None listed
Conditions
Brief summary
Foot ulcers are a frequent complication of 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 and this places them at high risk of developing foot ulceration. Clinical guidelines recommend the provision of protective footwear and pressure relieving insoles in the prevention of ulceration in the insensate foot. This needs to be guided by measuring pressure under the foot and subsequent modification of footwear or orthoses to provide optimal conditions for the prevention of ulceration. Many systems exist to measure pressure beneath the foot to determine how effective pressure relieving strategies are. Current validated systems consist of high numbers of sensors but are expensive, which limits implementation into routine clinical practice, and can be difficult to use for untrained clinicians. In this study, we will test how well an affordable portable multi-point pressure sensor module measures pressure at key sites during normal, overground, walking and whilst changing from sitting to standing and back. We will compare this to a validated gold-standard reference pressure measurement system. Clients of the Metro North Hospital and Health Services (MNHHS) community-based High-Risk Foot Clinic (HRFC) with peripheral neuropathy and no current foot ulcers will have pressure measurements taken prior to routine follow-up care. The results obtained from portable multi-point pressure sensor module will be compared to results from a laboratory insole testing system, which is considered to be “gold standard” for the measurements. Fifteen participants with diabetes mellitus type 1 or 2 and peripheral neuropathy will be included in the study. People with severe peripheral artery disease, a foot wound, severe foot deformities or unsteadiness in normal walking will be excluded from the study. When the study is finished, we will know if the portable multi-point pressure sensor module gives similar results as “gold standard” measurement system.
Interventions
The following will be performed one-to-one face-to-face with participants. All measurements will be conduced by the principal investigator and a co-investigator, both podiatrists. these measurements will take around 60 minutes and scheduled to occur immediately prior to the participants routine follow up at the high risk foot clinic.
Participants will complete a level walking test followed by a timed up-and-go test. This test sequence will be completed three times while wearing:
• portable mu
The following will be performed one-to-one face-to-face with participants. All measurements will be conduced by the principal investigator and a co-investigator, both podiatrists. these measurements will take around 60 minutes and scheduled to occur immediately prior to the participants routine follow up at the high risk foot clinic. Participants will complete a level walking test followed by a timed up-and-go test. This test sequence will be completed three times while wearing: • portable multi-point pressure sensor module with sensors placed in four standardised locations – plantar 1st metatarsal head, 5th metatarsal head, plantar hallux and 5th metatarsal base to cover areas of frequent ulceration and to have a mix of digit, forefoot and midfoot measurements (PG standard) • Portable multi-point pressure sensor module with one sensor placed at either the plantar hallux or 1st metatarsal head, and the other 3 sensors placed at anatomically relevant sites for the particular foot (PG anatomic). Anatomically relevant sites will be chosen by the Principal Researcher and would include sites of previous plantar ulceration, bony prominences exposed to plantar pressure, areas with evidence of hyperkeratosis of the skin or the apex of digits with a clawing deformity. • Gold standard Novel pedar® -X insoles (Novel GmbH, München, Germany) that measures pressure across the entire plantar surface. The order of portable multi-point pressure sensor module and Novel insoles will be randomized. Preferred walking speed will be measured (pedar®). Level walking test: Participants will be level walking on a 30m straight pathway at their preferred speed, until the scientifically valid minimum of 12 midgait steps per foot is collected (Arts and Bus, 2011). Timed up-and-go test: Participants will sit in a standard arm chair with a line marked 3 m in front of the chair. Participants will be briefed to stand up on the verbal signal “go”, walk to the line at their normal pace, turn, walk back to the chair and sit down again. Participants will be timed from the verbal “go” signal to when they have sat back down. This test will be repeated 3 times starting with the participants preferred foot (Podsiadlo and Richardson, 1991). Where time to perform these 3 tests varies by >5% outlier tests will be repeated up to a maximum of 6 tests. Participants will get adequate rest between measurements. Participants will be asked if they have rested enough before a new measurement is started.
Sponsors
Metro North Hospital and Health Service
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Diabetes mellitus Type 1 or Type 2 - Aged 18 years or older - Peripheral Neuropathy, as determined using a 10-gram Semmes Weinstein monofilament, in line with criteria from the IWGDF (Schaper et al, 2016) - Ability and willingness to cooperate with the study requirements
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study: - Peripheral artery disease, this will be excluded by the presence of triphasic pulse waveforms or by a toe brachial pressure index >0.75 (Brownrig et al, 2016) - Current diabetic foot ulcer - Charcot neuroarthropathy - Major amputation (i.e. above the ankle) - Not able to walk for 30 meters without external support (e.g. crutches or walking frame) - Unable to consent due to cognitive impairment or language limitations preventing understanding of provided information and hence capacity for informed consent.
Outcome results
None listed