Oxpentifylline treatment of venous ulcers of the leg.

OBJECTIVE--To determine the effect of oxpentifylline on the healing of venous ulcers of the leg. DESIGN--Double blind, randomised, prospective, placebo controlled, parallel group study. SETTING--Four outpatient clinics treating leg ulcers in England and the Republic of Ireland. PATIENTS--80 Consecutive patients with clinical evidence of venous ulceration of the leg in whom appreciable arterial disease was excluded by the ratio of ankle to brachial systolic pressure being greater than 0.8. INTERVENTIONS--All patients received either oxpentifylline 400 mg three times a day by mouth or a matching placebo for six months (or until their reference ulcer healed if this occurred sooner) in addition to a locally standardised method of compression bandaging. MAIN OUTCOME MEASURES--The primary end point was complete healing of the reference ulcer within six months. The secondary end point was the change in the area of the ulcer over the six month observation period. RESULTS--Complete healing of the reference ulcer occurred in 23 of the 38 patients treated with oxpentifylline and in 12 of the 42 patients treated with a placebo. Life table analysis showed that the proportion of ulcers healed at six months was 64% in the group treated with oxpentifylline compared with 34% in the group treated with a placebo (log rank test chi 2 = 4.78, p = 0.03), which was significant (odds ratio = 1.81, 95% confidence interval 1.20 to 2.71). CONCLUSION--Oxpentifylline used in conjunction with compression bandaging improves the healing of venous ulcers of the leg.     

Cost effectiveness of community leg ulcer clinics: randomised controlled trial

Objectives: To establish the relative cost effectiveness of community leg ulcer clinics that use four layer compression bandaging versus usual care provided by district nurses. Design: Randomised controlled trial with 1 year of follow up. Setting: Eight community based research clinics in four trusts in Trent. Subjects: 233 patients with venous leg ulcers allocated at random to intervention (120) or control (113) group. Interventions: Weekly treatment with four layer bandaging in a leg ulcer clinic (clinic group) or usual care at home by the district nursing service (control group). Main outcome measures: Time to complete ulcer healing, patient health status, and recurrence of ulcers. Satisfaction with care, use of services, and personal costs were also monitored. Results: The ulcers of patients in the clinic group tended to heal sooner than those in the control group over the whole 12 month follow up (log rank P=0.03). At 12 weeks, 34% of patients in the clinic group were healed compared with 24% in the control. The crude initial healing rate of ulcers in intervention compared with control patients was 1.45 (95% confidence interval 1.04 to 2.03). No significant differences were found between the groups in health status. Mean total NHS costs were £878.06 per year for the clinic group and £859.34 for the control (P=0.89). Conclusions: Community based leg ulcer clinics with trained nurses using four layer bandaging is more effective than traditional home based treatment. This benefit is achieved at a small additional cost and could be delivered at reduced cost if certain service configurations were used.

Key messages

• Leg ulcer clinics based in the community using four layer compression bandaging can be more clinically effective than usual care provided by the district nursing service
• Community based leg ulcer clinics could be provided more cost effectively than usual home based care for venous leg ulcers
• Recurrence of venous leg ulcers is an important variable that should be measured in future trials of venous leg ulcer care
• It is difficult to measure improvements in health related quality of life among people with venous leg ulcers

     

Community leg ulcer clinics: a comparative study in two health authorities.

OBJECTIVE--To compare the outcome and cost of care for leg ulcers in community leg ulcer clinics in Stockport District Health authority with Trafford District Health Authority as a control. DESIGN--Detailed cost and efficacy studies conducted prospectively over a three month period in both districts both before and one year after the introduction of five leg ulcer clinics in Stockport. SETTING--Two large district health authorities of broad socioeconomic mix and total population of 540,000. PATIENTS--All patients receiving treatment for an active leg ulcer, irrespective of the profession or location of their carer. MAIN OUTCOME MEASURES--The proportion of ulcerated limbs completely healed within three months and total cost of leg ulcer care. RESULTS--The introduction of community clinics in Stockport improved healing of leg ulcers from 66/252 (26%) in 1993 to 99/233 (42%) in 1994 (P < 0.001) compared with in Trafford, where 47/203 (23%) healed in 1993 and only 43/213 (20%) in 1994. This improved result in Stockport was achieved while the annual expenditure on care of leg ulcers was reduced from 409,991 pounds to only 253,371 pounds. In the same year the cost of leg ulcer care in Trafford increased from 556,039 pounds to 673,318 pounds. CONCLUSION--In the first year after the introduction of community clinics, before most patients in Stockport had access to these clinics, healing of leg ulcers was already improved whereas costs were reduced.     

Venous leg ulcers: a prognostic index to predict time to healing.

OBJECTIVE--To evaluate the prognostic factors in uncomplicated venous leg ulcer healing. DESIGN--Randomised parallel group controlled trial with subjects stratified by initial ulcer diameter and four months'' maximum duration of follow up. SETTING--Assessment at Northwick Park Hospital vascular unit with community based treatment. PATIENTS--200 patients with clinical and objective evidence of uncomplicated venous leg ulceration and an initial ulcer diameter > 2 cm. MAIN OUTCOME MEASURE--Time to complete healing of the ulcer. RESULTS--In the presence of graduated compression healing occurred more rapidly in patients with a smaller initial ulcer area (relative risk of healing 1.92 associated with halving of ulcer area (95% confidence interval 1.58 to 2.33)), shorter duration of ulceration (relative risk 1.35 associated with halving duration (1.17 to 1.56)), younger age (relative risk 1.34 associated with 10 year decrease (1.12 to 1.59)), and no deep vein involvement (relative risk 1.8 (1.19 to 2.78)). CONCLUSION--These prognostic factors used in a simple scoring system predict time to healing.     

Investigation of the Effect of Deprivation on the Burden and Management of Venous Leg Ulcers: A Cohort Study Using the THIN Database

Background

There has been limited examination of the contribution of socio-economic factors to the development of leg ulcers, despite the social patterning of many underlying risk factors. No previous studies were found that examined social patterns in the quality of treatment received by patients with leg ulcers.

Methods

Using The Health Improvement Network (THIN) database we identified a cohort of over 14000 patients with a diagnosis of venous leg ulceration, prospectively recorded between the years 2001 and 2006, with linked area-level socio-economic information (Townsend deprivation quintile). We assessed socio-economic differences in the incidence and prevalence of leg ulcers using negative binomial regression. Socio-economic differences in two key areas of guideline recommended leg ulcer management, arterial Doppler assessment and compression bandaging, were assessed using multilevel regression.

Results

The risk of incident venous leg ulceration increased for patients living in areas of higher deprivation, even after adjustment for known risk factors age and gender. Overall reported rates of Doppler assessment and provision of compression therapy were low, with less than sixteen per cent of patients having a database record of receiving these recommended diagnostic and treatment options. Patients diagnosed with incident venous leg ulcers living in the most deprived areas were less likely to receive the recommended Doppler-aided assessment for peripheral vascular disease than patients living in the least deprived areas (odds ratio 0.43, 95% confidence interval 0.24–0.78). Documented provision of compression therapy did not vary with deprivation.

Conclusions

A socio-economic gradient in venous leg ulcer disease was observed. The overall rates of people with venous leg ulcers who were documented as receiving guideline recommended care (2001–2006) were low. Reported use of Doppler ultrasound assessment was negatively associated with socio-economic status. These findings suggest that the inequalities experienced by leg ulcer patients may be exacerbated by reduced access to guideline-based management.     

Arterial disease in chronic leg ulceration: an underestimated hazard? Lothian and Forth Valley leg ulcer study.

Six hundred patients with chronic leg ulcers were interviewed and examined for evidence of arterial impairment. There were 827 ulcerated legs. Pedal pulses could not be felt in 94 (11%). A Doppler resting pressure index of 0.9 or less was found in 176 legs (21%). Risk factors for arterial impairment included age, ulceration affecting the foot, and a history of claudication, ischaemic heart disease, or cerebrovascular disease. Roughly half the patients with arterial impairment also showed the clinical features of chronic venous insufficiency. Careful assessment for arterial disease is mandatory before patients with chronic leg ulcers are treated with elastic compression.     

Pinch skin grafting or porcine dermis in venous ulcers: a randomised clinical trial.

Chronic venous ulcers are common, and even with effective compression or elevation large ulcers may take months to heal. Pinch skin grafting may allow healing from epithelial islands throughout the surface area of the ulcer, and a prospective randomised trial was therefore conducted comparing this treatment with porcine dermis dressings. Most patients were treated as outpatients, 25 ulcers being randomised to treatment with pinch skin grafts and 28 to treatment with porcine dermis. Though the groups were well matched, the mean healing rate in the first week was 15 cm2 for pinch skin grafts compared with 3.5 cm2 with porcine dermis (p less than 0.02). By life table analysis 64% of ulcers treated by pinch grafts were healed at six weeks and 74% by 12 weeks compared with 29% and 46% of ulcers, respectively, treated with porcine dermis dressings (chi2 = 4.1; p less than 0.05). All ulcers that failed to heal within 12 weeks included an area posterior to the medial malleolus, where local compression may have been inadequate. Pinch skin grafting improves the rate of healing in large venous ulcers and is a simple technique that may be performed as an outpatient procedure under local anaesthesia.     

Randomised,double blind placebo controlled trial of pentoxifylline in the treatment of venous leg ulcers

ObjectiveTo determine whether pentoxifylline 400 mg (Trental 400) taken orally three times daily, in addition to ambulatory compression bandages and dressings, improves the healing rate of pure venous ulcers.DesignRandomised, double blind placebo controlled trial, parallel group study of factorial design, permitting the simultaneous evaluation of alternative pharmaceutical, bandaging, and dressings materials.SettingLeg ulcer clinics of a teaching and a district general hospital in southern Scotland.Participants200 patients with confirmed venous ulcers and in whom other major causal factors were excluded.InterventionsPentoxifylline 400 mg three times daily or placebo.ResultsComplete healing occurred in 65 of the 101 (64%) patients receiving pentoxifylline and 52 of the 99 (53%) patients receiving placebo.ConclusionsThe difference in the healing rates between patients taking pentoxifylline and those taking placebo did not reach statistical significance.

Key messages

• Leg ulcers cost the NHS around £400 million per annum
• 50%-75% of venous leg ulcers can be succesfully treated with dressings and compression bandages but take many months to heal
• A drug that reduced the healing time of venous ulcers would be useful, although no agent has been proved to be effective to date
• Trials with pentoxifylline, a vasoactive drug used in the treatment of peripheral vascular diseases, as an adjunct to the treatment of venous ulcers have been inconclusive
• At the 5% level, pentoxifylline had a non-significant effect on healing rates of pure venous ulcers

     

The Use of Biatain Ag in Hard-to-Heal Venous Leg Ulcers: Meta-Analysis of Randomised Controlled Trials

Background

Venous leg ulcers are common, troublesome, and their failure to heal is often related to a heavy bio-burden. Ionized silver has both anti-inflammatory and antimicrobial properties. The ulcer healing properties of the silver releasing foam dressing Biatain Ag has been examined in 4 randomized controlled trials (RCTs).

Aim

To evaluate ulcer healing through a meta-analytic approach after treatment with either Biatain Ag or a non-active dressing.

Patients and Methods

685 subjects with pure or mixed hard-to-heal venous leg ulcers were included in the meta-analysis.

Results

Biatain Ag showed a significant treatment effect (p<0.0001), responder rate (p<0.001), and healing rate (p = 0.002).

Conclusion

The meta-analysis of the 4 RCTs provided statistical significant evidence to support the use of Biatain Ag dressing in treatment of hard-to-heal venous leg ulcers.     

Success rate of split-thickness skin grafting of chronic venous leg ulcers depends on the presence of Pseudomonas aeruginosa: a retrospective study

The last years of research have proposed that bacteria might be involved in and contribute to the lack of healing of chronic wounds. Especially it seems that Pseudomonas aeruginosa play a crucial role in the healing. At Copenhagen Wound Healing Centre it was for many years clinical suspected that once chronic venous leg ulcers were colonized (weeks or months preoperatively) by P. aeruginosa, the success rate of skin grafting deteriorated despite aggressive treatment. To investigate this, a retrospective study was performed on the clinical outcome of 82 consecutive patients with chronic venous leg ulcers on 91 extremities, from the 1^st of March 2005 until the 31^st of August 2006. This was achieved by analysing the microbiology, demographic data, smoking and drinking habits, diabetes, renal impairment, co-morbidities, approximated size and age of the wounds, immunosuppressive treatment and complicating factors on the clinical outcome of each patient. The results were evaluated using a Student T-test for continuous parameters, chi-square test for categorical parameters and a logistic regression analysis to predict healing after 12 weeks. The analysis revealed that only 33,3% of ulcers with P. aeruginosa, isolated at least once from 12 weeks prior, to or during surgery, were healed (98% or more) by week 12 follow-up, while 73,1% of ulcers without P. aeruginosa were so by the same time (p = 0,001). Smoking also significantly suppressed the outcome at the 12-week follow-up. Subsequently, a logistic regression analysis was carried out leaving P. aeruginosa as the only predictor left in the model (p = 0,001). This study supports our hypothesis that P. aeruginosa in chronic venous leg ulcers, despite treatment, has considerable impact on partial take or rejection of split-thickness skin grafts.     

Randomised double blind controlled study of recurrence of gastric ulcer after treatment for eradication of Helicobacter pylori infection.

OBJECTIVE: To determine whether eradication of Helicobacter pylori infection reduces recurrence of benign gastric ulceration. DESIGN: Randomised, double blind, controlled study. Patients were randomised in a 1:2 ratio to either omeprazole 40 mg once daily for eight weeks or the same treatment plus amoxycillin 750 mg twice daily for weeks 7 and 8. A 12 month untreated follow up ensued. SETTING: Teaching and district general hospitals between 1991 and 1994. SUBJECTS: 107 patients with benign gastric ulcer associated with H pylori. MAIN OUTCOME MEASURES: Endoscopically confirmed relapse with gastric ulcer (analysed with life table methods), H pylori eradication, and healing of gastric ulcers (Mantel-Haenszel test). RESULTS: 172 patients were enrolled. Malignancy was diagnosed in 19; 24 were not infected with H pylori; four withdrew because of adverse events; and 18 failed to attend for start of treatment, leaving 107 patients eligible for analysis (35 omeprazole alone; 72 omeprazole plus amoxycillin). In the omeprazole/amoxycillin group 93% (67/72; 95% confidence interval 84% to 98%) of gastric ulcers healed and 83% (29/35; 66% to 94%) in the omeprazole group (P = 0.103). Eradication of H pylori was 58% (42/72; 46% to 70%) and 6% (2/35; 1% to 19%) (P < 0.001) and relapse after treatment was 22% (16/72) and 49% (17/35) (life table analysis, P < 0.001), in the two groups, respectively. The recurrence rates were 7% (3/44) after successful H pylori eradication and 48% (30/63) in those who continued to be infected (P < 0.001). CONCLUSIONS: Eradication of H pylori reduces relapse with gastric ulcer over one year. Eradication rates achieved with this regimen, however, are too low for it to be recommended for routine use.     

Sustained compression and healing of chronic venous ulcers.

STUDY OBJECTIVE--Comparison of four layer bandage system with traditional adhesive plaster bandaging in terms of (a) compression achieved and (b) healing of venous ulcers. DESIGN--Part of larger randomised trial of five different dressings. SETTING--Outpatient venous ulcer clinic in university hospital. PATIENTS--(a) Pressure exerted by both bandage systems was measured in the same 20 patients. (b) Healing with the four layer bandage was assessed in 148 legs in 126 consecutive patients (mean age 71 (SE 2); range 30-96) with chronic venous ulcers that had resisted treatment with traditional bandaging for a mean of 27.2 (SE 8) months. INTERVENTIONS--(a) Four layer bandage system or traditional adhesive plaster bandaging for pressure studies; (b) four layer bandaging applied weekly for studies of healing. END POINTS--(a) Comparison of pressures achieved at the ankle for up to one week; (b) complete healing within 12 weeks. MEASUREMENTS AND MAIN RESULTS--(a) Four layer bandage produced higher initial pressures at the ankle of 42.5 (SE 1) mm Hg compared with 29.8 (1.8) for the adhesive plaster (p less than 0.001; 95% confidence interval 18.5 to 6.9). Pressure was maintained for one week with the four layer bandage but fell to 10.4 (3.5) mm Hg at 24 hours with adhesive plaster bandaging. (b) After weekly bandaging with the four layer bandage 110 of 48 venous ulcers had healed completely within 12 (mean 6.3 (0.4)) weeks. CONCLUSION--Sustained compression of over 40 mm Hg achieved with a multilayer bandage results in rapid healing of chronic venous ulcers that have failed to heal in many months of compression at lower pressures with more conventional bandages.     

Healing of gastric ulcers after one,two, and three months of ranitidine.

Ranitidine (150 mg twice daily) was compared with placebo in 42 patients with gastric ulcer. The study was conducted as a double-blind trial for one month, followed by an open assessment of one, two, and three months of ranitidine in the patients with persistent ulceration. Thirty-eight patients completed the double-blind trial. Repeat endoscopy confirmed complete healing in 16 of the 21 who had received ranitidine and five of the 17 who had received placebo (p less than 0.01). The remaining 17 patients with persistent ulceration participated in the open assessment. The combined cumulative healing rates of ranitidine at four, eight, and 12 weeks were 73%, 88%, and 97%. There were no adverse effects or unusual reasons for withdrawal from the study (four patients). Ranitidine appears to be a safe and highly effective treatment of gastric ulceration, with about 90% of ulcers healed after eight weeks.     

Long term management of duodenal ulcer in general practice: How best to use cimetidine?

Two hundred and sixty seven patients with duodenal ulceration were entered into a five year study of two strategies of treatment with cimetidine. Two thirds were treated continuously with 400 mg at bedtime supplemented by temporary increases in dosage if they had symptomatic relapses (group 1), and the remaining third were given intermittent “healing” doses for four to eight weeks if a symptomatic recurrence was judged to have occurred (group 2). Life table analysis showed that the probability of remaining free of clinically important symptoms five years after the start of treatment was 24% (95% confidence interval (CI) 15·5% to 32·6%) in group 1 compared with nil in group 2 (p<0·0001). The median values for the longest periods free from relapse for each patient were 108 weeks in group 1 and 32 weeks in group 2, respectively (p<0·0001; 95% CI of the median difference 36 to 76). Over the five years 10 patients suffered major complications, two requiring emergency surgery, while a further nine had elective surgery because of the failure of medical treatment. There were no deaths that could be attributed either to ulceration or to treatment with cimetidine.Medical management was therefore very satisfactory for most patients, though those treated continuously with cimetidine suffered considerably less from their ulcer symptoms. As 80% of patients studied relapsed during the two years after a healing course of cimetidine, continuous treatment will benefit many patients treated in general practice.     

A systematic review of compression treatment for venous leg ulcers.

OBJECTIVE: To estimate the clinical and cost effectiveness of compression systems for treating venous leg ulcers. METHODS: Systematic review of research. Search of 19 electronic databases including Medline, CINAHL, and Embase. Relevant journals and conference proceedings were hand searched and experts were consulted. MAIN OUTCOME MEASURES: Rate of healing and proportion of ulcers healed within a time period. STUDY SELECTION: Randomised controlled trials, published or unpublished, with no restriction on date or language, that evaluated compression as a treatment for venous leg ulcers. RESULTS: 24 randomised controlled trials were included in the review. The research evidence was quite weak: many trials had inadequate sample size and generally poor methodology. Compression seems to increase healing rates. Various high compression regimens are more effective than low compression. Few trials have compared the effectiveness of different high compression systems. CONCLUSIONS: Compression systems improve the healing of venous leg ulcers and should be used routinely in uncomplicated venous ulcers. Insufficient reliable evidence exists to indicate which system is the most effective. More good quality randomised controlled trials in association with economic evaluations are needed, to ascertain the most cost effective system for treating venous leg ulcers.     

Clinical Unity and Community Empowerment: The Use of Smartphone Technology to Empower Community Management of Chronic Venous Ulcers through the Support of a Tertiary Unit

Background

Chronic ulcers affect roughly 60,000 Irish people, at a total cost of €600,000,000, or €10,000 per patient annually. By virtue of their chronicity, these ulcers also contribute a significant burden to tertiary outpatient vascular clinics.

Objective

We propose utilizing mobile phone technology to decentralise care from tertiary centres to the community, improving efficiency and patient satisfaction, while maintaining patient safety.

Methods

Bespoke mobile software was developed for Apples iPhone 4 platform. This allowed for the remote collection of patient images prospectively and their transmission with clinical queries, from the primary healthcare team to the tertiary centre. Training and iPhones were provided to five public health nurses in geographically remote areas of the region. Data were uploaded securely and user end software was developed allowing the review and manipulation of images, along with two way communication between the teams. Establishing reliability, patients were reviewed clinically as well as remotely, and concordance analysed. Qualitative data were collected through focus group discussion.

Results

From October to December 2011 eight patients (61–83 yrs, mean 75.3 yrs) with chronic venous ulceration and their five public health nurses were recruited. Data were transmitted using 3 G, Edge, GPRS and WiFi, at a mean speed of 69.03 kps. Concordance was 100% for wound bed assessment, 80% for skin integrity/colour and 60% for exudate assessment. Focus group analysis explored the concept, practicalities and future applications of the system.

Conclusions

With an evolving national data network, the secure transmission of clinical images is a safe alternative to regular clinic appointments for patients with chronic venous ulceration. With further development, and packaged as a freely downloadable application, this has the potential to support the community care of chronic wounds.     

Is there a place in the United Kingdom for intensive antacid treatment for chronic peptic ulceration?

Sixty nine patients with chronic duodenal or juxtapyloric ulceration were studied in a prospective double blind randomised trial to compare the efficacy of antacid and placebo at high (30 ml seven times daily) and low (10 ml as required) doses. After four weeks ulcers had healed in 12 out of 18 patients (67%) receiving "low dose" antacid compared with in six out of 17 patients (35%) receiving low dose placebo; ulcers had also healed in six out of 19 patients (32%) receiving "high dose" antacid compared with in two out of 15 patients (13%) receiving high dose placebo. Overall, the effect of antacid was superior to that of placebo in healing ulcers (p less than 0.05) and the effect of low dose treatment was superior to that of high dose treatment (p less than 0.01). There were no significant differences between antacid and placebo at eight weeks. Antacid was better than placebo in relieving pain, but the difference was not significant. Poor compliance and high incidence of diarrhoea made high dose antacid an impractical treatment. Low dose antacid was associated with a significantly better rate of healing than high dose antacid and was far better tolerated. This low dosage of antacid should be considered to be an active treatment in trials of ulcer healing.     

Incidence,Clinical Spectrum,Risk Factors and Impact of HIV-Associated Immune Reconstitution Inflammatory Syndrome in South Africa

Background

Immune reconstitution inflammatory syndrome (IRIS) is a widely recognised complication of antiretroviral therapy (ART), but there are still limited data from resource-limited settings. Our objective was to characterize the incidence, clinical spectrum, risk factors and contribution to mortality of IRIS in two urban ART clinics in South Africa.

Methods and Findings

498 adults initiating ART in Durban, South Africa were followed prospectively for 24 weeks. IRIS diagnosis was based on consensus expert opinion, and classified by mode of presentation (paradoxical worsening of known opportunistic infection [OI] or unmasking of subclinical disease). 114 patients (22.9%) developed IRIS (36% paradoxical, 64% unmasking). Mucocutaneous conditions accounted for 68% of IRIS events, mainly folliculitis, warts, genital ulcers and herpes zoster. Tuberculosis (TB) accounted for 25% of IRIS events. 18/135 (13.3%) patients with major pre-ART OIs (e.g. TB, cryptococcosis) developed paradoxical IRIS related to the same OI. Risk factors for this type of IRIS were baseline viral load >5.5 vs. <4.5 log₁₀ (adjusted hazard ratio 7.23; 95% confidence interval 1.35–38.76) and ≤30 vs. >30 days of OI treatment prior to ART (2.66; 1.16–6.09). Unmasking IRIS related to major OIs occurred in 25/498 patients (5.0%), and risk factors for this type of IRIS were baseline C-reactive protein ≥25 vs. <25 mg/L (2.77; 1.31–5.85), haemoglobin <10 vs. >12 g/dL (3.36; 1.32–8.52), ≥10% vs. <10% weight loss prior to ART (2.31; 1.05–5.11) and mediastinal lymphadenopathy on pre-ART chest x-ray (9.15; 4.10–20.42). IRIS accounted for 6/25 (24%) deaths, 13/65 (20%) hospitalizations and 10/35 (29%) ART interruptions or discontinuations.

Conclusion

IRIS occurred in almost one quarter of patients initiating ART, and accounted for one quarter of deaths in the first 6 months. Priority strategies to reduce IRIS-associated morbidity and mortality in ART programmes include earlier ART initiation before onset of advanced immunodeficiency, improved pre-ART screening for TB and cryptococcal infection, optimization of OI therapy prior to ART initiation, more intensive clinical monitoring in initial weeks of ART, and education of health care workers and patients about IRIS.     

Leg-ulcer care in the community,before and after implementation of an evidence-based service

Background

Leg ulcers usually occur in older patients, a growing population for which increasing health care resources are required. Treatment is mainly provided in patients'' homes; however, patients often receive poorly integrated services in multiple settings. We report the results of a prospective study of a community-based care strategy for leg ulcers.

Methods

International practice recommendations and guidelines were adapted to make a new clinical protocol. The new model, for a dedicated service staffed by specially trained registered nurses, established initial and ongoing assessment time frames and provided enhanced linkages to medical specialists. Data were collected for 1 year before and after implementation; outcome measures included 3-month healing rates, quality of life and resource usage.

Results

Three-month healing rates more than doubled between the year before implementation (23% [18/78]) and the year afterward (56% [100/180]). The number of nursing visits per case declined, from a median of 37 to 25 (p = 0.041); the median supply cost per case was reduced from $1923 to $406 (p = 0.005).

Interpretation

Reorganization of care for people with leg ulcers was associated with improved healing and a more efficient use of nursing visits.Although not always recognized as a pressing health care problem, leg ulcers are a common, complex, and costly condition. International studies have shown that their occurrence increases with age.^1,2,3,4,5 Chronic ulcers are an ongoing burden to patients and to the health care system.^6,7,8,9,10 Patients tend to receive poorly integrated services in multiple settings.The Ottawa Community Care Access Centre, an eastern Ontario home-care authority, observed a pattern of yearly increases in the resources required to care for people with chronic wounds. Researchers from Queen''s University, Ottawa University and 3 nursing agencies undertook a comprehensive regional needs assessment to understand the population and the care environment. They documented an estimated prevalence of 1.8 cases of leg ulcer per 1000 population, an incidence comparable to rates reported from other countries.¹¹Profile information revealed a population complex in terms of health problems and care challenges. Most patients were over 65 years in age; nearly three-quarters had 3 or more other conditions. Over two-thirds had experienced leg ulcers for many months. Half of the affected population had a leg-ulcer history spanning 5–10 years; a third, exceeding 10 years. Our 4-week costing study¹² estimated that 192 people receiving care would annually consume $1 million in nursing care services and $260 000 in wound-care supplies.Home care nurses and family physicians had varying levels of confidence in managing patients with leg ulcers.^13,14 In general, they were unaware of the relative effectiveness of compression therapy for venous leg ulcers, i.e., that 1 of 6 patients so treated would heal (95% confidence interval [CI] 4–18).^15,16 Practice audits indicated that assessments were not standardized: ultrasound readings of the ankle brachial pressure index (measured with a hand-held Doppler) to rule out arterial disease were not routine; serial measurements of ulcers were carried out inconsistently; and compression bandaging, the standard of care for venous ulcers, was underutilized and yet also occasionally applied inappropriately to ulcers with arterial involvement.¹⁷The researchers and organizations involved collaborated and fed information back and forth, generating regional data which, when combined with available external evidence, provided information appropriate to the local community. Regional decision-makers agreed to a redesign of the delivery of care to these patients, based on that information. This involved changing to a nurse-led service providing clinical care in accordance with a set of evidence-based guidelines.^18,19,20 The objective of our study was to determine and compare the health outcomes and efficiencies of the former and new services.     

Blood Viscosity and the Expression of Inflammatory and Adhesion Markers in Homozygous Sickle Cell Disease Subjects with Chronic Leg Ulcers

Objective

To determine differences in TNF-α, IL-1β, IL-10, sICAM-1 concentrations, leg hypoxia and whole blood viscosity (WBV) at shear rates of 46 sec^-1 and 230 sec^-1 in persons with homozygous S sickle cell disease (SCD) with and without chronic leg ulceration and in AA genotype controls.

Design

& Methods: fifty-five age-matched participants were recruited into the study: 31 SS subjects without leg ulcers (SS_n), 24 SS subjects with leg ulcers (SS_u) and 18 AA controls. Haematological indices were measured using an AC.Tron Coulter Counter. Quantification of inflammatory, anti-inflammatory and adhesion molecules was performed by ELISA. Measurement of whole blood viscosity was done using a Wells Brookfield cone-plate viscometer. Quantification of microvascular tissue oxygenation was done by Visible Lightguide spectrophotometry.

Results

TNF-α and whole blood viscosity at 46 sec^-1 and 230 sec^-1 (1.75, 2.02 vs. 0.83, 1.26, p<0.05) were significantly greater in sickle cell disease subjects than in controls. There were no differences in plasma concentration of sICAM-1, IL-1β and IL-10 between SCD subjects and controls. IL-1β (median, IQR: 0.96, 1.7 vs. 0, 0.87; p<0.01) and sICAM-1 (226.5, 156.48 vs. 107.63, 121.5, p<0.005) were significantly greater in SS_u group compared with SS_n. However there were no differences in TNF-α (2, 3.98 vs. 0, 2.66) and IL-10 (13.34, 5.95 vs. 11.92, 2.99) concentrations between SS_u and SS_n. WBV in the SS_u group at 46 sec^-1 and at 230 Sec 1 were 1.9 (95%CI; 1.2, 3.1) and 2.3 (1.2, 4.4) times greater than in the SS_n group. There were no differences in the degree of tissue hypoxia as determined by lightguide spectrophotometry.

Conclusion

Inflammatory, adhesion markers and WBV may be associated with leg ulceration in sickle cell disease by way of inflammation-mediated vasoocclusion/vasoconstriction. Impaired skin oxygenation does not appear to be associated with chronic ulcers in these subjects with sickle cell disease.