The prevalence of impairments and limitations in activities and participation of leprosy patients in the Netherlands, and the evaluation of biomechanical risk factors for foot ulceration in leprosy patients with peripheral neuropathy.

The prevalence of impairments and limitations in activities and participation of leprosy patients in the Netherlands, and the evaluation of biomechanical risk factors for foot ulceration in leprosy patients with peripheral neuropathy. - Biomechanical risk factors for foot ulceration in leprosy patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30197

Enrollment

300

Registered

2006-08-30

Start date

2006-09-01

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

Hansen's disease Leprosy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Diagnosis of Leprosy 2) Having attended the Tropical Dermatology outpatient Clinic at the AMC within the last 15 years 3) Age >18 yrs;Additional in criteria for detailed foot analysis Inclusion criteria: 1) Peripheral neuropathy (for patients attending for detailed foot analysis)

Exclusion criteria

Exclusion criteria: 1. Diabetes mellitus 2. Co-morbid disease with significant limited walking ability, including COPD, significant cardiovascular disease, vaso-occlusive diseases, hemiplegia, arthroplasty and sciatica 3. Osteomyelitis or infection of the neuropathic foot (ulcer) 4. Acute neuro-osteoarthropathy 5. Inability to walk (walking aids are permitted as long as foot pressure measurements can be assessed)

Design outcomes

Primary

Measure	Time frame
First part of the study: Survey 1. Impairments questionnaire 2. Impact on participation and autonomy questionnaire (IPA) 3. WHO-DAS II (impairments) Second part of the study: subgroup analysis 1. Walking capacity (6 minute walking test) 2. Barefoot plantar footpressure 3. History of foot ulceration	—

Secondary

Measure	Time frame
Second part of the study: subgroup analysis 1. Clinical assessment to confirm neuropathic foot and inclusion/exclusion criteria 2. Demographics 3. CIRS questionnaire (co morbidity) 4. Foot examinatin (mobility, deformities) 5. In-shoe plantar pressure 6. 7 day walking activity 7. Footwear use	—

Countries

Netherlands

Outcome results