures (74 per cent) were done under local and 32 (26 per cent) under general anaesthesia. Sixty operations (49 per cent) were done as a day case. The median time to healing was 18 (95 per cent confidence interval 14-21) weeks and the cumulative 6-, 12- and 18-month healing rates were 57, 74 and 82 per cent respectively., Conclusion: In patients with venous ulceration and isolated superficial venous incompetence, superficial venous surgery can produce ulcer healing in the majority of patients without the need for perforator surgery, postoperative compression bandaging or skin grafting.

Background: Musculoskeletal dysfunction may be associated with poor calf muscle pump function in patients with chronic venous ulceration. The aim of this study was to evaluate the effects of physical exercise on calf muscle pump function., Methods: Twenty patients were recruited into a 6-week intensive exercise programme. Calf muscle function and calf muscle pump function were assessed using an isokinetic device and air plethysmography respectively, before and after the exercise programme., Results: There was significant improvement in calf muscle pump function, measured as increased ejection fraction and decreased residual fraction (P < 0.05); however, venous reflux was not altered (P > 0.05). Calf muscle strength and endurance parameters all increased, but not significantly (P > 0.05)., Conclusion: Poor calf muscle pump function in patients with chronic venous ulceration can be improved by physical exercise.

Background: This paper describes local anaesthetic saphenous disconnection in elderly patients for the treatment of venous ulceration in legs with either saphenous venous reflux alone or in combination with deep venous reflux., Methods: Ambulatory venous pressure was measured in 16 legs with saphenous vein reflux alone and in nine legs with combined deep and saphenous venous reflux before, immediately after and 3 months after saphenofemoral or popliteal disconnection. Ulcer area was measured by computerized planimetry before surgery and at 1 and 3 months after operation. No compression bandages or hose were applied after surgery unless the ulcers had not begun to heal after 1 month., Results: In legs with saphenous reflux alone all ulcers healed without compression bandages at a median of 81 (range 14-253) days and the pressure relief index (PRI) improved significantly both after surgery and at follow-up. None of the ulcers in the nine limbs with saphenous and deep venous reflux healed without compression bandaging and the PRI was unchanged immediately following surgery and at follow-up., Conclusion: Saphenous vein disconnection improves venous function and heals venous ulcers without compression bandaging if the deep veins are normal. This procedure under local anaesthetic may be particularly suitable for elderly patients, but long saphenous vein stripping should be added in young patients.

Background: The relationship between deep and superficial venous reflux and healing of venous ulceration by non-operative compression therapy has not been studied previously., Methods: A total of 155 patients with chronic venous ulcers underwent duplex ultrasonography before treatment with compression bandaging at a hospital-based venous clinic., Results: At 24 weeks, 104 (67 per cent) of ulcers had healed. There was no significant difference in the pattern of either deep or superficial venous reflux between healed and non-healed ulcers except with respect to the popliteal vein. In healed ulcers, 39 scans (38 per cent) indicated competence of the above-knee popliteal vein compared with five (10 per cent) in the non-healing group (P < 0.001, chi 2 test). Similarly, 43 scans (42 per cent) showed below-knee popliteal vein competence in the healed ulcers compared with only five (10 per cent) performed in legs remaining ulcerated (P < 0.001, chi 2 test)., Conclusion: Popliteal vein incompetence is an indicator of poor response to compression therapy for venous ulceration.

The interstitial fibrinolytic activity of the upper and lower limbs was investigated in subjects with abnormal calf pump function by measuring the lysis rate of experimentally produced subcutaneous 125I-fibrin clots. Thirty-three subjects with healed venous ulcers, five with varicose veins and 11 controls were studied. 125I-fibrin clots were produced in the subcutaneous tissue of the forearms and legs and clearance half-life was calculated. Calf pump function was assessed by foot volumetry and the 'gaiter' skin nutritive circulation by measuring the transcutaneous oxygen tension (PtcO2). Fibrin clearance was prolonged from the subcutaneous tissues of the legs of subjects with varicose veins and healed ulcers compared with controls. Negative correlations were found between fibrin clearance half-life and the half-volume refilling time (P less than 0.01) and the PtcO2 (P less than 0.01).

We examined the levels of oxygen on the skin of the gaiter areas of limbs with venous disease using a Roche Transcutaneous pO2 Monitor to determine whether hypoxia contributes to the skin changes and ulceration associated with severe venous disease. We studied patients with superficial varicose veins and no skin changes (Group 1: n = 25), patients with skin changes and healed ulcers (Group 2: n = 15), and an age matched normal control group (controls: n = 25). TcpO2 measurements were taken 5 cm above the medial malleolus with the limb both horizontal and vertical using a Roche Transcutaneous pO2 Monitor. A standard heel-raising test using a Medisonics Photoplethysmograph indicated the degree of venous insufficiency present. Results show that Group 1 patients and controls have similar skin oxygen levels (Group 1: TcpO2 66.48 + 14.12 mmHg; controls: TcpO2 61.60 +/- 11.02 mmHg) whereas those with skin changes and ulceration have significantly lower oxygen levels (Group 2: TcpO2 46.57 +/- 9.70 mmHg, t = 4.29, P less than 0.001). Group 2 patients did not show a significant rise in TcpO2 levels in the standing position whereas Group 1 patients and controls did (t = 2.6, P less than 0.02). PPG post-exercise recovery times confirmed differences between the three groups. These findings show that significant skin hypoxia occurs on the gaiter area of limbs with severe venous disease and support the concept of an oxygen diffusion block.

This study of 51 patients aims to define the 'normal' range of reflux in the deep veins and the incidence of pathological reflux in patients with the post-thrombotic syndrome (PTS). 'Normal' limbs, limbs with simple varicose veins and limbs with post-thrombotic syndrome have been studied using a standardized technique for descending phlebography, supine and with a controlled Valsalva. The 'normal' range of reflux has been found to be grade 0-2. The incidence of pathological reflux in patients with proven post-thrombotic damage to the deep veins is 31 per cent.

The changes in foot vein pressure during exercise have been measured in 30 normal legs and 109 legs with varicose veins or postphlebitic changes and correlated with the number of capillaries visible in a histological section of skin from the ulcer-bearing area. There was a significant correlation between the inability of the calf pump to reduce foot vein pressure during exercise and the number of capillaries in the skin. It is suggested that the increased number of capillaries secondary to venous hypertension during exercise may be the prime cause of the nutritional abnormalities that eventually cause a venous ulcer.

Calf muscle pump function was assessed in 41 limbs after venous ulcers had healed. Treatment was then randomized either to ligation of incompetent lower leg communicating veins and ablation of incompetent superficial veins combined with permanent graduated compression elastic stockings, or to graduated compression elastic stockings only. Half volume refilling time (TV1/2) and relative expelled volume (EVrel) measured on foot volume plethysmography were used to assess calf muscle pump function. This was repeated after 12 months. The initial TV1/2 and EVrel were significantly lower than for normal limbs. There was no significant improvement in TV1/2 in either treatment group (Student's t test, P = 0.78, P = 0.19). EVrel did not improve significantly in limbs treated with elastic stockings alone (P = 0.94), but there was a slight but significant improvement in EVrel in limbs treated with surgery and elastic stockings (P = 0.048); however, this was still significantly below the normal range (P less than 0.001). In limbs without phlebographic evidence of post-thrombotic changes, treated with the combination of surgery and elastic stockings, there was a significant improvement in EVrel (P = 0.035), but no improvement was found in limbs with post-thrombotic changes. This small but significant improvement in EVrel in limbs without post-thrombotic changes treated by surgery and elastic stockings may explain the reduced incidence of reulceration that has been found following surgical eradication of the superficial and communicating veins.