Projects
- Research priorities: Disability
- Country: India
- Budget: €118,674 | Project number: FP23.18
- Duration: April 2023 - September 2024
- Status: Ongoing
This study will address the following question: Can a low-cost technology for measuring baropodometry, undertaken at the community / primary care levels, help design personalized MCR footwear that reduces the risk of new ulcers among people affected by leprosy with a history of plantar ulcers?
Personalised footwear for foot ulcers in leprosy by baropodometry through an innovative community engagement model
Project coordination
Partners
- Sivananda Rehabilitation Home
- Damien Foundation India Trust
- Association of People Affected by Leprosy (APAL)
- Office of Additional District Medical Health Officer
- LEPRA
Project summary
Foot ulcers prevent people from walking and carrying out their daily duties, which impacts their income and well-being. If left untreated they can lead to permanent disability. Foot ulcers/wounds are common complications of leprosy. Their occurrence must be prevented to reduce the burden of disabilities among these individuals. Ulcers develop at points of high repetitive pressure on people’s feet, for example when walking. This is especially problematic for people affected by leprosy who have lost sensation in their feet.
A simple method of measuring foot pressure points involves the patient walking over a piece of paper after applying ink to their feet. This is known as using a Harris mat and is suitable for use in low-resource community settings. Footprints that are recorded using a Harris mat can then be visually enhanced on a computer using the software. The research group proposes to trial the use of these visualisations to produce special footwear for people affected by leprosy that will be tailor-made to reduce their pressure points and prevent ulcers.
People affected by leprosy will be involved in recording their footprints using Harris mats in their communities. Their footprints will then be sent to their local clinic, where customised footwear will be developed for each individual, in accordance with the specific measurements and pressure points of their feet.
The project aims to assess the benefits of this approach by recording the number and duration of ulcers that people affected by leprosy experience. The experiences of two groups of affected people will be compared over a 12-month period – one group will receive shoes that have been custom-made using the enhanced Harris mat visualisations of their footprints and pressure points; the second group will receive shoes that have been custom-made according to standard measuring procedures.
- Grant: LRI Regular Grant
- Research priorities: Diagnostic tests
- Country: Colombia
- Budget: €309,630 | Project number: FP23.17
- Duration: February 2023 - January 2027
- Status: Ongoing
This study aims to determine, in Colombian population, whether differential transcriptomic expression of Hes-1 gene (skin) and RISK4LEP gene signature (blood) areas present in newly diagnosed leprosy patients (mainly PB) as compared to healthy controls without known contact with leprosy patients.
Evaluation of five transcriptomic biomarkers for leprosy in a Colombian population.
Project coordination
Partners
Project summary
Leprosy is an ancient infectious disease caused by Mycobacterium leprae and Mycobacterium lepromatosis. Furthermore, these mycobacteria are responsible for 250.000 new cases of this disease worldwide, and in countries such as Colombia are reported around 400 cases each year. However, leprosy continues being endemic in more than 89 municipalities of this country; the research group considers that the detection of leprosy cases in Colombia could be the tip of the iceberg of the possible cases of leprosy. Given that, more than 70% of leprosy diagnoses are multibacillary with some degree of disability. These findings show the failures of the leprosy control programs to be early detection of this disease. In addition, the research group's previous studies have shown that a group of genes such as RISK4LEP and Hes-1 could be useful to promote the detection of this disease mainly in household contacts of leprosy patients and in skin symptomatic patients. Early detection of leprosy is key to reducing the disability, improving the quality of life of leprosy patients, and cutting the transmission chain of these mycobacteria. For this reason, the objective of this research is to determinate if there are changes of Hes-1 and RISK4LEP in leprosy patients and their household contacts in Colombian population.
In this study, skin scrapping and blood samples will be collected from 120 leprosy patients newly diagnosed or under treatment. Besides, in 1000 household contacts. Furthermore, in cases of skin lesions in household contacts, scrapping of skin for Hes-1 will be taken. Finally, the expected outcome for this study is to evaluate the expression of these group of genes that in a medium-term could be used to the leprosy detection.
- Research priorities: Diagnostic tests
- Country: Bangladesh
- Budget: €60,000 | Project number: FP23.16
- Duration: April 2023 - September 2024
- Status: Ongoing
This study will address the following question: What are the diagnostic/clinical sensitivity and specificity of ML-RPA assay toward detection of leprosy using a mobile suitcase laboratory platform?
Evaluation of Mycobacterium leprae specific RPA assay incorporated in mobile suitcase lab for rapid diagnosis of clinical and sub-clinical leprosy in Bangladesh
Project coordination
Partners
- Damien Foundation, Bangladesh
- University of Leipzig
- Kumasi centre for Collaborative Research in Tropical Medicine
- Dept. of Pharmacology, Institute of Post Graduate Medical Education and Research, India
- Bankura Sammilani Medical College And Hospital
Project summary
Leprosy is a debilitating and contagious disease, caused by an obligate intracellular bacterium Mycobacterium leprae (M. leprae) and is the leading cause of disabilities and deformities among all the communicable diseases. The global leprosy elimination target has been achieved in 2000, however, the transmission of this primeval disease still continues and annually 220,000-250,000 cases are detected in 127 affected countries. Deformities, along with low literacy level of the leprosy afflicted population also give rises to the perpetual social stigma toward the affected persons in the community. Therefore, leprosy remains a major incapacitating disease contributing to significant disability-adjusted life years and social stigma resulting in adverse psycho-social apprehension, even in this modern era.
Early diagnosis is crucial for effective treatment of leprosy cases and to protect the family members/ household contacts of the leprosy patients, who are most susceptible to getting the infection. Therefore, a rapid and confirmatory diagnostic method is crucial for accurate diagnosis of M.Leprae for early management of the patients and limiting the spread of the disease in the community. To address this problem, the research team intends to introduce an isothermal amplification assay- the “Recombinant polymerase amplification assay” in a suitcase lab that is simple, easy to perform, field-friendly, and a cost-effective molecular diagnostic system. The aims of the study are as follows :
1. Develop a test that can accurately detect leprosy patients.
2. Evaluate the test to correctly identify M.Leprae infected patients with visible signs and symptoms.
3. Evaluate the test in the household contacts of leprosy patients who are infected but have not developed the signs and symptoms yet, who are most at risk of developing the disease.
The research group has already developed the ML-RPA test which has shown to be highly accurate with cultured DNA from M.leprae in the laboratory. However, its efficacy to diagnose actual leprosy cases and their contacts remains unknown. Therefore, in this study, it is planned to investigate the diagnostic efficacy of the test in Bangladesh with actual leprosy cases and their household contacts. Samples from leprosy-affected individuals and their household contacts will be taken and tested with ML-RPA assay as well as real-time PCR (another molecular test with high accuracy in detecting leprosy). Results between tests will be compared to decide if the developed ML-RPA assay retains similar efficacy as the real-time PCR. If it proves to be similar to or even better than the real-time PCR, it will be recommended to apply the assay for diagnosis of the leprosy patients in the field, where the patients require the service most.
Co-financer: Turing Foundation
- Research priorities: Operational research
- Country: Bangladesh
- Project no.: FP23.13
- Budget: €47,680
- Duration: January 2023 - December 2023
- Status: Completed
The primary objective of thie study is to analyse the data over a 5-year follow-up period to compare the incidence of leprosy in the three cohorts, and to perform in-depth statistical analysis taking cluster effects into account.
Leprosy incidence, clustering and risk factors: Evidence from 5-year follow-up trial Maltalep and Ideal study in Bangladesh.
Project coordination
Project summary
Leprosy remains a public health problem in many countries. Leprosy occurs frequently among close contacts of affected persons. The pre-dominant mode of transmission of M. leprae is through the air (inhalation). The Maltalep trial in Bangladesh assessed the extent to which single dose rifampicin (SDR) suppresses excess leprosy cases among contacts in the year after BCG vaccination. At two years follow-up, there was no convincing effect of SDR. In this study the researchers aim to assess the results of the trial at 5 years follow-up. The proportions of new leprosy cases will be compared between two intervention arms (BCG vaccine with and without SDR) and in this study also include the 5-year follow-up of a non-intervention cohort that was followed simultaneously with the Maltalep trial. The results may inform the development of improved policies towards the elimination of leprosy in Bangladesh and countries with similar settings.
Co-financer: Turing Foundation
- Research priorities: Operational research
- Country: France
- Project no.: FP23.11
- Budget: €60,000
- Duration: July 2023 - June 2025
- Status: Ongoing
This study aims to conduct an international study involving laboratories participating in the leprosy diagnosis all over the world aiming at sharing a pilot external quality assessment (EQA) scheme for microbial diagnosis of leprosy and drug susceptibility testing (DST).
Setting an external quality assessment (EQA) programme for enhancing capacity building focusing to the microbiological tools used in the diagnosis of leprosy and the detection of drug resistance
Project coordination
- French National reference center for mycobacteria
Project summary
Diagnosis of leprosy needs to be improved in many places of the world since transmission is ongoing with new child cases every year and there are no sharp decrease in the new cases and incidence. Although clinical signs and examination of the patient are often sufficient to diagnose a new case, microbiological diagnosis is helpful for cases difficult to diagnose or to treat, especially in relapse cases, and in areas where expertise in leprosy is deficient. In addition, detection and surveillance of resistance to antileprosy drugs is now mandatory for all endemic countries for retreated cases as well as a part of new cases.
Research questions: Microbial diagnosis of leprosy and molecular detection of resistance to antileprosy drugs is done using analysis tools such as microscopy, detection of Mycobacterium leprae DNA, detection of mutations conferring resistance. These microbiological tools are implemented in many endemic regions, but they are mostly following in house protocols (no commercially available kits in most places), they are rarely standardised and never evaluated for their reliability. This project will organise a pilot external quality assessment (EQA) to compare results of leprosy labs when performed of identical samples.
Plan of investigation: The research group's lab, which is one of the supranational reference labs for surveillance of drug resistance, will prepare some tissue samples containing (positive samples) or not (negative samples) M. leprae. Since this bacteria cannot multiply in vitro, and because human skin biopsies will not be used, the researchers will take samples of animals infected with M. leprae, the classical one being the mouse model where M. leprae grows in their footpads. These samples will be shipped to diagnostics labs located in leprosy endemic regions and who are involved with routine leprosy diagnosis. These labs will also, in return, send to the research group's lab some (randomly chosen) of the skin samples they received from leprosy cases in their area for diagnosis purposes. The researchers will compare all the results obtained by the laboratories on the same sample: those with more than 80% of concordant test results will get a EQA certificate; those with under 80% concordance will be invited for a second EQA round and workshop meetings in order to improve their technical skills and succeed on the second EQA year. All the samples studied from the endemic regions labs will be used to draw a map of diagnosis capacity and drug resistance rates certified by microbiological laboratories. This will help the managers and the authorities to involve these labs in the projects on elimination of leprosy and surveillance of resistance to antileprosy drugs.