None listed
Conditions
Brief summary
Foot ulcers are a frequent problem in people with diabetes. These wounds can be serious, and may result in amputation or even death, if left untreated. A frequent cause of these wounds is high pressure under the foot. Prevention of such wounds is of great importance. This is especially the case in people who cannot feel touch or pressure on their foot, which is called peripheral neuropathy, or an insensate foot. Reduced foot sensation can prevent people from noticing when high pressure develops. Early detection of high pressure in people with an insensate foot can be beneficial in avoiding these wounds. When high pressure is detected earlier, treatment can start earlier, to avoid ulcers forming. For this, pressure needs to be monitored on a daily basis. The long term goal of this project is to develop an insole for people with diabetes to measure pressure on the soles of the feet during daily activities. The current study will test how well the insoles measure pressure during a series of everyday activities. We will compare this to laboratory pressure measurement systems in the QUT Health Clinic. Participants will visit the QUT Health Clinic once. The results obtained from the new insoles will be compared to results from a laboratory insole testing system and a force plate, which are considered to be “gold standard” for some of the measurements. Fifteen participants with diabetes mellitus type 1 or 2 and peripheral neuropathy will be included in the study. People with vascular disease, a foot wound, or severe foot deformities will be excluded from the study. When the study is finished, we know if the new insoles give similar results as “gold standard” measurement system. We also know if insoles give similar results at similar steps. This will tell us if the insoles have potential to be used in daily life.
Interventions
Participants will use new biofeedback insoles (Bio Insole) as well as gold standard (Novel Pedar-X) insoles during various ambulatory activities,. Bio Insoles consist of a pressure sensing insole and attached electronic recording device. Patients will be tested in a single 90 min session, with Bio Insole or Pedar-X insoles used for approximately 50% of the time with the order of use randomised. Each patient will use both insoles. Activities consist of straight ground level walking, treadmill wa
Participants will use new biofeedback insoles (Bio Insole) as well as gold standard (Novel Pedar-X) insoles during various ambulatory activities,. Bio Insoles consist of a pressure sensing insole and attached electronic recording device. Patients will be tested in a single 90 min session, with Bio Insole or Pedar-X insoles used for approximately 50% of the time with the order of use randomised. Each patient will use both insoles. Activities consist of straight ground level walking, treadmill walking (normal speed, increased and decreased speed, ascent and descent), timed up and go test, starting and stopping on ground level walking and standing.. This is a single-centre, laboratory, within-subject design, observational study.
Sponsors
Wound Management Innovation CRC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Diabetes mellitus type 1 or 2 - Aged 18 years or older - Peripheral Neuropathy (as determined using a 10-gram Semmes Weinstein monofilament, in line with criteria from the International Working Group on the Diabetic Foot (IWGDF; Schaper et al, 2016) - Ability and willingness to cooperate with the study requirements
Exclusion criteria
- Peripheral artery disease, determined by a toe pressure <30mmHg (Hinchliffe et al, 2016) - Diabetic foot ulcer - Charcot neuroarthropathy - Major amputation (i.e. above the ankle) - Not able to walk for 30m. without external support (e.g. crutches)
Outcome results
None listed