Non-healing skin ulcers in patients with leprosy Skin and Connective Tissue Diseases Non-healing skin ulcers in patients with leprosy (Mycobacterium leprae infection)
Conditions
Interventions
Participants will be individually randomized at a ratio of 1:1 to one of two groups:
1. Platelet enriched plasma
2. Control
The patient enriched plasma intervention uses the patient’s own blood to
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chronic trophic ulcer on the feet or legs 2. Aged =18 years at the time of signing the informed consent 3. No blood-related abnormalities, haemoglobin (Hb) >9 g%, and Platelets >100 x10³ /µl 4. No other health-related complications and any other severe chronic illness (such as HIV, chronic Hepatitis B, chronic Hepatitis C, or TB patients under active treatment) 5. Ulcer surface area should be between 2 cm² and 20 cm² 6. Ulcer should be clean, dry and free from infection 7. Understands and voluntarily signs an informed consent document prior to any study-related assessments 8. Able to adhere to the study schedule and other protocol requirements
Exclusion criteria
Exclusion criteria: 1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participants from participating in the study 2. High blood pressure (>150 mmHg systolic) 3. Pregnant or breastfeeding 4. Erythema Nodosum Leprosum (ENL) or a leprosy reaction under steroid treatment 5. Any wound that has a clinical diagnosis of microbial infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For all outcome measures, healing is defined as the complete re-epithelialization of the index ulcer 1. Rate of healing based on two observations per week (cm² per unit time) measured from an independent assessment and software assessment (the ARANZ tool) of photographs where a clean ruler is placed at the level or the ulcer taken during dressing changes twice weekly between baseline and 70 days 2. Proportion healed at 42 days measured by from an independent assessment and software assessment (the ARANZ tool) of photographs at 42 days 3. Time to healing (days) measured by from an independent assessment and software assessment (the ARANZ tool) of photographs from baseline to 70 days, or until the ulcer is healed | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion healed at 70 days measured by from an independent assessment and software assessment (the ARANZ tool) of photographs at 70 days 2. Generic quality of life measured using a Nepalese version of the EuroQoL five-dimensional instrument (EQ-5D 3L) fortnightly between baseline and discharge and at 70 days 3. Long-term end-points measured at 6 months from randomization 3.1. Recurrence of same/different ulcer measured using investigator notes and the Follow up Clinical Record Form at 6 months 3.2. Anatomical changes in the limb measured using investigator notes and the Follow up Clinical Record Form at 6 months 3.3. Generic quality of life measured using a Nepalese version of the EuroQoL five-dimensional instrument (EQ-5D 3L) 4. Days hospitalized, both duration of initial admission and total, measured from patient notes at discharge and at 6 months 5. Health economic outcomes: 5.1. Number of visits to any healthcare facility from discharge to the end of follow-up assessed from patient notes at 6 months 5.2. Time taken to change dressings assessed from investigator notes during twice weekly dressing changes between baseline and discharge | — |
Countries
Nepal
Outcome results
None listed