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Huidtemperatuur metingen bij de diabetische voet. Een observatie onderzoek naar de veranderingen van huidtemperatuur gedurende de dag


- candidate number22065
- NTR NumberNTR5209
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-mei-2015
- Secondary IDs53105 ABR
- Public TitleHuidtemperatuur metingen bij de diabetische voet. Een observatie onderzoek naar de veranderingen van huidtemperatuur gedurende de dag
- Scientific TitleSkin temperature monitoring of the diabetic foot: An observational study examining daily skin temperature changes of the foot
- ACRONYMskin temperature changes in the diabetic foot
- hypothesisFor the prevention of diabetic foot ulceration, evidence exists to support the use of home-monitoring of foot skin temperature by means of a hand-held infrared skin thermometer. However, the construct validity of skin temperature measurements is unknown. Factors such as time of day, activity, body temperature and environmental temperature may influence skin temperature changes and could lead to false positive or false negative results if applied as home-monitoring instrument. Increased knowledge is important for the optimization of the measurement procedure and for using temperature measurements as a home screening tooi by patients with diabetes. This pilot study intends to describe the skin temperature changes of the foot in patients with diabetes during the day. The secondary objectives are to describe the relationship with ambulatory activity, body temperature, and environmental temperature.
- Healt Condition(s) or Problem(s) studiedDiabetic ischemic ulcers, Self-monitoring, Temperature
- Inclusion criteria- Type 1 or 2 diabetes
- Simms' classification 1 or 2
- No ulcer on the feet or legs
- No major amputation
- Aged 18 years or older
- Body temperature below 38C
- No clinical signs of foot Infection.
- Able to use the thermometer and equipment
- Exclusion criteriaCritical ischemia, defined as an ankle brachial index < 0.6 or toe pressure < 30 mmHg
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 1-mei-2015
- planned closingdate31-dec-2015
- Target number of participants20
- InterventionsThis pilot study intends to describe the skin temperature changes of the foot in twenty patients with diabetes during the day. The aim of the study is to gain knowledge about skintemperature changes of the feet during the day. Therefore the skintemperature is observed during dailly activities without an intervention.
- Primary outcomeTo investigate changes during the day of the difference in skin temperature between the six contralateral spots in the feet of people with diabetes
- Secondary outcomeActivity, body temperature and environmental temperature
- TimepointsParticipants will be asked to measure the temperature of both feet, bodytemperature, environmental temperature and activity four times a day for the period of six days; the first time just after the participant wakes up, the second time between 11.00 and 13.00, the third time between 17.00-19.00 and the final time just before the participant goes to sleep. Data are to be recored in a diary.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES A.M. Wijlens
- CONTACT for SCIENTIFIC QUERIESDr. J. Netten, van
- Sponsor/Initiator Dr. J.J. van Netten
- Funding
(Source(s) of Monetary or Material Support)
Ziekenhuisgroep Twente, Saxion Enschede Academie gezondheidszorg
- Publications
- Brief summaryBackground of the study:
For the prevention of diabetic foot ulceration, evidence exists to support the use of home-monitoring of foot skin temperature by means of a hand-held infrared skin thermometer. However, the construct validity of skin temperature measurements is unknown. Factors such as time of day, activity, body temperature and environmental temperature may influence skin temperature changes and could lead to false positive or false negative results if applied as home-monitoring instrument. Increased knowledge is important for the optimization of the measurement procedure and for using temperature measurements as a home screening tooi by patients with diabetes.

Objective of the study:
This pilot study intends to describe the skin temperature changes of the foot in patients with diabetes during the day. The secondary objectives are to describe the relationship with ambulatory activity, body temperature, and environmental temperature.

Study design:
Prospective observational pilot study.

Study population:
Twenty patients with Diabetes Mellitus type 1 and 2, classified as Simms' 1 or 2, above 18 years of age. Patients with clinical signs of infection, ulceration, major amputation, fever or critical ischemia are excluded.

Primary study parameters/outcome of the study:
Skin temperature differenee between six spots of the foot of patients with diabetes during four moments the day.

Secundary study parameters/outcome of the study (if applicable):
Activity, body temperature and environmental temperature

Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable): After agreeing to participate, participants visit the outpatient clinic onee. During this appointment, participants will be provided with the devices and a diary to measure the temperature at home.
The participants monitor the skin temperature of their feet four times a day for the period of one week. After this week, a staff member of the research team will visit the patient at home to evaluate the process and retrieve
- Main changes (audit trail)
- RECORD1-mei-2015 - 26-jul-2015


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