Intelligent sensor-equipped shoe insole for patients with diabetic neuropathy for prophylaxis of foot ulcers (ulcer)
- Conditions
- E11Type 2 diabetes mellitusE11.74: 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
- Registration Number
- DRKS00013798
- Lead Sponsor
- Otto-von-Giericke University MagdeburgMedical Faculty
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 286
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
- 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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acquisition of foot ulcerations at any time during a 24-month intervention with a smart shoe insole compared to a non-intervention group without information through a smart shoe insole. The number and time to reach the endpoint are the primary targets. If such an endpoint is reached, the severity level is classified according to the Wagner-Armstrong classification. For the study participants, the exam concludes on reaching the primary endpoint or after the 24 months have elapsed.
- Secondary Outcome Measures
Name Time Method a) safety information related to diabetes,<br>the equipment (insole)<br>• frequency of occurrence of AEs<br>• Frequency of occurrence of SAEs<br>b) Precursors of the primary endpoint<br>• redness in the foot area<br>• Infections in the foot area<br>• Wounds in the foot area<br>c) an effect of the occurrence of a preliminary stage or<br>the primary endpoint on quality of life<br>d) recording the adherence to the daily two-time temperature measurement based on data acquisition of the app,<br>e) recording the frequency of the alert in the intervention group based on the data collection of the app,<br>f) Detection of slow temperature drops as an indication of circulatory disorders (PAD)<br>g) recording the adherence to the photo documentation