Evaluating plantar foot pressure in a novel diabetic offloading device
Research type
Research Study
Full title
Does a novel diabetic offloading boot (PulseFlow DF) reduce the plantar foot pressures compared to usual standard care? A proof of concept pilot study.
IRAS ID
198005
Contact name
Anne-Marie Keenan
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
0 years, 4 months, 10 days
Research summary
Diabetic foot ulcers have severe social, physical and financial consequences. One gold standard treatment is to relieve pressure through the use of specialised foot wear. A new type of footwear (PulseFlow DF) has recently become available but it is unclear whether it is more effective than what is usually offered to patients. This study will test whether the new footwear is any better at relieving pressure on the foot.\nThis study is an observational proof of concept study which will assess, in a laboratory-type setting with a small group of patients, whether the new footwear does reduce pressure on the foot. It will recruit 36 patients with a diabetic foot ulcer with adequate blood supply to the foot who are able to walk independently. These patients will be recruited from one diabetic foot clinic. \nThe participants will be asked to attend an appointment at a nearby specialist centre. At this appointment the participant will be asked to complete one brief questionnaire that explores their attitudes to wearing specialist footwear. An electronic insole which measures pressure will be inserted into their current shoe and the participant will be asked to walk 20 feet. This will then be repeated wearing a standard shoe (‘sham shoe’) and then repeated wearing the new PulseFlow DF footwear. Pressure measurements will be recorded for each type of footwear. This should not take longer than 1 hour in total. No other follow up appointments will be required in relation to this study.\nThis study is being conducted to fulfil the requirements of an MSc dissertation. The MSc is being funded by the National Institute for Health Research.\n
REC name
North of Scotland Research Ethics Committee 1
REC reference
17/NS/0027
Date of REC Opinion
14 Mar 2017
REC opinion
Favourable Opinion