The efficacy of topical adipose mesenchymal stem cell-conditioned medium versus framycetin gauze dressing in chronic plantar ulcer of leprosy: A randomized controlled trial.

Background Wound healing shows a unique interaction of several cells, growth factors and cytokines. The healing of chronic plantar ulcer of leprosy is influenced by various factors, one of which is the concentration of growth factors and cytokines related to the pathogenesis of impaired wound healing. Growth factors and cytokines can be found in the secretome of adipose mesenchymal stem cells. Aim To compare the effectiveness of topical adipose mesenchymal stem cell-conditioned medium and framycetin gauze dressing only on the healing of chronic plantar ulcer of leprosy. Methods In this randomised controlled trial, 32 patients with chronic plantar ulcer of leprosy were recruited. After detailed clinical and initial debridement, patients were randomised to two groups to receive either topical adipose mesenchymal stem cell-conditioned medium (n = 16) or framycetin gauze dressing only (n = 16) applied every three days for up to eight weeks, following which the ulcer size, adverse reactions and complications if any were monitored weekly. Results Healing percentage increased each week in all groups. Statistical differences between groups (P < 0.05) were observed from week 2 onwards for ulcer mean size reduction and from week 3 onwards for ulcer mean depth reduction. There were no adverse reactions or complications. Limitations Off-loading on subjects were not performed. Conclusion Adipose mesenchymal stem cell-conditioned medium is a potential therapeutic agent in the management of chronic plantar ulcer of leprosy.

Prevalence and risk factors for disability in leprosy patients in Indonesia during the post-elimination era.

Leprosy has been nationally eliminated in Indonesia, but it continues to be a public health problem, with disability contributing to the disease burden. Disability caused by leprosy often results in stigmatization, leading to decreased quality of life. This was a retrospective cross-sectional study using secondary data from primary healthcare centers in one of the districts in the region with the highest number of leprosy patients in Indonesia. All leprosy patients between 2016-2022 were included. Among 189 leprosy patients (mean age 46 years old, 65.6% male), 19% had grade 1 disability and 29.6% had grade 2 disability. Duration of disease, nerve enlargements, leprosy reactions, and symmetric lesions were identified as risk factors for both grade 1 and 2 disability. Being male and having a positive smear test was associated with a higher risk of only grade 2 disability. Disability due to leprosy is still prevalent in the post-elimination era despite the decline in new leprosy cases. Improvement in early case detection and prevention of disability are still needed in the post-elimination era.

The Stress of Leprosy as a Mediator of the Relationship Between Coping Resources, Coping Strategies, and Psychological Well-Being in Persons Affected by Leprosy. The Structural Equation Models Through a Correlation Study.

Intoduction: Psychological strength plays an important role in reducing stress due to leprosy because leprosy can cause physical, psychological, and social problems. For that reason, this study aims to investigate the relationship between coping sources, coping strategies, and psychological well-being through leprosy stress. Methods: This research instrument uses a stress perception scale, coping sources, coping strategies, and psychological well-being scale to collect data from 125 participants consisting of women (33.60%) and men 66.40%. The test analysis in this study uses SmartPLS through structural equation modeling to prove the correlation. Results: The results of the SEM test indicate that there is a negative relationship between coping resources and leprosy stress, with a coefficient value of (-0.380), p-value of (0.000) <0.05, and a positive relationship is obtained with psychological well-being with the coefficient value of (0.427), p-value of (0.000) <0.05. Meanwhile, the SEM test shows a negative relationship between coping strategies and stress of leprosy, with the coefficient of (-0.566), p-value of (0.000) <0.05, and a positive relationship is obtained with psychological well-being (0.355), p-value of (0.000) < 0.05. Furthermore, on psychological well-being, stress shows a negative relationship, with the coefficient of (-0.212), p-value of (0.002). Discussion: Exploration of important coping sources is done to weaken the power of leprosy as a stressor and the use of effective coping strategies is needed to solve physical, psychological, and social problems for "People Affected by Leprosy", and simultaneously these two attributes are used to achieve prosperity. psychological. better.

Understanding leprosy reactions and the impact on the lives of people affected: An exploration in two leprosy endemic countries.

BACKGROUND: Leprosy reactions, Type-1 and erythema nodosum leprosum, are immune-mediated complications of leprosy, which play a significant role in the morbidity associated with the disease. A considerable amount of literature has been published on the impact of leprosy in general but few studies focus specifically on leprosy reactions. This study aimed to investigate the impact of leprosy reactions on physical, psychological, and social aspects of the lives of people affected by analysing their life experiences and perspectives about leprosy reactions. METHODS/PRINCIPAL FINDINGS: This qualitative study involved people affected by leprosy reactions and their family members in two leprosy endemic countries. The data were collected through 66 interviews and 9 focus group discussions (4-6 participants each) in Surabaya, Indonesia, and Purulia, India. Content analysis and conversational analysis were performed. This study found that both types of leprosy reactions were perceived as an unpredictable and painful condition. Leprosy reactions restricted physical activities of the participants, such as going to bathroom, sleeping, eating, and cooking. In the interviews, the respondents expressed a range of emotions and feelings including confusion, sadness, anxiety, and anger. Some recounted that they felt stigmatized and lost opportunities to socialise and earn money. Differences between the two settings were identified. The majority of Indonesian participants preferred to stay at home, and some concealed the diagnosis of leprosy, while most of the Indian respondents continued working up to the time of hospitalization. CONCLUSION: Leprosy reactions are a distressing complication of leprosy and adversely affect the lives of those affected. Individuals reported physical discomfort, distress, anxiety, stigma, and financial hardship and these negative impacts in the physical, psychological, and social spheres reinforced each other. These findings provide important information about a need for early detection and sustained commitment to follow-up care for people with a history of leprosy reactions. More research on new drugs for reactional episodes, tools to measure knowledge, attitude, and practice, and costing study on leprosy reactions treatment are needed. We recommend the development and testing of holistic strategies to improve the management of leprosy reactions.

Pediatric Leprosy Profile in the Postelimination Era: A Study from Surabaya, Indonesia.

Children who live in leprosy-endemic areas are susceptible to infection due to early and frequent exposure to Mycobacterium leprae. Indonesia is on the verge of eliminating this disease (prevalence rate < 1/10,000 population), but pediatric leprosy continues to occur in low-endemic areas. This study aimed to evaluate pediatric leprosy over a decade in a tertiary hospital in Surabaya, Indonesia. A retrospective study of leprosy in children under 15 years old between 2010 and 2019 was conducted in the Morbus Hansen Division, Outpatient Clinic at Dr. Soetomo Hospital in Surabaya, Indonesia. Seventy pediatric leprosy cases were identified between 2010 and 2019, consisting of 58 multibacillary (MB)-type cases and 12 paucibacillary (PB)-type cases. Slit skin smear (SSS) was positive in 26 cases. There were two cases of grade-2 disability and 15 cases of leprosy reaction (erythema nodosum leprosum) in children at the time of diagnosis. There was an insignificant decline in the number of pediatric leprosy cases in the last 10 years. Cases and disabilities in children were found in some leprosy pocket areas even though the national elimination rate has been achieved. MB infections, disability, and treatment defaults were common problems in pediatric leprosy.

Characteristics of Grade 2 Disability in Indonesian Children with Leprosy: A Five-Year Multicenter Retrospective Study.

BACKGROUND: One of the indicators of achieved leprosy control is lower new cases of leprosy with grade 2 disability (G2D), while zero new pediatric case with G2D is one of the targets of The Global Leprosy Strategy. This study aimed to describe the characteristics of leprosy in children with G2D from seven provincial hospitals in Indonesia, spanning a period of five years. METHODS: This was a descriptive and retrospective study with cross-sectional design. Data were obtained from the medical records of leprosy-affected children in seven provincial hospitals in Indonesia between January 2014 and December 2019 using a total sampling method. Data obtained include characteristics of patients, clinical manifestations, and profile of leprosy in children with G2D. RESULTS: From the 132 data of childhood leprosy retrieved, male (58.33%), age group of 13-14 years (47.73%), and borderline tuberculoid leprosy (34.09%) comprised the majority of patients. Most of the patients had anesthetic macules as the initial manifestation. The results showed 20 (15.15%) children had G2D. Hands were the most common site affected (50.00%), manifested as claw hands, contractures, atrophy of thenar and hypothenar muscles, and pseudomutilation. Foot drop was seen in five (62.50%) children, and lagophthalmos was seen in one child with leprosy. CONCLUSION: This study shows that G2D is observed in 15.15% Indonesian children with leprosy at the time of diagnosis, which mostly occurs on the hands in the form of claw hands. Foot disabilities were also observed, most commonly as foot drop, while lagophthalmos was present with disabilities in the eyes. Disability due to leprosy in children really exists. The commitment of all health care services and related institutions is needed in order to reduce the incidence of disability due to leprosy in children.

A 5-year evaluation of chemoprophylactic treatment in elementary school children with subclinical leprosy.

Subclinical leprosy is an infectious disease in which the immune system remains infected with Mycobacterium leprae (M. leprae). The progress of subclinical leprosy to clinical cases within 1 year of infection is 1.5%, with an increase to 6% in the following 4 years. Rifampicin is frequently used for prevention of leprosy, and clarithromycin has a bactericidal effect on M. leprae. Thus, the combination of both is expected to improve disease control in patients with subclinical leprosy. The aim of the present study was to evaluate the efficacy of a chemoprophylactic treatment involving rifampicin and clarithromycin against subclinical leprosy in elementary school children from endemic areas of East Java over a 5-year period. The study was performed between 2011 and 2015. Samples were collected from 2,548 healthy elementary school children in Nguling (Pasuruan) and Raas (Sumenep), and analysed using ELISA for anti-PGL (phenolic glycolipid)-1 IgM antibodies. Children who were seropositive for anti-PGL-1 IgM antibodies received a chemoprophylactic regimen consisting of rifampicin (300 mg/day) and clarithromycin (250 mg/day) daily for the initial 10 days, followed by the same regimen every 2 weeks for 3 months. Clinical and serological evaluations were performed annually for 5 years. Amongst the 2,548 healthy elementary school children, 200 were seropositive. The anti-PGL-1 IgM antibody levels significantly decreased between 2011 and 2015 in Nguling (from 1,066.7 to 137.4 U/ml) and Raas (from 773.1 to 563.4 U/ml), the levels decreased every year. In addition, the proportion of patients with decreased anti-PGL-1 IgM antibody levels was consistently higher than patients with increased anti-PGL-1 IgM antibody levels in all periods, except during 2013-2014, in Nguling and Raas. Chemoprophylactic treatment involving rifampicin and clarithromycin may thus be effective against subclinical leprosy amongst elementary school children.

An assessment of the reported impact of the COVID-19 pandemic on leprosy services using an online survey of practitioners in leprosy referral centres.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has led to governments implementing a variety of public health measures to control transmission and has affected health services. Leprosy is a communicable neglected tropical disease caused by Mycobacterium leprae and is an important health problem in low- and middle-income countries. The natural history of leprosy means that affected individuals need long-term follow-up. The measures recommended to reduce transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can create barriers to health services. We evaluated the impact of the COVID-19 epidemic response on leprosy services and disease management. METHODS: We conducted a cross-sectional online survey with healthcare professionals in leprosy referral centres. RESULTS: Eighty percent of leprosy diagnostic services were reduced. All respondents reported that multidrug therapy (MDT) was available but two reported a reduced stock. Clinicians used alternative strategies such as telephone consultations to maintain contact with patients. However, patients were not able to travel to the referral centres. DISCUSSION: This study highlights the effects of the initial phase of the SARS-CoV-2 pandemic on leprosy services in a range of leprosy-endemic countries. Many services remained open, providing leprosy diagnosis, MDT and leprosy reaction medications. Centres developed innovative measures to counter the negative impacts of the COVID-19 pandemic.

Methotrexate and prednisolone study in erythema nodosum leprosum (MaPs in ENL) protocol: a double-blind randomised clinical trial.

INTRODUCTION: Erythema nodosum leprosum (ENL) is an immunological complication of leprosy. ENL results in morbidity and disability and if it is not treated can lead to death. The current treatment consists of thalidomide or high doses of oral corticosteroids for prolonged periods. Thalidomide is not available in many leprosy endemic countries. The use of corticosteroids is associated with morbidity and mortality. Identifying treatment regimens that reduce the use of corticosteroids in ENL is essential. Methotrexate (MTX) is used to treat many inflammatory diseases and has been used successfully to treat patients with ENL not controlled by other drugs, including prednisolone and thalidomide. We present the protocol of the 'MTX and prednisolone study in ENL' (MaPs in ENL) a randomised controlled trial (RCT) designed to test the efficacy of MTX in the management of ENL. METHODS AND ANALYSIS: MaPs in ENL is an international multicentre RCT, which will be conducted in leprosy referral centres in Bangladesh, Brazil, Ethiopia, India, Indonesia and Nepal. Patients diagnosed with ENL who consent to participate will be randomly allocated to receive 48 weeks of weekly oral MTX plus 20 weeks of prednisolone or 48 weeks of placebo plus 20 weeks of prednisolone. Participants will be stratified by type of ENL into those with acute ENL and those with chronic and recurrent ENL. The primary objective is to determine whether MTX reduces the requirement for additional prednisolone. Patients' reported outcome measures will be used to assess the efficacy of MTX. Participants will be closely monitored for adverse events. ETHICS AND DISSEMINATION: Results will be submitted for publication in peer-reviewed journals. Ethical approval was obtained from the Observational/Interventions Research Ethics Committee of the London School of Hygiene & Tropical Medicine (15762); The Leprosy Mission International Bangladesh Institutional Research Board (in process); AHRI-ALERT Ethical Review Committee, Ethiopia; Ethics Committee of the Managing Committee of the Bombay Leprosy Project; and The Leprosy Mission Trust India Ethics Committee; the Nepal Health and Research Council and Health Research Ethics Committee Dr. Soetomo, Indonesia. This study is registered at www.clinicaltrials.gov. This is the first RCT of MTX for ENL and will contribute to the evidence for the management of ENL.Trial registration numberNCT 03775460.