Podoconiosis (non-filarial lymphedema) Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Lymphedema of at least one leg (cases) 2. Participants without lymphedema (controls) with or without chronic wounds of other origin (e.g. diabetes, injury) 3. Must have lived in an endemic area (West and North West Regions) for at least two (2) years 4. 15 years and above 5. Able and willing to give informed consent/ to provide assent to participate in the study
Exclusion criteria
Exclusion criteria: Any significant condition (including medical and psychological/ psychiatric disorder) which in the opinion of the study clinician might interfere with the conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of pathogens of medical significance associated with the onset of adenolymphangitis (ADL) attacks, measured in blood, skin swabs and wounds using next-generation sequencing (NGS) during an ADL attack in comparison to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Skin-microbiome composition will be analysed in podoconiosis lymphedema (LE) participants at baseline and during adenolymphangitis (ADL) attacks, and compared with baseline samples from participants in the control group using next-generation sequencing (16S/18S) and microbial culture analysis (API biochemical tests, MALDI-TOF, or Vitek 2 Compact). 2. Antimicrobial sensitivity in ADL causative bacteria and/or fungi are measured at baseline and during ADL attack using culture and sensitivity testing (disc-diffusion and/or Vitek AST cards). 3. Wound assessment in LE patients and their AMR profile are measured at baseline and during ADL attacks using NGS, culture and sensitivity testing (disk-diffusion and/or Vitek AST cards). Results will be compared with wounds of other origins (e.g., diabetic wounds/ulcers) examined at the same time points using the same methods. 4. Compare skin-microbiome profiles across LE stages using baseline and ADL samples analysed by NGS (16S/18S) and cultures. 5. Effects of non-communicable diseases (e.g., diabetes and hypertension) on LE changes will be examined at baseline and during ADL attack using the 5-point scale staging according to Tekola et al, 2008. Effects of NCDs on skin microbiome of LE patients at baseline and during ADL will be measured using NGS and cultures 6. Immune responses during ADL attack will be analysed from whole blood samples collected at baseline and ADL. Peripheral Blood Mononuclear Cells (PBMCs) and plasma will be prepared. In PBMCs, the immune cell populations (e.g., T cells and granulocytes) will be analysed using flow cytometry. Plasma will be used to analyse pro-inflammatory and Th1/Th2/Th17 immune responses and chemokines using Luminex and ELISA techniques. | — |
Countries
Cameroon