Sensory nerve transfer to restore loss of sensation in leprosy feet
| ISRCTN | ISRCTN27620882 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27620882 |
| Secondary identifying numbers | Protocol version 0.8, NIHR200132 |
- Submission date
- 14/03/2024
- Registration date
- 20/05/2024
- Last edited
- 09/06/2025
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
This particular protocol is concerned with nerve transfer surgery of leprosy neuropathic feet with loss of sensation for 5 years. It will take place in Anandaban Hospital, The Leprosy Mission Nepal in Kathmandu, Nepal. The study aims to implement the saphenous nerve (SN) to posterior tibial nerve (PTN) nerve transfer operation in Anandaban hospital and ensure that it has effects consistent with the literature on the restoration of the sensation at the plantar surface of feet. The study will also estimate the costs of the procedure and conduct a full health economic analysis to estimate the cost-utility of the intervention. The study is designed as a single-center, prospective interventional case series study and health economic analysis.
Who can participate?
Adult patients aged 18 years old and over with loss of sensation in the plantar surface of the feet due to leprosy neuropathy
What does the study involve?
Participants will receive a surgical procedure with transfer of the SN to the PTN followed by a decision analytic model. The main outcome is the restoration of the sensory function of the plantar region of the foot. Other outcomes include a quantification of resources used and the collection of cost information. The sample size will be 15 consenting participants who will be followed up at 3 and 6 months from enrolment.
What are the possible benefits and risks of participating?
The possible benefits for the participants will be the regain of lost sensation on the plantar surface of the foot. This regain of lost sensation will protect them from recurring ulcers which may have a positive impact on the overall quality of life.
This study involves surgery under local or general anesthesia. This may have some minor side effects on the participants. Additionally, there is some risk of localized infection at the site of incision
Where is the study run from?
Anandaban Hospital, Nepal
When is the study starting and how long is it expected to run for?
September 2023 to June 2025
Who is funding the study?
The Leprosy Mission Nepal
Who is the main contact?
Mr. Sushil Khatiwada (Finance Manager), Sushilk@tlmnepal.org
Contact information
Scientific, Principal Investigator
Anandaban Hospital, The Leprosy Mission Nepal
Lalitpur
P O Box 151, KTM
Nepal
 ORCID ID |
0000-0003-0622-880X |
|---|---|
| Phone | +9779851136027 |
| indran@tlmnepal.org |
Public
Anandaban Hospital, The Leprosy Mission Nepal
Lalitpur
P O Box 151, KTM
Nepal
| ORCID ID |
0000-0001-6234-4288 |
|---|---|
| Phone | +9779851176606 |
| dilips@tlmnepal.org |
Study information
| Study design | Single-center prospective interventional case series study and a health economic modelling study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Efficacy |
| Participant information sheet | 45179_PIS.pdf |
| Scientific title | Sensory nerve transfer to restore planter sensation in leprosy neuropathic feet - a pilot study and health economic analysis |
| Study objectives | The surgical transfer of the saphenous nerve to the posterior tibial nerve will help in regaining sensation at the plantar surface of the foot. |
| Ethics approval(s) |
Approved 09/08/2024, Nepal Health Research Council (Ramshah Path, Kathmandu, P.O.Box 7626, Nepal; +977 1 4254220; nhrc@nhrc.gov.np), ref: 219 (102_2024) |
| Health condition(s) or problem(s) studied | Patients with loss of sensation in the plantar surface of the feet due to leprosy neuropathy |
| Intervention | 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 limb to control bleeding. Two parallel incisions will be made, one anterior to the medial malleolus just over the saphenous vein and a second incision posterior to the medial malleolus over the tarsal tunnel. The length of each incision will be about 7-8 cm. After the skin incision anterior to the medial malleolus the saphenous nerve will be identified, which runs alongside the great saphenous vein. Two branches of the saphenous nerve (anterior and posterior) will be dissected and freed from the surrounding fascia for a length of 7 cm. At this level, both the branches contain 5–6 fascicles. The second skin incision will be made posterior to the medial malleolus where the posterior tibial nerve will be identified in the grove between the medial malleolus and the Achilles tendon after cutting the flexor retinaculum, it will be dissected for a length of about 5 cm. An epi-neural incision of the posterior tibial nerve will be made and 5-6 sensory fascicles will be identified using intra-operative electric stimulation. Those fascicles which did not evoke motor contractions of foot muscles will be considered sensory fascicles. These fascicles will be cut proximally and be re-routed towards the saphenous nerve. The saphenous nerve will be cut distally and joined (anastomosis) to the sensory fascicles of the posterior tibial nerve, using 8-0 nylon epi-neural repair. Then the skin wound will be closed and a below-knee plaster back slab will be applied for 3 weeks. The plaster back slab will be removed after 3 weeks, and the patient will be instructed to use footwear with microcellular rubber (MCR) insole while walking. The data collected will include information on basic demographics, clinical data including co-morbidity conditions, laboratory tests, x-ray, sensory assessment, ulcer information and size of ulcer (for patients with ulcers), quality of life and bone mass density, The post-operative sensory assessment will be done at 3 and 6 months in all three territories of the sole. Sensory recovery will be graded according to the MRC scoring system. Healing of ulcers (proportion of healed ulcers) in the feet will be also assessed for those who have ulcers in the feet. Bone density data will be collected at baseline and endline. Photographs of affected feet will be taken with a tablet at baseline, 3 and 6 months. Healing of ulcers will be confirmed by the local clinician based on his/her clinical judgement. To confirm an ulcer is healed, there should be complete epithelialization on the ulcer surface. The ulcer-related data will be collected for the participants who have foot ulcers only. Additionally, standardized ulcer pictures will be taken on the day of enrollment and then three and six months follow-up after enrollment. The pictures of the foot ulcers will be captured with the help of a built-in camera on a tablet (Samsung Galaxy Tab 6). The photograph will be captured perpendicular to the ulcer surface. For calibration purposes, a 3cm size clean paper ruler with the date and participant’s trial identification number will be placed in the photograph frame above or below the ulcer but at the level of the skin. The photographs will be sent to an independent assessor for measurement. The independent assessor will measure the ulcers with the help of PictZar Digital Planimetry Software (http://www.pictzar.com/). Estimating cost utility from a health service perspective: Treatment costs will be estimated. Net health service costs will be estimated by applying local reference costs. Potential savings from reduced hospital admissions and reduced healed cases in the community will be estimated from data on admission rates for people with ulcers and interventions with nurses or community health workers who serve people affected by leprosy. This method will be extended to include the costs of further complications as per the disease progression model above. These costs will be subtracted from the intervention costs to yield net costs (possibly yielding a negative quantity i.e. saving). Cost-utility will be constructed by dividing the cost by the DALY function, conducting a probabilistic sensitivity analysis (at least over the above distributions) and comparing the result to various reference willingness to pay thresholds in exemplar countries. Estimating cost utility from a Societal perspective: It could be argued that such a perspective is required only if the health perspective does not allow the intervention to dominate. However, the research team think it would be informative to model a wider perspective. These should include costs the person must bear to access treatment and lost productivity. The analysis will focus on the latter because costs to travel to the hospital are very variable across the world and are arguably not material when set against loss of earnings. To measure the effects on earnings, days lost from work will be estimated and then the contingent losses in earnings. National figures will be used to estimate the proportion of people in the labour market and the proportion of those who work in labour-intensive versus sedentary industries. It will be assumed (in a base case) that those in manual jobs do not work while they have an ulcer (since off-loading is essential to ulcer healing). National reference costs will be used to calculate the loss of earnings for manual workers over the mean duration of the healing phase of a plantar ulcer. A reference group will be created to ensure that the estimates are realistic and to suggest alternative quantities for illustrative deterministic sensitivity analyses. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 01/09/2023 |
| Completion date | 30/06/2025 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 15 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/09/2024 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- Nepal
Study participating centre
Lalitpur
P O Box 151, KTM
Nepal
Sponsor information
Hospital/treatment centre
Anandaban Hospital
Lalitpur
P O Box 151, KTM
Nepal
| Phone | +9779760814792 |
|---|---|
| info@tlmnepal.org | |
| Website | https://tlmnepal.org/ |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of the study will be reported to collaborators of this study. Equal credit will be given to those who have collaborated in the study. The findings will be shared with the patients and communities through the networks of The Leprosy Mission Nepal who have extensive experience in working with the patient communities. We shall also present our work at local and international conferences. Tools we will use to disseminate our research output include research reports in lay format; publication in peer-reviewed international journals; public announcements in LMICs; policy briefings; print and online media; institutional and social media accounts and websites. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request and approval from the Principal Investigator, Dr Indra Bahadur, indran@tlmnepal.org The data underlying the findings would require participant-level trial data to be made publicly available which could compromise patient privacy, and participants did not consent for their data to be made publicly available. We are however able to share non-identifiable participant-level data upon request with an appropriate data-sharing agreement in place. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 26/03/2024 | No | Yes |
Additional files
Editorial Notes
09/06/2025: The study was stopped. We couldn't find eligible study participants even after screening 370 participants.
15/10/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/10/2024 to 31/12/2024.
2. The overall end date was changed from 30/11/2024 to 30/06/2025.
3. The intention to publish date was changed from 01/02/2025 to 30/09/2025.
4. The plain English summary was updated to reflect these changes.
12/09/2024: Ethics approval provided.
12/08/2024: The recruitment start date was changed from 01/05/2024 to 01/09/2024.
26/03/2024: Study's existence confirmed by the Nepal Health Research Council (NHRC).
