Patients with loss of sensation in the plantar surface of the feet due to leprosy neuropathy Nervous System Diseases
Conditions
Interventions
This study investigates the surgical transfer of the saphenous nerve to the tibialis posterior at ankle level. The surgery will be under spinal or general anesthesia with a tourniquet at the affected
Sponsors
The Leprosy Mission Nepal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with loss of sensation of the foot (inability to feel monofilament of 10 grams) for a duration of more than one but less than five years 2. Patient with or without planter ulcers. Only non-infected ulcers will be included 3. =18 years of age 4. Patient who can provide informed consent 5. Completed multi-drug therapy (MDT) treatment
Exclusion criteria
Exclusion criteria: 1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participants from participating in the study (e.g. HIV, chronic Hep B, chronic Hep C or TB patients under active treatment) 2. Pregnancy or breastfeeding 3. Patients with Erythema Nodosum Leprosum (ENL) or a leprosy reaction under steroid treatment 4. Any wound that has clinical signs of infection 5. Nerve conduction test velocity less than 40 ± 3.4 m/s and amplitude of 9 mV in saphenous nerve 6. Other conditions in the ankle/foot like the acute stage of Charcot's foot, complicated ulcers with Osteomyelitis, and acute neuritis with positive Tinel’s sign (tender swollen peripheral nerve)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restoration of the sensory function of the plantar surface of the foot measured using the MRC scoring system at baseline and 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of ulcers healed measured by the local clinician based on his/her clinical judgement and photographs sent to an independent assessor for measurement at baseline, 3 and 6 months 2. Economic cost analysis from a health service perspective and wider societal perspective measured using data collected in medical records after six months of follow-up. | — |
Countries
Nepal
Contacts
Public ContactDilip Shrestha
Outcome results
None listed