Prevalence Of Leg Ulcers Research Articles

Leg Ulcers in Sickle Cell Disease Patients Undergoing Hydroxyurea Therapy: Insights from Two Large Cohort Studies

Background The prevalence of leg ulcers in sickle cell disease (SCD) patients without hydroxyurea (HU) treatment varies significantly (1.5% to 27%) across studies (Diagne 2000, Minniti 2021, Kato 2018), and the causal relationship between HU and leg ulcers remains debatable. Some investigators express concerns about an increased risk in patients with prior ulceration undergoing HU treatment (Kersgard 2001, Chaine 2001, Nzouakou 2011) while others report no influence (Brawley 2008, Cackovic 1998, Suresh 2004). HU's potential benefits, including increased hemoglobin (Hb) and fetal hemoglobin (HbF) levels, are thought to improve clinical outcomes, potentially reducing leg ulcer occurrence (Eckman 1996). Concerns are mainly based in reports from, myeloproliferative diseases with cases of leg ulcers in older patients without relevant history after prolonged HU exposure (Sirieix 1999). Methods The non-interventional prospective cohort study, ESCORT-HU, involved 1906 patients (55% adults) from 62 centres in Germany, Greece, Italy, and France, from January 2009 to March 2019. While the main objectives of ESCORT-HU were fulfilled regarding data collection on common safety concerns associated with the use of HU in SCD patients, more detailed documentation of specific long-term risks associated with HU treatment is required. In response, the non-interventional ESCORT-HU extension study was initiated in 2020 in the same countries aiming to deepen knowledge on low incidence and indeterminate risks, including leg ulcers. Around 2000 patients treated with HU are expected to participate over the 5-year study duration. Patients from the initial ESCORT-HU study could participate in the extension for long-term follow-up data. New patients must meet specific criteria with a focus on patients with leg ulcers. Results 1906 patients were included in ESCORT-HU study, and on June 28, 2023, 1860 patients were included in ESCORT-HU extension study, with 1017 new patients not previously enrolled in the first ESCORT-HU study totalling nearly 3000 patients. Demographic data and time of HU exposure for both studies are summarized in Table 1. A total of 117 leg ulcers episodes were reported in 83 patients (4.3%) during ESCORT-HU, while the extension study recorded 88 episodes in 71 patients (3.9%) ( Table 2). Leg ulcers were mostly reported in patients with the SS genotype (over 90%), and predominantly affect adults. Only five children experienced their first episode from 13.0 to 17.7 years old. However, in the extension study, one child presented an episode of leg ulcer before the age of 10. Approximately 15% of cases reported at least one risk factors with local trauma, skin dryness and venous insufficiency being the most frequently cited factors. Reoccurrence of leg ulcers were slightly higher in ESCORT-HU extension (55.7%) compared to ESCORT-HU (48.7%), possibly due to the inclusion of patients with history of leg ulcer in the extension (80% in extension versus 40% in ESCORT-HU). Regarding the relationship with HU, investigators considered 41 % of cases in ESCORT-HU and only 3.4% in the extension related to HU treatment. One plausible reason for confusion among clinicians is that HU can cause skin dryness, a known risk factor associated with leg ulcers. Additionally, it's worth noting that investigators' perceptions may evolve over time. During the extension study, 10.8% of patients had a history of leg ulcers. Clinicians observed that they were not attributed to HU therapy but rather associated with the underlying disease itself. However, in nearly 25% of cases investigators faced difficulty in determining whether the ulcer was related or not to HU therapy. In over 65% of the patients, the outcome was favourable (recovered and not ongoing), with dose reduction or treatment discontinuation in a minority of patients. Conclusion The incidence of leg ulcers in two large cohorts, comprising nearly 3000 patients with prolonged HU treatment, was around 4 %. Leg ulcers pose challenge to continue HU, but the outcome can also be favourable, even with dose increase. Despite a better understanding of the adverse events associated with HU, it remains complex to attribute leg ulcers exclusively to HU. The identification of additional factors or biomarker predisposing to leg ulcers in future large trial is essential.

Compression therapy for NHS inpatients with leg ulcers: a literature review.

Leg ulcers are common, distressing and painful for patients, and are a significant financial burden to healthcare providers. Compression therapy is the mainstay of treatment for venous leg ulceration. Several studies have evaluated leg ulcer management and compression therapy in the community. However, little is known about the prevalence of leg ulceration and use of compression therapy in acute hospitals. The aim of this study was to explore the published literature on the use of compression therapy for inpatients with leg ulcers in UK National Health Service hospital settings. A literature search was undertaken to identify published papers reporting on inpatient leg ulcer populations and the use of compression therapy in hospitals using the following databases: CINAHL, MEDLINE Complete, Embase and PubMed. The literature review identified 364 articles, of which three met the eligibility criteria. These studies reported on the prevalence of leg ulceration, the number of Doppler assessments conducted for patients and the use of compression therapy. This review confirmed a lack of information on the prevalence of hospital inpatients with leg ulcers, and identified the need to conduct prevalence audits, establish leg ulcer services to streamline inpatient leg ulcer care and provide staff and patient education programmes.

INCIDENCE AND ETIOPATHOGENESIS OF LOWER LIMB ULCERSPROSPECTIVE STUDY

Background: An ulcer is a discontinuity in the epithelial surface. Ulcers are wounds with a full-thickness depth and have a varied healing tendency. Ulcers can present with complete loss of the epidermis, loss of the dermis and also loss of subcutaneous fat. Lower limb chronic ulcers are a relatively common condition among adults, which often causes discomforting pain at rest, limits mobility and also brings social distress. It is estimated that the prevalence of active leg ulceration is 0.15%. The aetiology of chronic limb ulcers includes venous disorders, arterial disease and neuropathy. The prevalence of leg ulcers depends on various associated concomitant diseases and also varies geographically and even among ethnic groups. This study is being conducted to assess the factors associate Aims and Objectives: d with lower limb ulcers and its aetiology on the patients admitted to Kanyakumari Government Medical College. The study is carried out on 100 patient Materials and Methods: s with lower limb ulcers admitted to the Department of General Surgery at KGMCH. The Results: study was conducted among 100 patients, with the majority of patients in the age group between 19 and 78 years of age and a mean age of 61. Male predominance was reported in the study, with 67 patients being male. The ankle-brachial pressure index (ABPI) of the study population is between 0.7 and 0.9 for 43% of patients. The study identied that right foot is the most common site involved. Diabetes was the commonest metabolic disorder and present in 40% of the patients 31% of the patients have hypertension. 57% of the study population presented in Wagner's Grade 3 ulcer. The average size of the ulcer at the time of presentation is 4.8 cm2. As the age of people advances, the chances of them getting chronic leg ul Conclusion: cers also proportionately increase. It is also evident that the incidence of ulcers is higher among the male population, as they have more mobility in the outside environment and tend to have more ulcers than the female population. Though systemic diseases like diabetes play a major role as a precipitative metabolic event, leg ulcers are often the leading cause of hospitalisation, loss of mobility, pain and amputation, and incur huge nancial burdens. The chronicity of the problem and its perennial nature always result in an ongoing melody throughout the life span of the individuals. Prevention followed by early appropriate care is the only option that can help get rid of this and avoid the agony of amputation. The newer concepts of wound care, such as vacuum therapy, hyperbaric oxygen therapy, PRP therapy, etc., must be made available at all public hospitals to cater to the needs of these suffering people.

Factors Associated with Leg Ulcers in Adults with Sickle Cell Disease in Brazil.

To define the prevalence of leg ulcers and identify the clinical and laboratory factors associated with leg ulcers in adult participants. The authors conducted a cross-sectional study of 1,109 patients who were 18 years or older with SS or Sβ0-thalassemia genotypes from a Brazilian cohort. Investigators assessed the prevalence of factors associated with leg ulcers from 2013 to 2017. The prevalence of leg ulcers was 21%. Increasing age (odds ratio [OR], 1.07; range, 1.06-1.09), male sex (OR, 2.03; range, 1.44-2.87), treatment with chronic transfusion therapy (OR, 1.88; range, 1.15-3.03), higher indirect bilirubin levels (OR, 1.48; range, 1.02-2.16), and low hemoglobin levels (OR, 2.17; range, 1.52-3.11) were associated with leg ulcers. Participants who self-reported as Black (OR, 6.75; range, 2.63-21.32), mixed (OR, 3.91; range, 1.55-12.20), and other/unknown (OR, 3.84; range, 1.04-15.24) were more likely to have leg ulcers compared with those who self-reported as White. The prevalence of leg ulcers in this Brazilian cohort was higher than the prevalence reported in developed countries. Known factors such as age and male sex were corroborated. The increased bilirubin level and decreased hemoglobin levels among participants with leg ulcers support the hypothesis that hemolysis is correlated with leg ulcer pathogenesis. Self-reported black skin color was an independent predictor of leg ulcers and warrants further study to understand the etiology and implications of this finding.

Leg Ulcer Prevalence and Outcomes in a Real-World, Multicenter, Retrospective Study of Patients Treated with Voxelotor

Background: Sickle cell disease (SCD) is an inherited disorder driven by the polymerization of sickle hemoglobin in the deoxygenated state, leading to chronic hemolytic anemia. Leg ulcers are a severe, chronic, and often recurrent complication of SCD, occurring in about 14% to 18% of patients in the US and more commonly in men and those with severe SCD genotypes. Leg ulcers are painful and decrease physical function, increase pain interference, and cause psychosocial impacts. Symptoms and complications associated with leg ulcers include chronic hemolysis, edema, impaired endothelial function, and venous incompetence and vaso-occlusion. Leg ulcers in SCD are commonly treated with standard wound care, including mechanical/autolytic detersion and modern dressings. Studies on local and systemic treatments have been inconclusive. Voxelotor is a sickle hemoglobin polymerization inhibitor approved in the US for the treatment of SCD in patients aged ≥4 years and in the UK, EU, and UAE for patients aged ≥12 years. Phase 3 clinical trials have shown that voxelotor increases hemoglobin and reduces markers of hemolysis with an overall favorable safety profile. The Retrospective Real World Oxbryta Data Collection and Analysis Study (RETRO) aimed to characterize real-world safety and effectiveness of voxelotor in patients aged ≥12 years. RETRO expands upon our understanding of voxelotor, providing valuable insights and driving future studies that will investigate its descriptive results. Objective: To examine leg ulcer prevalence and outcomes before and during voxelotor treatment in the RETRO study. Methods: RETRO is a post-marketing study designed to collect and characterize real-world, retrospective laboratory and clinical data from patients aged ≥12 years with SCD (all genotypes) treated with voxelotor as part of their usual care. The study was conducted in 9 US sites. Data from patients treated with voxelotor for ≥2 consecutive weeks and with available medical records 1 year before and up to 1 year after their first voxelotor dose were included. Results: A total of 216 patients with a mean (SD) age of 33.5 (14.21) years were included. Overall, 8.8% (19/216) of patients had an active or previous leg ulcer any time during the 1-year period before voxelotor initiation and up to 1-year post-treatment. Of these patients, 57.9% (11/19) reported 1 leg ulcer, and 42.1% (8/19) reported ≥2 leg ulcers; the mean (SD) age of these 19 patients was 40.5 (10.9) years, 36.8% (7/19) were female, and 79.0% (15/19) were Black or African American. Most patients (84.2% [16/19]) had the HbSS genotype, and 57.9% (11/19) were taking hydroxyurea. Five leg ulcers in 4 patients resolved before voxelotor initiation. A total of 23 leg ulcers were ongoing at treatment initiation, meaning the ulcer either occurred before the first dose of voxelotor or occurred after treatment initiation. A total of 14/23 (60.9%) leg ulcers occurred before voxelotor initiation, with half of them (7/14) resolving after voxelotor initiation. The other 9 leg ulcers (39.1% [9/23]) occurred after voxelotor initiation; of these, 5 (55.6%) resolved during voxelotor treatment. Further descriptive analyses of leg ulcer events and resolutions are ongoing. Conclusion: RETRO is the largest multicenter, retrospective study on voxelotor to date. Data reported here describe the prevalence and incidence of leg ulcers in this cohort and the reported outcomes before and during voxelotor treatment. The limitations of this retrospective study include small sample sizes, the reliance on data captured in medical records, and the lack of a control group. To address this gap in knowledge, the RESOLVE study to investigate the impact of voxelotor on leg ulcers is currently underway (PACTR202102669041711). Funding: Global Blood Therapeutics.

Prevalence of people with sickle cell disease and leg ulcers in Brazil: Socioeconomic and clinical overview.

ObjectiveTo identify the prevalence of people with leg ulcers resulting from sickle cell disease, as well as to describe the clinical, social, economic, and demographic conditions of these people.MethodDescriptive study, carried out at the Minas Gerais Hematology and Hemotherapy Center Foundation. The study population consisted of individuals over the age of 18 with a diagnosis of sickle cell disease in the State of Minas Gerais, Brazil. Data collection was performed from August 2019 to April 2020 through interviews. For the prevalence calculation, a census was taken of 5,379 people over the age of 18 with sickle cell disease, 77 of whom had active leg ulcers. Descriptive data analysis was performed using SPSS software (version 20.0, Chicago, IL, USA).ResultsThe prevalence of people with leg ulcers in Minas Gerais, Brazil was 1.4%. Of the 72 respondents, the average age was 39 years (range 18–64 years), 41.7% were single, 48.6% said they were black, 84.7% lived in their own house, 38.9% were retired, 61.1% had an income of one minimum wage. The median years of education was 10.5, 50% cited the church as a place for leisure activities, 79.2% denied smoking. Regarding pain, the median score was 3, the median baseline hemoglobin was 7.7 g/dL, and 91.7% had the HbSS genotype. The median age of the first ulcer was 18 years, 77.8% of active ulcers were recurrent, and 59.7% had only one active ulcer. The median time of existence of the ulcer was 3 years. The ulcer prevented 80.6% of people from doing some activity. Prejudice was experienced by 48.6% of the participants.ConclusionThe estimated prevalence of leg ulcers was lower than what it reported in the literature, however, the recurrence and the duration of ulcers were high. These findings bring reflection about the assistance to people with leg ulcer.

P-059: TRIAL IN PROGRESS: THE RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED PHASE 3 RESOLVE TRIAL INVESTIGATING THE EFFICACY OF VOXELOTOR WITH STANDARD OF CARE IN THE RESOLUTION OF LEG ULCERS IN PATIENTS WITH SICKLE CELL DISEASE

Purpose: Sickle cell disease (SCD) is a heritable blood disorder caused by a point mutation in the β-globin gene. Polymerization of deoxygenated mutated hemoglobin is the major molecular process in SCD pathogenesis that leads to red blood cell sickling and hemolysis. In addition to the major complications of SCD—hemolytic anemia, inflammation, and vascular occlusion—patients often experience secondary complications such as stroke, organ damage, shortened lifespan, and painful and debilitating skin ulcers. The prevalence of leg ulcers among people with SCD is likely underestimated, given the lack of registries and large prospective studies examining this complication. Current estimates of leg ulcers vary widely by geographic region: 43% in Brazil, 30% in Jamaica, 27% in Nigeria, 19% in Ghana, 13% in Sierra Leone, 8% in Saudi Arabia, and 1%-5% in the US. Among Americans with SCD, an estimated 14%-18% may develop leg ulcers. Voxelotor, a sickle hemoglobin polymerization inhibitor, is approved in the US for the treatment of SCD in adults and pediatric patients aged ≥4 years and in the EU for the treatment of hemolytic anemia due to SCD in adults and pediatric patients aged ≥12 years as a monotherapy or in combination with hydroxycarbamide. In a post hoc analysis of voxelotor-treated patients from the phase 3 HOPE study (NCT03036813), leg ulcers resolved within 24 weeks in 10 out of 14 patients, and leg ulcers improved or resolved in 13 out of 14 patients by week 72. Materials and methods: RESOLVE is an ongoing phase 3, randomized, double-blind, placebo-controlled, multicenter trial investigating the efficacy of voxelotor with standard of care (SOC) in the resolution of leg ulcers in patients with SCD. Target enrollment is 80 patients from Nigeria, Kenya, and Brazil with a confirmed diagnosis of SCD (HbSS or HbSβ0 genotype), aged ≥12 years, and with ≥1 cutaneous ulcer on the lower extremity (leg, ankle, or dorsum of foot) that meets the following criteria: ≥2 weeks’ and <6 months’ duration at screening and >2 cm2 in area before randomization. After a 2-week run-in period, participants are randomized 1:1 to receive once-daily oral voxelotor 1500 mg or placebo in addition to SOC for 12 weeks. After the randomized treatment period, all participants receive open-label voxelotor 1500 mg plus SOC for 12 weeks (Figure). Results: The primary objective of the study is to assess the efficacy of voxelotor plus SOC compared with placebo plus SOC on leg ulcer healing, measured by the proportion of patients with resolution of target ulcer(s) in each treatment group by week 12. Key secondary endpoints include days to resolution of target ulcer(s) up to week 12, change from baseline in total surface area of target ulcer(s) at week 12, and incidence of new ulcers by week 12. Conclusion: Results from this study will further guide clinicians and patients regarding the clinical use of voxelotor for the treatment of leg ulcers in patients with SCD. Participants will have the option to enroll in a separate open-label extension study after the 24-week treatment period.Figure. RESOLVE Study Design, Population, and Timeline J. DOSS declares a conflict of interest: Stock shareholder: Global Blood Therapeutics, Roche

Hydroxyurea and fetal hemoglobin effect on leg ulcers in patients with sickle cell disease.

The presence of leg ulcers in individuals with sickle cell disease often represents an early sign of vasculopathy and future end organ damage. Pathophysiological mechanisms of formation and evolution of leg ulcers are poorly understood; nevertheless, HbF has been associated with lower incidence of leg ulcers, while hydroxyurea has been correlated with high risk of leg ulcers. As a result, there is hesitation regarding hydroxyurea use in patients with SCD and leg ulcers. In this study, we aim to define (1) a target of HbF that offers protection against leg ulcer development and (2) the impact of hydroxyurea therapy on leg ulcer prevalence. Our study demonstrated that in order to reduce leg ulcer incidence by one-third, a HbF > 25% is needed, a threshold not commonly reached and maintained in the adult SCD population. Importantly, leg ulcer incidence appears to be independent of HU use (p = 0.50). Our interpretation of this data is that the use of HU in a patient with SCD and leg ulcers should be guided by a careful assessment of risks and benefits of this therapeutic modality.

Prevalence of leg ulcers in the province of Cuenca: A study in Primary Care

ObjectiveTo determine the prevalence of leg ulcers, and to describe the affected patients, wounds, and treatment. MethodObservational, cross-sectional prevalence study. An ad hoc online questionnaire was sent to all nurses attending Primary Care centres of the “Gerencia de Atención Integrada de Cuenca” (Integrated Care Management of Cuenca, Spain). Data regarding patient sociodemographic and clinical variables, lesion characteristics and the type of intervention (concerning prevention and treatment) were collected. ResultsIn total, 152 professionals (response rate = 98.1%) completed the questionnaire, collecting data from 131,190 inhabitants. A total of 63 patients (75.5 ± 12.6 years old) with 75 ulcers were identified, finding an overall prevalence of .480‰ (CI 95%: .375−.614), distributed as: venous ulcer .274‰ (n = 36), diabetic foot .145‰ (n = 19), and arterial ulcer .061‰ (n = 8).The prevalence was similar regarding gender (.535‰ vs .426‰, respectively, p = .365), but men exhibited more diabetic foot (.214‰ vs .076‰, p = .037).In all three types of lesions prevalence increased with age, reaching 1.743‰ in 64+ age group.The median of the leg ulcer duration and corrected area were 190.0 ± 340.0 days and 5.0 ± 13.7 cm2, respectively, with a recurrence rate of 74.7%. ConclusionsThe prevalence of chronic leg ulcers was lower than that reported in other studies, although with high recurrence rates. Overall estimators from previous studies may have overestimated the prevalence, especially in regions with a high rural component.

Clinico-epidemiological study of chronic leg ulcers in a tertiary care referral center from Tamil Nadu, India

&lt;p&gt;&lt;strong&gt;Background:&lt;/strong&gt; Leg ulcer is a common ailment of elderly presented with complex dermatological conditions. It may occur as a sequel to infection, malignancy, adverse drug reaction, trauma and hematological disorders. The paucity of data on the prevalence and outcome of the chronic leg ulcer in India served as a basis to conduct this clinico-epidemiological study. To study the prevalence of leg ulcers in a tertiary care referral hospital.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;In this cross-sectional study, 100 patients with leg ulcer attending the dermatology OPD at Madras medical college, Chennai, were enrolled after obtaining their consent. Detailed case history of each patient was recorded. Routine clinical investigations, Doppler study and culture were done to detect associated complications. In this study, 58 males and 42 females, with the mean age of 42.01±14.302 years, mean duration of leg ulcer of 17.79±29.87 months were recruited.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results:&lt;/strong&gt; Venous ulcer (37%) was the most prevalent type of leg ulcer recorded in our study. Doppler study revealed that the 31% of venous ulcers patients developed perforator incompetence. &lt;em&gt;Staphylococcus aureus&lt;/em&gt; was the major microbe isolated from the lesions (27%).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; Chronic leg ulcers are very common in elderly patients and venous ulcer being the most common. Doppler is an effective tool for the assessment of disease severity of venous ulcers and aided in offering the adequate management of the disease. Diagnosis of underlying causes such as pyoderma gangrenosum, autoimmune diseases, malignancies and bacterial culture from the wound will be helpful for the management of the disease.&lt;/p&gt;

Prevalence of leg ulcers in the province of Cuenca: a study in Primary Care.

To determine the prevalence of leg ulcers, and to describe the affected patients, wounds, and treatment. Observational, cross-sectional prevalence study. An ad hoc online questionnaire was sent to all nurses attending Primary Care centres of the "Gerencia de Atención Integrada de Cuenca" (Integrated Care Management of Cuenca, Spain). Data regarding patient sociodemographic and clinical variables, lesion characteristics and the type of intervention (concerning prevention and treatment) were collected. In total, 152 professionals (response rate=98.1%) completed the questionnaire, collecting data from 131,190 inhabitants. A total of 63 patients (75.5±12.6 years old) with 75 ulcers were identified, finding an overall prevalence of 0.480‰ (CI 95%: 0.375-0.614), distributed as: venous ulcer 0.274‰ (n=36), diabetic foot 0.145‰ (n=19), and arterial ulcer 0.061‰ (n=8). The prevalence was similar regarding gender (0.535‰ vs. 0.426‰, respectively, p=.365), but men exhibited more diabetic foot (0.214‰ vs. 0.076‰, p=.037). In all three types of lesions prevalence increased with age, reaching 1.743‰ in 64+age group. The median of the leg ulcer duration and corrected area were 190.0±340.0 days and 5.0±13.7cm2, respectively, with a recurrence rate of 74.7%. The prevalence of chronic leg ulcers was lower than that reported in other studies, although with high recurrence rates. Overall estimators from previous studies may have overestimated the prevalence, especially in regions with a high rural component.

Risk factors for leg ulceration in people who inject drugs: A cross‐sectional study

The aim of this study was to assess, for the first time in a hard-to-reach population, the risk factors for leg ulceration among PWID, with the objective of making improvements to prevention and care. An estimated 4.8 million people globally inject drugs with potential for injecting-related harm. Skin and vein damage associated with drug injecting is increasing. Leg ulceration is a chronic condition which in the UK has a prevalence of 15% among people who have injected drugs (PWID) compared with 1% in the general population. Glasgow has the highest rate of problematic drug use in Scotland with approximately 13,900 individuals, about 50% of whom are thought to inject. However, the reasons for high prevalence of leg ulceration among PWID are unknown. To support improvements in prevention and care, the dearth of evidence around risk factors for leg ulceration in PWID needs to be addressed. A cross-sectional survey of 200 current and former injectors recruited from drug services in Glasgow, Scotland, to measure skin problems, leg ulceration and injecting habits is reported following STROBE guidelines. Logistic regression modelling examined whether demographics and injecting habits predicted leg ulceration. The likelihood of leg ulceration was increased for those who injected in the groin and the leg. Additionally, injecting in the groin and leg were associated with having a DVT. The primary risk factors for leg ulceration in PWID are injecting in the groin and the legs and these are clinically linked to deep vein thrombosis. Injecting into the femoral vein is increasingly common practice for PWID and healthcare practitioners should advise injectors of the increased risk of leg ulceration and DVT and discourage injecting into these areas.

Prevalence and Predictive Factors for Leg Ulcers in Sickle Cell Disease Patients in Saudi Arabia: A Cross-Sectional Observational Study.

IntroductionSaudi Arabia has a high prevalence of sickle cell disease (SCD). Leg ulceration is one of the complications associated with SCD. There is a gap in the literature in regard to the prevalence of leg ulcers among SCD patients in Saudi Arabia.ObjectivesThe primary objective of this study was to evaluate the lifetime prevalence of leg ulcers in SCD patients in our population and to study the predictive factors of leg ulcers by using sociodemographic factors, clinical manifestations of SCD, and other relevant factors like hydroxyurea.MethodsA cross-sectional study design was utilized. Data collection was done using an electronic survey to collect self-reported information for the prevalence of leg ulcers and possible associated factors. The survey was distributed using social media platforms. Chi-square test was used to test for the presence of an association between having leg ulcers and sociodemographic variables as well as SCD related history. Furthermore, binary logistic regression was utilized to determine factors predicting the incidence of leg ulcers among SCD.ResultsA total of 790 valid responses were included in the study. Among these, 646 were included in the analysis of leg ulcers prevalence. From them, 52 (8%) SCD patients reported a history of leg ulcers. The male to female ratio was (9.7% vs 7.2%). The age group most affected by leg ulcers was those older than 50 (16.7%). There was no significant association between a history of leg ulcers and sociodemographic variables. The only predictive factors for leg ulcers were having six to eight vaso-occlusive crises per month and having more than eight vaso-occlusive crises per month.ConclusionLeg ulcers among SCD patients in Saudi Arabia were considerably prevalent (8%). There was no statistically significant correlation between leg ulceration and sociodemographic variables. Leg ulcers were more likely in patients with a history of highly frequent vaso-occlusive crises. No association was found between the incidence of leg ulcers and other complications of sickle cell disease or hydroxyurea.

A study of the geographic distribution and associated risk factors of leg ulcers within an international cohort of sickle cell disease patients: the CASiRe group analysis

Vasculopathy is a hallmark of sickle cell disease ultimately resulting in chronic end organ damage. Leg ulcer is one of its sequelae, occurring in ~ 5-10% of adult sickle cell patients. The majority of leg ulcer publications to date have emanated from single center cohort studies. As such, there are limited studies on the geographic distribution of leg ulcers and associated risk factors worldwide. The Consortium for the Advancement of Sickle Cell Research (CASiRe) was formed to improve the understanding of the different phenotypes of sickle cell disease patients living in different geographic locations around the world (USA, UK, Italy, Ghana). This cross-sectional cohort sub-study of 659 sickle cell patients aimed to determine the geographic distribution and risk factors associated with leg ulcers. The prevalence of leg ulcers was 10.3% and was associated with older age, SS genotype, male gender, and Ghanaian origin. In fact, the highest prevalence (18.6%) was observed in Ghana. Albuminuria, proteinuria, increased markers of hemolysis (lower hemoglobin, higher total bilirubin), lower oxygen saturation, and lower body mass index were also associated with leg ulceration. Overall, our study identified a predominance of leg ulcers within male hemoglobin SS patients living in sub-Saharan Africa with renal dysfunction and increased hemolysis.

Chronic leg ulcers in older patients

Chronic ulcers of the lower extremities are one of the most common medical problems encountered in western societies. The prevalence of leg ulcers is estimated to be 0.5-1.0% of the German population and is clearly associated with age. Therefore, in an aging society chronic leg ulcers are an important health issue with respect to increased morbidity and healthcare costs. The most frequent causes of leg ulcers are chronic venous insufficiency, peripheral arterial occlusive disease and diabetes mellitus. Efficient treatment necessitates an exact diagnosis and a close interdisciplinary collaboration. Affected patients often require instructions regarding self-help and support for competent nursing and prophylaxis. Therapeutic strategies, especially in the geriatric setting, aim to maintain the quality of life through preservation of patient mobility and autonomy.

A targeted interprofessional educational intervention to address therapeutic adherence of venous leg ulcer persons (TIEIVLU): study protocol for a randomized controlled trial

BackgroundVenous leg ulcers are slow-healing wounds with a high recurrence rate of 70% and a 60% risk of becoming chronic. Signs and symptoms such as pain or exudate are not only a burden on those affected but also on the healthcare system and society in general. The estimated leg ulcer prevalence in the general population is 1%. Treatment costs for leg ulcers are estimated to be 3% of overall health expenditure. Current therapeutic approaches are multifaceted and include compression therapy, leg elevation, specific ankle-exercises and a protein diet. They require an interdisciplinary team of health care professionals. Approximately 70% of patients have a knowledge deficit with regards to therapeutic measures and have difficulties with adherence to treatment protocols. Therefore, it is of utmost importance that the treatment team provides effective patient education and support during the learning phase. However, there is little evidence and no published studies that describe and evaluate effective interdisciplinary educational interventions that target compliance/adherence to the treatment plan in patients with leg ulcers. We therefore propose to develop an evidence-based interprofessional educational intervention and evaluate its feasibility first in a pilot study and subsequently in a randomized controlled trial.Method/DesignFirst, the development of an evidence-based educational intervention in collaboration with an expert panel is proposed and second, a randomized controlled feasibility study in a wound-care outpatient clinic. Eligible patients (n = 20) with leg ulcers will be randomized to receive either interdisciplinary education and usual care or only usual care, for 12 weeks. Data will be analyzed using SPSS version 25. Univariate and bivariate analysis will be conducted according to the data level and distribution of the data.DiscussionWe will first develop an evidenced-based educational intervention and second, we will examine the feasibility of implementing this educational intervention in a realistic care context in patients with leg ulcers. The results will inform the final design of a subsequent randomized controlled trial, which will examine the effectiveness of the educational intervention. An intervention that enhances patient adherence to therapy would be beneficial to individual patients and to society as a whole.Trial registrationClinicalTrials.gov, NCT03454698. Registered on 6 March 2018.

A Preliminary Study of Pain Relieving Dressings for Older Adults With Chronic Leg Ulcers From the Provider’s Perspective: A Qualitative Study

Prevalence of leg ulcers increases with age due to an increase in risk factors, including immobility and venous disease. With an increasingly aging population, therefore, the number of older adults with leg ulcers is increasing. Older adults with leg ulcers experience frequent pain and discomfort, and yet pain in this population is poorly managed. The aim of this study was to explore the feasibility of the use of analgesic dressings in older adults with leg ulcers, including their perception of current pain management, feasibility of an analgesic dressing, and potential challenges. The overriding objective was to use the information to design a novel advanced dressing that is highly effective and acceptable to patients and health professionals at affordable cost. Focus groups involving nurses, with experience of leg ulcers, were conducted. Participants were asked their opinion on pain from leg ulcers, including perception of current pain management, feasibility of an analgesic dressing, and potential challenges of using analgesia in this format. Focus groups and interviews were recorded and transcribed verbatim and analyzed using a framework approach. Fifteen nurses attended two focus groups and one older adult completed a telephone interview. The overall opinion of an analgesic dressing were very positive; the key themes relating to the use of an analgesic dressing in practice include duration of pain relief; when pain occurs; type of analgesic; skin integrity; training/experience; compliance; and dressing practicalities. Leg ulcers are well known to be painful and often associated with social stigma. A dressing that deals with absorption issues and can help to manage pain, particularly during dressing changes (when pain is highest), would be welcomed by nurse professionals. This preliminary study provides a basis upon which future research can be based.

A study to find the causes of diabetic foot infections in a selected community

Background: Ulcerations associated with diabetes are the most common cause of foot infections. Most of these ulcers are a direct result of loss of sensation secondary to peripheral neuropathy. The prevalence of leg ulceration is approximately 1% to 2%, and is slightly higher in the older adult population. Venous ulcers are the most common form of leg ulcers, accounting for almost 80% of all lower extremity ulcerations. Peak prevalence is between 60 and 80 years. Approximately one third of patients with chronic venous insufficiency will develop venous ulceration before the age of 40 years. In addition, venous ulcers may have a prolonged duration and are associated with a high rate of recurrence, which contributes to their prevalence. Approximately 15% of persons with diabetes will develop foot ulceration during their lifetime. Most lower extremity amputations in India are preceded by a foot ulcer. This study is done to find the commonest causes of foot infection in the background of neuropathy among the selected population.Methods: Total of 153 patients were included in this study. Detailed history was taken and all the wounds were classified according to Wagner’s grades. Foot infections in the grade 3,4, 5 (which required debridement/amputations) were included in the study. Foot ulcerations without infections were excluded from the study.Results: 142 (92%) of the patients with infection had diabetic neuropathy. All patients with diabetic neuropathy presented with sensory neuropathy. 33 (21%) patients presented with infection due to previous callus. 52 (33%) patients presented with infection due to previous non-healing ulcer. 20 (13%) patients with deformities developed callus at bony pressure areas due to neuropathy or post-surgery sequel. One patient had hot water burns injury. Five (0.03%) patients had Ingrown nails. 14 (0.09%) patients related to barefoot walking/thorn prick injuries. 6 (0.03%) patients had fungal infection. Two (0.01%) patients had itching and scratching over legs. 15 (0.09%) patients had history of previous amputation. Vigorous massage was the cause in 1 patient (0.006%). Shoe bite injury resulted in foot ulcer in 2 (0.02%) patients. Two (0.02%) patients presented with infection due to deep cracks in heels.Conclusions: Neuropathic changes is the most common cause of diabetic foot infections among which callus, non-healing trophic ulcer and previous amputee are the predominant causes. Patient education has a crucial role in prevention of diabetic foot infections by foot care precautions.

Socio-environmental exposures and health outcomes among persons with sickle cell disease.

There is much variability in the expression of sickle cell disease (SCD) and recent works suggest that environmental and social factors may also influence this variability. This paper aims to use geographic information systems technology to examine the association between socio-environmental exposures and health outcomes in all persons who have attended or currently attend the Sickle Cell Unit in Jamaica. Rural patients presented for clinical care at older ages and had less annual visits to clinic. Persons travelled relatively long distances to seek SCD care and those travelling longer had less health maintenance visits. Urban patients had a higher prevalence of significant pain crises (69.4% vs. 55.8%, p value<0.001) and respiratory events (21.2% vs. 14%, p value<0.001). Prevalence of leg ulcers did not vary between rural and urban patients but was higher in males than in females. Females also had lower odds of having respiratory events but there was no sex difference in history of painful crises. Persons with more severe genotypes lived in higher poverty and travelled longer for healthcare services. Persons in areas with higher annual rainfall, higher mean temperatures and living farther from factories had less painful crises and respiratory events. The paper highlights a need for better access to healthcare services for Jamaicans with SCD especially in rural areas of the island. It also reports interesting associations between environmental climatic exposures and health outcomes.

A study on newer dressing materials versus conventional dressing materials in ulcer healing

Background: The dressing of wounds is an old art and has undergone a wide variety of changes from ancient herbal dressing to modern dressing materials. The main aim was always to heal the wounds. Wounds and their management are fundamental in the practice of surgery. The prevalence of leg ulceration is approximately 1% to 2%, and is slightly higher in the older adult population. The main aim of the study was to compare the newer dressing materials versus the conventional dressing materials in terms of various factors responsible for wound healing. Methods: A total of one hundred patients admitted in surgery ward were allotted into two groups – conventional dressing materials (regime A) and newer dressing materials (regime B) on random basis. The patients were assessed on daily basis in both test and control groups with parameters like ulcer size, rate of granulation tissue formation, time required for removal of slough and rate of wound healing. Results: Out of 100 cases studied, maximum numbers of patients were in age group 51 to 60 years (23%). With use of Regime A we have noticed that healing stage in 1 patient was within 7 days, 8 patients between 8-14 days, 13 patients between 15-21 days and 28 patients between 22-30 days. With use of Regime B we have noticed healing stage in 4 patients was within 7 days, 13 patients between 8-14 days, 19 patients between 15-21 days and 14 patients between 22-30 days. Conclusions: As per study carried out we would conclude that newer dressing materials are more efficient as compared to conventional dressing materials in all stages of ulcer healing even though there is slight compromise in its availability.