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Comparison of removable device with non-removable plaster cast to relieve body weight on foot for healing of ulcers in leprosy

Removable off-loading devices versus total contact cast to promote healing of plantar ulcer in Leprosy: a non-inferiority, randomized control trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043568
Enrollment
150
Registered
2022-06-29
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A309- Leprosy, unspecified

Interventions

Intervention1: Removable walker: The removable walker will be fitted with the insole with pre-cut (excavated under wound area) for off-loading the ulcer area which will be determined by the physiother

Sponsors

The Leprosy Mission Trust India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with loss of sensation in the foot due to leprosy with non-complicated ulcer on the plantar surface of the foot suitable for total contact cast as determined by the treating physician 2. Patients aged 18 years and above

Exclusion criteria

Exclusion criteria: Patients with 1. ulcers on bilateral feet 2. ulcer on non-plantar area of the foot 3. multiple plantar ulcers 4. sign of infection or infected ulcer or with the signs of sinus tracks 5. history of diabetes / insensitive feet due to diabetes 6. vascular compromise to the foot 7. insensitive feet along with orthopaedic conditions in the ankle, knee and hip or limb length discrepancy 8. foot drop and/or post foot drop correction 9. amputation; forefoot and above 10. patients who are wheelchair dependent

Design outcomes

Primary

MeasureTime frame
The primary outcome will be 1. percentage of ulcers healed completely at 6 weeks 2. The proportion of healing area and time to healing in days All the primary outcomes will be photographed before and after the intervention and verified by the two independent assessors.Timepoint: Baseline, At 6 weeks from recruitment or complete healing of ulcer, whichever is earlier At 6 months from the recruitment.

Secondary

MeasureTime frame
1. Functional independence level 2. User satisfaction with off-loading devices 3. Quality of lifeTimepoint: Baseline, At 6 weeks from recruitment or complete healing of ulcer, whichever is earlier At 6 months from the recruitment.

Countries

India

Contacts

Public ContactDr Joydeepa Darlong

The Leprosy Mission Trust India

karthikot@hotmail.com9935284315

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026