E11.74: Diabetes mellitus, type 2 With multiple complications With diabetic foot syndrome, not described as derailed E11.73: Diabetes mellitus, type 2 With multiple complications With other multiple complications, referred to as derailed E11
Conditions
Interventions
Group 1: Experimental arm = 150 patients: Equipment of the intervention groups with "intelligent" insoles and smartphone app, 2x daily measurement (at least 5 min) of the foot temperatures, instructio
After the measurement, feedback is given to the patient as to whether the measurement was successful. If differences in temperature should be detectable study participants with the help of the mobile
This includes a regular self-inspection, pedicure, as well as the adherence to medical check-ups, on own responsibility by the patient, and serves the early detection of ulcerations. The daily measure
Sponsors
Otto-von-Giericke University Magdeburg
Medical Faculty
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion 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 </ = 4/8) - 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| a) safety information related to diabetes, the equipment (insole) • frequency of occurrence of AEs • Frequency of occurrence of SAEs b) Precursors of the primary endpoint • redness in the foot area • Infections in the foot area • Wounds in the foot area c) an effect of the occurrence of a preliminary stage or the primary endpoint on quality of life d) recording the adherence to the daily two-time temperature measurement based on data acquisition of the app, e) recording the frequency of the alert in the intervention group based on the data collection of the app, f) Detection of slow temperature drops as an indication of circulatory disorders (PAD) g) recording the adherence to the photo documentation | — |
Countries
Germany
Contacts
Public ContactIsabell Walter
Universitätsklinik für Nieren- und Hochdruckkrankheiten, Diabetologie und Endokrinologie
Outcome results
None listed