Diabetes Mellitus
Conditions
Keywords
plantar pressure, shoe insert, ulcer prevention
Brief summary
The goal of this cross-sectional study is to evaluate a new shoe insole manufacturing method with the goal of further preventing foot ulceration for people with diabetes. This is achieved by decreasing pressure under risk areas of the foot, often on the insole; the interface between the shoe and the foot. The main question it aims to answer is: Does a thickness-varied surface based on plantar pressure measurement decrease pressure at high risk areas compared to even thickness surfaces. Researchers will compare three different pairs of insoles for each participant. Participants will partake in two sessions. The first one being a pre-measurement and foot status for manufacturing the insoles. During the second session, three pairs of insoles will in a random order be tested for each participant. The pressure measurement of the insoles will be made using F-Scan(TM), while participants walk.
Interventions
DEVICEMilled thickness varied soft upper surface, based on plantar pressure measurement
This custom made shoe insole is milled, with a thickness varied soft upper surface ranging from 0-6mm in thickness. The base of the insole is 45 shore Ethylene-vinyl acetate (EVA). This intervention makes the insole from an individual foot scan, a plantar pressure measurement from the individual and the shoe model to mill a finished custom made shoe insole with a soft upper surface. It is difficult in clinical practice of making shoe inserts to create a thickness varied soft upper with different zones all over the insole. Furthermore, a soft upper requires a physical positive model to be made of the foot and staff must spend time to grind the insole to an acceptable shape. A milled version would be more effective since it require no physical foot model, little to no work grinding the insole and enables the use of thickness-variations. It also enables the use of data-based insole-manufacturing, such as data from plantar pressure measurements.
DEVICE3mm soft upper surface
This intervention has a 3mm soft layer on the insole, milled with a 45 shore base of the custom made insole. This is one of the most commonly used designs in clinical practice.
DEVICENo soft upper surface
This intervention has a no soft layer on the insole, milled with a 45 shore base of the custom made insole. This is one of the most commonly used designs in clinical practice.
Sponsors
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
three-intervention cross over study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over 18 years of age at the date of signing consent. * Diabetes mellitus 1 or 2 * Diabetic foot risk group 2: Signs of distal neuropathy and/or peripheral circulatory disorder. * Able to walk 10 meters without walking aids * Able to speak and understand Swedish
Exclusion criteria
* Diabetic foot risk group 3: Distal neuropathy or peripheral circulatory disorder and foot ulcers, or amputation, foot deformity of clinical importance or skin pathology. * Diabetic foot risk group 4: Occuring foot ulcer, severe osteoarthropathy or chronic foot pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plantar pressure | Pre-measurement used for insole design at first meeting. Intervention-measurement for all patients and interventions at second meeting, approximately 3-4 weeks after pre-measurement. | Measured plantar pressure (kPa) differences between the arms/interventions. |
Countries
Sweden
Outcome results
None listed