Smart insole for patients with diabetic neuropathy for the prevention of foot ulcers
- Conditions
- E10E11Type 1 diabetes mellitusType 2 diabetes mellitus
- Registration Number
- DRKS00005683
- Lead Sponsor
- Otto-von-Guericke Universität, Medizinsiche Fakultät
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 64
Inclusion criteria for the healthy subjects:
- No macroangiopathy or skin defects of the lower extremities
- No polyneuropathy any etiology
- No diabetes mellitus
- No physical deformities (amputations, foot, leg, spinal deformities, etc.)
- No neuropathic ulceration in the foot
- No heart failure St. III / IV according to NYHA
- No myocardial infarction = 12 weeks ago
- Capacity to consent
- Written consent after being informed
Inclusion criteria for subjects with neuropathy:
- Diabetes mellitus type 1 or type 2
- Sensorimotor peripheral neuropathy (vibration perception by means of graduated tuning fork according to Rydel / Seiffer - Good general condition
- Absence of foot deformities requiring orthopedic shoes
- Absence of neuropathic ulcers or other wounds
- Absence of macroangiopathy of the lower extremities
Exclusion criteria for subjects with neuropathy:
- Neuropathic ulcers in the foot
- Macroangiopathy of the lower extremities
- St. heart failure III / IV according to NYHA
- Physical deformities (amputations, foot, leg, spinal deformities, etc.)
- Myocardial infarction = 12 weeks ago
- Lack of capacity to consent
- Lack of written consent after being informed
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Testing of the pressure and temperature sensors in an insole for recording the pressure and temperature correlation under pressure loading and depressuring
- Secondary Outcome Measures
Name Time Method