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"Smart insole for patients with diabetic neuropathy for the prevention of foot ulcers"

"Smart insole for patients with diabetic neuropathy for the prevention of foot ulcers" - Insole

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00005683
Enrollment
60
Registered
2014-01-27
Start date
2014-02-03
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

E10 E11

Interventions

Group 1: 30 patients with sensorimotor neuropathy: Alternating between standing (pressure load for 5, 10 and 20 min) and in between a relief when sitting (5 min each), duplication Group 2: 30 healthy

Sponsors

Otto-von-Guericke Universität, Medizinsiche Fakultät
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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 </ = 2/8) - 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

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Testing of the pressure and temperature sensors in an insole for recording the pressure and temperature correlation under pressure loading and depressuring

Countries

Germany

Contacts

Public ContactSilke Klose

Universitätsklinik für Nieren- und Hochdruckkrankheiten, Diabetologie und Endokrinologie

silke.klose@med.ovgu.de+49-391-67-13260

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026