Comparison of removable off-loading device and routine care to heal plantar ulcer due to leprosy and diabetes in the community
Not Applicable
- Conditions
- Health Condition 1: A309- Leprosy, unspecified
- Registration Number
- CTRI/2023/12/060523
- Lead Sponsor
- Research department, TLM Community Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients aged 18 years and above with loss of sensation (inability to feel monofilament of 10 grams) and
2. 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
Patients with
1. Multiple plantar ulcers where largest ulcers cannot be offloaded effectively due to 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
- Primary Outcome Measures
Name Time Method 1. Adherence to removable walker boot <br/ ><br>2. User satisfaction <br/ ><br>3. Ulcer healingTimepoint: 1. Adherence to removable walker boot <br/ ><br>At the end of each week till 8 weeks, or at complete healing of ulcers. <br/ ><br>2. User satisfaction <br/ ><br>At the end of 8th week or at complete healing of ulcer, whichever is earlier. <br/ ><br>3. Ulcer healing <br/ ><br>At baseline, <br/ ><br>At the end of every 2nd week till 8 weeks or at completion healing of ulcer, whichever is earlier.
- Secondary Outcome Measures
Name Time Method 2. Ulcer healing rateTimepoint: 1. Ulcer healing rate <br/ ><br>At baseline, <br/ ><br>At the end of every 2nd week till 8 weeks or at completion healing of ulcer, whichever is earlier.