Leprosy and diabetes mellitus Other
Conditions
Interventions
The problem of plantar ulcers in leprosy and diabetes
Plantar ulcers are a serious complication in leprosy and diabetes globally resulting in hospitalization, disability, and amputation. About 26 mill
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence to the removable walker boot measured using pedometers, one is placed inside the walker boot and a second is placed on the patient’s wrist as a watch or in a pocket, to provide data on the number of steps taken by the patient during the assessment period which will be recorded weekly | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. User satisfaction with the off-loading devices measured using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) 2.0 at complete healing of ulcer or at 8 weeks from recruitment, whichever is earlier 2. Ulcer healing (complete epithelisation of ulcer) and the rate of healing measured by masked observers in another site using the Pressure Ulcer Scale for Healing (PUSH) tool. All observations will be based on a ‘blind’ assessment. The patient will be followed up for 8 weeks and photographs of ulcers will be taken at baseline and after every 2 weeks until the ulcer heals or at 8 weeks, whichever is earlier, to measure the ulcer area. The ulcer will be measured from the photographs taken using the data collection tablets. | — |
Countries
India, Nepal
Outcome results
None listed