DRKS00013798
Completed
未知
Intelligent sensor-equipped shoe insole for patients with diabetic neuropathy for prophylaxis of foot ulcers (ulcer) - ISS
Otto-von-Giericke University MagdeburgMedical Faculty0 sites286 target enrollmentJanuary 18, 2018
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- E11.74: Diabetes mellitus, type 2 With multiple complications With diabetic foot syndrome, not described as derailedE11.73: Diabetes mellitus, type 2 With multiple complications With other multiple complications, referred to as derailed
- Sponsor
- Otto-von-Giericke University MagdeburgMedical Faculty
- Enrollment
- 286
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diabetes mellitus type 1 or type 2
- •\- ages between 18 and 85 years
- •\- Sensomotoric peripheral diabetic polyneuropathy (sensation of vibration by means of a graduated tuning fork according to Rydel / Seiffer \- Missing neuropathic ulcers in the foot area in the anamnesis (risk group 2\) or healed neuropathic ulcers in the foot area in the anamnesis (risk group 3\)
- •\- Good general condition
- •\- capacity to consent
- •\- written consent after clarification
- •\- Dealing with mobile phone and app after instruction possible
Exclusion Criteria
- •\- Existing foot ulcers at the beginning of the clinical trial
- •\- Macroangiopathy of the lower extremities (ABI \<0\.5\)
- •\- Risk group 0\-1 according to the classification system for shoe care and risk assessment in diabetic foot syndrome \[9]
- •\- heart failure St. III / IV according to NYHA
- •\- Active tumor disease
- •\- Physical deformities (amputations, foot, leg, spinal deformities affecting the gait)
- •\- Visual impairment, so that the use of an app using a tablet can not be performed
- •\- Myocardial infarction before \= 12 weeks
- •\- pregnancy
- •\- Any other reason that, in the opinion of the investigator, precludes participation.
Outcomes
Primary Outcomes
Not specified
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