Compression therapy for venous leg ulcers: risk factors for adverse events and complications, contraindications - a review of present guidelines.

INTRODUCTION: The adequate use of compression in venous leg ulcer treatment is equally important to patients as well as clinicians. Currently, there is a lack of clarity on contraindications, risk factors, adverse events and complications, when applying compression therapy for venous leg ulcer patients. METHODS: The project aimed to optimize prevention, treatment and maintenance approaches by recognizing contraindications, risk factors, adverse events and complications, when applying compression therapy for venous leg ulcer patients. A literature review was conducted of current guidelines on venous leg ulcer prevention, management and maintenance. RESULTS: Searches took place from 29th February 2016 to 30th April 2016 and were prospectively limited to publications in the English and German languages and publication dates were between January 2009 and April 2016. Twenty Guidelines, clinical pathways and consensus papers on compression therapy for venous leg ulcer treatment and for venous disease, were included. Guidelines agreed on the following absolute contraindications: Arterial occlusive disease, heart failure and ankle brachial pressure index (ABPI) <0.5, but gave conflicting recommendations on relative contraindications, risks and adverse events. Moreover definitions were unclear and not consistent. CONCLUSIONS: Evidence-based guidance is needed to inform clinicians on risk factor, adverse effects, complications and contraindications. ABPI values need to be specified and details should be given on the type of compression that is safe to use. Ongoing research challenges the present recommendations, shifting some contraindications into a list of potential indications. Complications of compression can be prevented when adequate assessment is performed and clinicians are skilled in applying compression.

The Static Stiffness Index: an important parameter to characterise compression therapy in vivo.

The compression pressure, which corresponds to the dosage of compression therapy, has been widely neglected up to now, not only concerning scientific literature, but also in clinical practice. It is evident that compression pressures in the upright position and during walking are clinically more relevant than just the resting pressure. The Static Stiffness Index (SSI), which is the difference between standing and resting pressure, is a valuable parameter characterising the efficacy of a specific compression product to narrow/occlude the venous lumen. This is a prerequisite for reducing venous reflux and exerting a massaging effect necessary to improve the venous pumping function during movement. This article provides an overview of the recent literature on the SSI, which supports the recommendations of the International Compression Club. In addition, it aims to provide an insight on the importance of the SSI in daily practice, as an educational tool as well as in defining the properties of applied compression therapy in clinical research.

Recalcitrant Venous Leg Ulcers May Heal by Outpatient Treatment of Venous Disease Even in the Presence of Concomitant Arterial Occlusive Disease.

OBJECTIVE/BACKGROUND: Peripheral arterial occlusive disease (PAOD) is reported in about 15-20% of patients with venous leg ulcers (VLU). In such cases arterial recanalization is often recommended, and compression therapy is considered a contraindication when the ankle brachial pressure index (ABPI) is < 0.8. The aim of this study was to compare the outcome of patients with recalcitrant VLU, both without any arterial impairment ("pure venous recalcitrant leg ulcer" [pvRLU]) and with associated PAOD ("mixed arterial and venous recalcitrant leg ulcer" [mavRLU]), by treating only the venous disease. METHODS: The records of 180 outpatients with recalcitrant ulcers treated between January 2011 and July 2014 were reviewed retrospectively. In total, 109 were affected by pvRLU and 71 by mavRLU, with moderate PAOD defined by an ABPI between 0.5 and 0.8. In addition to the same local wound dressing, the patients received ultrasound guided foam sclerotherapy of the refluxing superficial veins and a modified inelastic compression with a pressure ≤ 40 mmHg. No patient was referred for arterial revascularization. The patients were followed until ulcer healing. RESULTS: Patients with pvRLU and mavRLU showed comparable demographic characteristics. Twenty-five patients were lost to follow up and the outcomes were analyzed in 93 patients with pVLU (85.4%) and in 62 patients with mavRLU (87.4%). The maximum time to complete healing was 48 weeks in the pvRLU group and 52 weeks in the mavRLU group (p = .009), The median healing time was 23 (pvRLU) versus 25.5 weeks (mavRLU) (p = .030). Deep venous incompetence (p < .001), ulcer surface area (p < .001), arterial disease (p = .002), and ulcer duration (p < .010) were risk factors for prolonged healing. CONCLUSION: Treatment of recalcitrant leg ulcers by treating venous incompetence by foam sclerotherapy and modified compression is successful, even if underlying moderate PAOD is not actively treated.

Adjustable Velcro Compression Devices are More Effective than Inelastic Bandages in Reducing Venous Edema in the Initial Treatment Phase: A Randomized Controlled Trial.

OBJECTIVE/BACKGROUND: The objective of this study was to compare the efficacy and comfort of inelastic bandages (IBs) and adjustable Velcro compression devices (AVCDs) in reducing venous leg edema in the initial treatment phase. METHODS: Forty legs from 36 patients with untreated venous edema (C3EpsAsdPr) were randomized to two groups. Patients in the first group received IBs (n = 20) and those in the second AVCDs (n = 20). Both compression devices were left on the leg day and night, and were renewed after 1 day. Patients in the AVCD group were asked to re-adjust the device as needed when it felt loose. Leg volume was calculated using the truncated cone formula at baseline (T0), after 1 day (T1) and after 7 days (T7). The interface pressure of the two compression devices was measured by an air filled probe, and the static stiffness index calculated after applying compression at T0 and T1, and just before removal of compression on T1 and T7. Patient comfort with regard to the two compression systems was assessed by grading signs and symptoms using a visual analog scale. RESULTS: At T1, the median percent volume reduction was 13% for the IB group versus 19% for the AVCD group; at T7 it was 19% versus 26%, respectively (p < .001). The pressure of the IBs was significantly higher compared with the AVCDs at T0 (63 vs. 43 mmHg) but dropped by > 50% over time, while it remained unchanged with AVCDs owing to the periodic readjustment by the patient. Comfort was reported to be similar with the two compression devices. CONCLUSION: Re-adjustable AVCDs with a resting pressure of around 40 mmHg are more effective in reducing chronic venous edema than IBs with a resting pressure of around 60 mmHg. AVCDs are effective and well tolerated, not only during maintenance therapy, but also in the initial decongestive treatment phase of patients with venous leg edema.

Comparative study of two antimicrobial dressings in infected leg ulcers: a pilot study.

OBJECTIVE: The aim of the study was to compare the efficacy of a microorganism-binding (MB) dressing with a silver-containing hydrofiber (SCH) dressing in controlling the bacterial loads of heavily colonised or locally infected chronic venous leg ulcers, before surgical management with homologous skin grafts. METHOD: A randomised comparative single centre study recruited patients presenting with hard-to-heal critically colonised or locally infected leg ulcers, who could be treated with skin grafting. Inclusion criteria included; ulcers of vascular aetiology, over 18 years old, a wound duration ≥6 months and ankle brachial index (ABPI) >0.6. Patients were randomly assigned to treatment with SCH dressings (Aquacel Ag) or MB dressing (Cutimed Sorbact). Dressings were changed daily over a four-day observation period, after which they were taken for a skin grafting procedure. Swab samples from ulcer beds were taken in order to quantify the bacterial load at inclusion (D0) and at the end of the observation period day 4 (D4). No antibiotics were administered before or during the evaluation period. RESULTS: Both groups (n=20 SCH, n=20 MB) were similar in gender, age, pathophysiology (both had 15 patients with venous leg ulcers and 5 with arterial leg ulcers), ulcer surface, ulcer duration, treatment-related pain and initial bacterial load. Analysing bacterial load variation showed a significant reduction of bacterial burden at D4 in both groups. In the SCH group, we found an average bacterial load reduction of 41.6%, with an average reduction of 73.1% in the MB group (p< 0.00001). No serious adverse events were reported. CONCLUSION: Our evaluation confirmed that MB and SCH dressings are effective in reducing the bacterial burden in critically colonised or locally infected chronic leg ulcers, without inducing adverse events, with MB dressings significantly more effective. DECLARATION OF INTEREST: There were no external sources of funding for this study. The authors have no conflicts of interest to declare.

Sport socks do not enhance calf muscle pump function but inelastic wraps do.

AIM: Aim of the study was to measure the effect of elastic and inelastic compression on calf muscle pump function in healthy male athletes. METHODS: This was an experimental study which included 21 healthy male athletes. The ejection fraction (EF) of the venous calf pump was measured comparing the effects of a variety of compression materials: 1) sport compression stockings; 2) light zinc paste bandages; 3) sport compression stockings with additional Velcro® wraps over the calf. The influence of sport stocking and wraps on the venous calibre at the largest calf circumference in the lying and standing position was investigated using MRI. RESULTS: Inelastic compression exerting a median pressure in the standing position of 37.5 mmHg (zinc paste) and 48 mmHg (loosely applied straps over a sport stocking) achieved a significant increase of EF up to 100%. Sport stockings alone with a standing pressure of 19-24 mmHg did not show a significant change of EF. MRI demonstrated some venous narrowing in the lying but not in the standing position. By wrapping inelastic straps over the stocking an emptying of the veins in the lying and a considerable narrowing in the standing position could be observed. CONCLUSION: Venous calf pump function in athletes is not influenced by elastic sport stockings, but inelastic wraps either alone or applied over sport stockings lead to a significant enhancement.

Improvement of venous pumping function by double progressive compression stockings: higher pressure over the calf is more important than a graduated pressure profile.

BACKGROUND: Previous studies have shown that so-called progressive elastic compression stockings (PECS) with a negative pressure gradient have a more pronounced effect on venous pump function than conventional, graduated stockings. The aim of this study was to investigate the effect of higher graduated and non-graduated pressures on the venous calf pump in patients with venous disease. METHODS: The ejection fraction (EF) of the calf pump was measured by plethysmography under a standardized walking test in 20 patients suffering from chronic venous disease (CEAP C2-C5) without compression, (a) with one and (b) two PECS on top of each other, and (c) with one additional conventional stocking covering only the gaiter area to achieve a graduated high pressure profile. Interface pressure was measured in the gaiter area and on the calf. RESULTS: A significant improvement of EF compared with baseline was found with all three compression modalities. The two superimposed PECS, providing median pressures of 33 mmHg in the gaiter area and 46 mmHg at calf level, increased EF significantly up into the normal range. Increasing the gaiter pressure to 56 mmHg without changing the calf pressure did not result in further improvement. CONCLUSIONS: Two PECS applied on top of each other lead to a maximal improvement of the venous pump function, which cannot be further improved by increasing the pressure in the gaiter area thereby restoring a graduated pressure profile.

Bandages or double stockings for the initial therapy of venous oedema? A randomized, controlled pilot study.

OBJECTIVE/BACKGROUND: Treatment for leg oedema conventionally starts with compression bandaging followed by elastic stockings once swelling is reduced. The aim was to investigate if a kit consisting of a liner and outer stocking, each exerting 20 mmHg of pressure, would be equally effective in achieving and maintaining volume reduction compared with short-stretch bandaging (2 weeks) followed by a class II (23-33 mmHg) stocking (2 weeks). METHODS: Forty legs (28 patients) with chronic venous oedema were randomised to either short-stretch bandages applied weekly for 2 weeks, followed by an elastic stocking for 2 weeks (group A) or a light stocking ("liner") for 1 week followed by superimposing a second stocking for 3 weeks (group B). Interface pressures and leg volumes were measured weekly. RESULTS: Despite differences in the pressure (median ± interquartile range) applied (bandage: 67 mmHg [55.7-73.0] vs. liner 24.5 mmHg [21.2-26.5]) volume reduction after 1 week was equal (12.8% [8.7-16.5] and 13.0% [10.4-20.6]). After 2 weeks (group A: 17.8% [10.6-20.0] vs. group B 16.2% [13.0-25.4]) and 4 weeks (group A: 17.3% [9.6-22.8] vs. group B: 17.0% [13.1-24.1]) volume reductions remained identical. CONCLUSIONS: The initial improvement in leg volume (1 week) was independent of the pressure applied and the reduction was maintained by superimposing a second stocking. This offers a simple alternative for managing leg oedema with reduced staffing costs.

Post-treatment compression: duration and techniques.

BACKGROUND: Compression treatments used the following intervention for varicose veins range from no compression, to elastic stockings and compression bandaging. There is no consensus on the strength or duration of compression which should be applied following a particular treatment. The author reviews the evidence that has led him to reach his own viewpoint on this subject. SUMMARY: Compression stockings are often prescribed after treatment of varicose veins, but these in general exert a much lower pressure in the thigh compared with firm inelastic compression bandages. It has been shown by objective investigation that it takes a pressure of 10-15 mmHg in the supine position and 40-50 mmHg in the standing position to occlude a superficial vein in the thigh. The author has published a study in which three groups of patients were studied following varicose vein surgery. One group received a strong medical compression stocking, the second group an inelastic bandaging system which achieved 63 mmHg compression in the standing position and an eccentric compression system which achieved 98 mmHg in the standing position. Adverse events after surgery were most frequent in the stocking group with fewer in the inelastic compression bandage group and fewest in the eccentric compression group. A further study has been published by another author in which elastic compression has been compared with eccentric compression following endovenous laser ablation of the saphenous vein. Eccentric compression reduced postoperative pain. Unfortunately, very little data are available to indicate the period for which compression should be applied following varicose vein treatment. CONCLUSIONS: In comparison to compression treatments following varicose vein surgery where the actual level of compression has been measured, higher levels of compression are more effective than lower levels in moderating postoperative pain and complications. Strong compression can be achieved by inelastic bandaging or by eccentric compression systems. Far fewer data are available to indicate the duration for which postoperative compression is required.

Wound care in venous ulcers.

Wound dressings: ulcer dressings should create and maintain a moist environment on the ulcer surface. It has been shown that in an ulcer with a hard crust and desiccated bed, the healing process is significantly slowed and sometimes completely blocked so favouring infection, inflammation and pain. In contrast a moist environment promotes autolytic debridement, angiogenesis and the more rapid formation of granulation tissue, favours keratinocytes migration and accelerates healing of wounds. Apart from these common characteristics, wound dressings are completely different in other aspects and must be used according to the ulcer stage. In necrotic ulcers, autolytic debridement by means of hydrogel and hydrocolloids or with enzymatic paste is preferred. In case of largely exuding wounds alginate or hydrofibre are indicated. When bleeding occurs alginate is indicated due to its haemostatic power. Where ulcers are covered by granulation tissue, polyurethane foams are preferred. When infection coexists antiseptics are necessary: dressing containing silver or iodine with large antibacterial spectrum have proved to be very effective. In the epithelization stage polyurethane films or membranes, thin hydrocolloids or collagen based dressings are very useful to favour advancement of the healing wound edge. Despite these considerations, a Cochrane review failed to find advantages for any dressing type compared with low-adherent dressings applied beneath compression. Surgical debridement and grafting of wounds, negative wound pressure treatment: surgical and hydrosurgical debridement are indicated in large, necrotic and infected wounds as these treatments are able to get rid of necrotic, infected tissue very quickly in a single surgical session, thereby significantly accelerating wound bed preparation and healing time. Negative wound pressure treatment creating a negative pressure on ulcer bed is able to favour granulation tissue and shorten healing time. In case of hard-to-heal leg ulcers such as large, deep, infected and long-lasting venous ulcers, sharp debridement and skin grafting may favour and shorten ulcer healing.

Occupational leg oedema is more reduced by antigraduated than by graduated stockings.

INTRODUCTION: Elastic compression stockings exerting a progressive pressure, higher at the calf than at the ankle (progressive elastic compression stockings, PECS), have already proved to be more comfortable, easier to put on and more effective in improving venous pumping function compared to graduated compression elastic stockings (GECS). Nevertheless, PECS could have a negative effect on the prevention and treatment of oedema or even favour oedema formation. The aim of the present study was to investigate if, in normal volunteers, PECS are able to prevent leg swelling during their working shift. METHODS: A total of 30 normal volunteers (14 males, 16 females aged 36.4 ± 6.6 years) staying standing or sitting during their shift were enrolled into the study. Their leg volume was measured at the beginning and at the end of their working shift on 2 consecutive days. On one day, the volunteers did not put on any stockings; on the other day, they wore GECS on one leg and PECS on the other. The difference between the leg volume measured at the end of the shift and the basal volume in the morning was called 'occupational oedema'. Interface pressure at points B1 and C was measured immediately after stockings' application and before removal. The volunteers were asked to report about difficulty of putting on the stockings and comfort during wearing time. The results were submitted to statistical analysis. RESULTS: The GECS and PECS groups had similar baseline leg volumes (3143 vs. 3154 ml) and occupational oedema (134 vs. 137.5 ml); after putting on the stockings, occupational oedema was reduced in both legs but the reduction was significantly greater with PECS (20 vs. 40 ml with GECS) (P < 0.05). Interface pressure at ankle level is higher with GECS both in supine and in standing position while at calf level it is higher with PECS both in supine and standing position. PECS are easier to put on and slightly more comfortable. CONCLUSION: PECS are easier to put on and more comfortable and produce a significantly higher reduction of occupational oedema compared with GECS in normal volunteers. Nevertheless leg volumetry, providing a global leg-volume evaluation, is not able to localise the oedema reduction and to assess if it occurs more in the calf or the ankle area. Theoretically, despite a global volume reduction, PECS could even promote a slight oedema formation at ankle level over-compensated by a greater oedema reduction at calf level. Further studies need to concentrate on patients with venous disease and on the local distribution of this global effect.

High compression pressure over the calf is more effective than graduated compression in enhancing venous pump function.

BACKGROUND: Graduated compression is routinely employed as standard therapy for chronic venous insufficiency. AIM: The study aims to compare the haemodynamic efficiency of a multi-component graduated compression bandage (GCB) versus a negative graduated compression bandage (NGCB) applied with higher pressure over the calf. METHODS: In 20 patients, all affected by greater saphenous vein (GSV) incompetence and candidates for surgery (Clinical, etiologic, anatomic and pathophysiologic data, CEAP C2-C5), the ejection fraction of the venous calf pump was measured using a plethysmographic method during a standardised walking test without compression, with GCB and NGCB, all composed of the same short-stretch material. Sub-bandage pressures were measured simultaneously over the distal leg and over the calf. RESULTS: NGCBs with median pressures higher at the calf (62 mmHg) than at the distal leg (50 mmHg) achieved a significantly higher increase of ejection fraction (median +157%) compared with GCB, (+115%) with a distal pressure of 54 mmHg and a calf pressure of 28 mmHg (P < 0.001). CONCLUSIONS: Patients with severe venous incompetence have a greater haemodynamic benefit from NGCB, especially during standing and walking, than from GCB.

Chronic edema of the lower extremities: international consensus recommendations for compression therapy clinical research trials.

Chronic edema is a multifactorial condition affecting patients with various diseases. Although the pathophysiology of edema varies, compression therapy is a basic tenant of treatment, vital to reducing swelling. Clinical trials are disparate or lacking regarding specific protocols and application recommendations for compression materials and methodology to enable optimal efficacy. Compression therapy is a basic treatment modality for chronic leg edema; however, the evidence base for the optimal application, duration and intensity of compression therapy is lacking. The aim of this document was to present the proceedings of a day-long international expert consensus group meeting that examined the current state of the science for the use of compression therapy in chronic edema. An expert consensus group met in Brighton, UK, in March 2010 to examine the current state of the science for compression therapy in chronic edema of the lower extremities. Panel discussions and open space discussions examined the current literature, clinical practice patterns, common materials and emerging technologies for the management of chronic edema. This document outlines a proposed clinical research agenda focusing on compression therapy in chronic edema. Future trials comparing different compression devices, materials, pressures and parameters for application are needed to enhance the evidence base for optimal chronic oedema management. Important outcomes measures and methods of pressure and oedema quantification are outlined. Future trials are encouraged to optimize compression therapy in chronic edema of the lower extremities.