Comparison of a removable offloading device and routine care to heal plantar ulcers due to leprosy and diabetes in the community

Phase 3

• Conditions: eprosy and diabetes mellitus; Not Applicable

• Registration Number: ISRCTN16519062
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-17
• Last Update Posted: 28 August 2023
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Aged 18 years old and above
2. With loss of sensation (inability to feel monofilament of 10 grams) and plantar ulcer in the foot due to leprosy or diabetes
3. Patients with multiple or bilateral ulcers will be included alongside those with just one ulcer

Exclusion Criteria

1. Multiple plantar ulcers where the largest ulcers cannot be offloaded effectively due to the presence of other ulcers
2. Sign of infection or infected ulcer or with the signs of sinus tracks
3. Insensitive feet along with orthopaedic conditions in the ankle, knee and hip or limb length discrepancy
4. Amputation; forefoot and above on the contralateral leg
5. Patients who are wheelchair dependent

Study & Design

• Study Type: Interventional
• Study Design: Not specified