iFoot - Improving inter-facility care for people with diabetic foot syndrome (DFS) using eHealth. A prospective, multicentre, randomized trial.
Organizational Data
- DRKS-ID:
- DRKS00023094
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2021-02-05
- Last update in DRKS:
- 2021-10-25
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
Brief summary in lay language
Testing of an intelligent dressing for the treatment of diabetic foot syndrome.
Brief summary in scientific language
In the iFoot pilot study, a new type of care documentation is to be tested. For this purpose, a sensor technology was developed that measures physical variables such as pressure, temperature, and humidity of the wound environment. The iFoot sensor technology determines these variables and generates information for patient and practitioner. In this multi-center study, standard therapy will be tested against the same standard therapy with additional information provided to the patient and care team from the iFoot sensor technology. Sensor technology will be added to the dressing for each participant. The two groups differ in that the intervention group will have alerts played to the patient's smartwatch and the caring team will be informed if, for example, there is any evidence of adverse development such as overloading of the foot. In the second group, the same sensor data are also collected, but no alerts are played on the smartwatch. Blinding will be achieved by a blinded wound closure assessment committee. Two centers will enroll a total of 40 patients who will be followed up for up to 9 months. Randomization will be stratified by severity into two strata.
Health condition or problem studied
- ICD-10-GM (translation):
- E10.74
- ICD-10-GM (translation):
- E11.74
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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 physicians.
- Arm 2:
- Control group: Bandage integrating offloading with monitoring of pressure, humidity and temperature without communication of the results to the patients and their physicians.
Endpoints
- Primary outcome:
- Time until the wound area is halved
- Secondary outcome:
- Time until wound closure
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
- Other
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- Assessor
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
- Doctor's practice Köln
- Medical center Köln
Recruitment period and number of participants
- Planned study start date:
- 2021-02-08
- Actual study start date:
- 2021-02-22
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2021-10-18
- Target Sample Size:
- 40
- Final Sample Size:
- 20
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 85 Years
- Additional Inclusion Criteria:
- 1.) Type1 diabetes, type2 diabetes, or type3 diabetes between 18 years and 85 years of age.2.) Polyneuropathy3.) Pressure ulcer3.1) Wound plantar, pressure related, bony prominence palpable under wound3.2) Pressure ulcers on the heel dorsal4.) ulcers stage 1 or 2 after Wagner or stage 3 after surgical rehabilitation
Exclusion Criteria
1.) Active Charcot foot, 2.) Tumor less than 5 years in remission, 3.) Severe disease which reduces life expectancy less than 6 months4.) Severe mental illness5.) Ulcer stage 3 or higher according to Wagner without surgical rehabilitation6.) Necrotic wound areas at the time of randomization7.) PAD in need of revascularization8.) Permanent accessibility of the patient is not guaranteed
Addresses
Primary Sponsor
- Address:
Amb. Zentrum für Diabetologie, Endoskopie und Wundheilung Köln
Dr. Dirk Hochlenert
Merheimer Straße 217
50733 Köln
Germany
- Telephone:
- 02219731610
- Fax:
- 022113995369
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.cid-direct.de/aktuelles
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
Amb. Zentrum für Diabetologie, Endoskopie und Wundheilung Köln
Dr. Dirk Hochlenert
Merheimer Str. 217
50733 Köln
Germany
- Telephone:
- 0221 9731610
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
Amb. Zentrum für Diabetologie, Endoskopie und Wundheilung Köln
Dr. Dirk Hochlenert
Merheimer Str. 217
50733 Köln
Germany
- Telephone:
- 0221 9731610
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
Amb. Zentrum für Diabetologie, Endoskopie und Wundheilung Köln
Dr. Dirk Hochlenert
Merheimer Str. 217
50733 Köln
Germany
- Telephone:
- 0221 9731610
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
Projektträger ETN Technologiezentrum Jülich
Karl-Heinz-Beckurts-Str.13
52428 Jülich
Germany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
Ethikkommission der Ärztekammer Nordrhein
Tersteegenstr. 9
40474 Düsseldorf
Germany
- Telephone:
- +49-211-43021581
- Fax:
- +49-211-43021585
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-12-25
- Ethics committee number:
- 2020445
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-01-21
Further identification numbers
- Other WHO Primary Registry or Data Provider ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- This is a pilot study to test the sensor technology of the intelligent dressing. The data is solely for the purpose of further developing the iFoot.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publications/study results:
- No Entry
- Date of the first journal publication of results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry
