iFoot - Improving inter-facility care for people with diabetic foot syndrome (DFS) using eHealth. A prospective, multicentre, randomized trial.
- Conditions
- E10.74E11.74
- Registration Number
- DRKS00023094
- Lead Sponsor
- Amb. Zentrum für Diabetologie, Endoskopie und Wundheilung Köln
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time until the wound area is halved
- Secondary Outcome Measures
Name Time Method Time until wound closure<br>