Diabetic foot in persons with DM Typ 1 Diabetic foot in persons with DM Typ 2 E10.74
Conditions
Interventions
Group 1: Intervention group: Intelligent iFoot bandage integrating offloading with monitoring of pressure, humidity and temperature and communication of the results to the patients and their physician
Sponsors
Amb. Zentrum für Diabetologie, Endoskopie und Wundheilung Köln
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.) Type1 diabetes, type2 diabetes, or type3 diabetes between 18 years and 85 years of age. 2.) Polyneuropathy 3.) Pressure ulcer 3.1) Wound plantar, pressure related, bony prominence palpable under wound 3.2) Pressure ulcers on the heel dorsal 4.) ulcers stage 1 or 2 after Wagner or stage 3 after surgical rehabilitation
Exclusion criteria
Exclusion criteria: 1.) Active Charcot foot, 2.) Tumor less than 5 years in remission, 3.) Severe disease which reduces life expectancy less than 6 months 4.) Severe mental illness 5.) Ulcer stage 3 or higher according to Wagner without surgical rehabilitation 6.) Necrotic wound areas at the time of randomization 7.) PAD in need of revascularization 8.) Permanent accessibility of the patient is not guaranteed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time until the wound area is halved | — |
Secondary
| Measure | Time frame |
|---|---|
| Time until wound closure, number if intervisit-intervals with enlargement of wound area, Economiy, QoL | — |
Countries
Germany
Contacts
Public ContactDirk Hochlenert
Amb. Zentrum für Diabetologie, Endoskopie und Wundheilung Köln
Outcome results
None listed