Comprehensive load-capacity model of diabetic foot ulcer development

Biomechanical, activity and adherence profiles of people with diabetes in a comprehensive load-capacity model of foot ulcer development

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26874

Enrollment

Registered

2020-08-17

Start date

2020-08-18

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus, diabetic foot disease, foot ulcer

Interventions

None

Eligibility

Inclusion criteria

Inclusion criteria: - Age = 18 years - Diabetes mellitus type 1 or 2 - Recent history of a diabetic foot ulcer (600 kPa) - Loss of protective sensation - Ambulatory status

Exclusion criteria

Exclusion criteria: - Foot ulcer - Open amputation site - Active Charcot neuro-osteo arthropathy - Wound, Ischemia, foot Infection (WIfI), ischemia score 3

Design outcomes

Primary

Measure	Time frame
Diabetic foot ulcer	—

Secondary

Measure	Time frame
- Pre-sign of diabetic foot ulceration, such as abundant callus, haemorrhage or a blister. We hypothesize the same for pre-signs of diabetic foot ulceration as for the primary outcome. - Barefoot and in-shoe plantar pressures during different activities: peak pressure, pressure time integral, pressure gradient. We hypothesize that peak pressure is highest during mid-gait level walking at higher speed, while pressure-time integral is highest during mid-gait level walking at lower speed, compared to walking at other speed and other activities. Pressure gradient is an exploratory outcome. - Physical activity: number of daily steps, variation in daily steps, number of walking bouts, bout duration, walking symmetry, variability, stability and regularity. These outcomes are exploratory, as conflicting or no previous research on these outcomes is available in this population. - Physical performance: Timed Up and Go test, Short Physical Performance Battery. These outcomes are exploratory in relation to our primary outcome. We further hypothesize that our cohort will have lower performance in comparison to benchmarked population scores. - Footwear adherence: percentage of steps / hours per day, percentage of steps /daily hours per weight-bearing activities duration, percentage of steps / hours per day indoor/outdoor. We hypothesize that footwear adherence is highest during working hours, during walking (compared to other weight-bearing and non-weight-bearing activities), and outdoors (compared to indoors). - Footwear wearing time: see outcomes footwear adherence + percentage per steps / hours per day per season. We hypothesize that footwear wearing time is highly associated with footwear adherence, and the same hypotheses apply. Furthermore, we hypothesize that footwear wearing time is highest during winter (compared to other seasons). - Footwear usability. We hypothesize that higher footwear usability is associated with higher footwear adherence and footwear wearing time. -	—

Measure

Time frame

- Pre-sign of diabetic foot ulceration, such as abundant callus, haemorrhage or a blister. We hypothesize the same for pre-signs of diabetic foot ulceration as for the primary outcome. - Barefoot and in-shoe plantar pressures during different activities: peak pressure, pressure time integral, pressure gradient. We hypothesize that peak pressure is highest during mid-gait level walking at higher speed, while pressure-time integral is highest during mid-gait level walking at lower speed, compared to walking at other speed and other activities. Pressure gradient is an exploratory outcome. - Physical activity: number of daily steps, variation in daily steps, number of walking bouts, bout duration, walking symmetry, variability, stability and regularity. These outcomes are exploratory, as conflicting or no previous research on these outcomes is available in this population. - Physical performance: Timed Up and Go test, Short Physical Performance Battery. These outcomes are exploratory in relation to our primary outcome. We further hypothesize that our cohort will have lower performance in comparison to benchmarked population scores. - Footwear adherence: percentage of steps / hours per day, percentage of steps /daily hours per weight-bearing activities duration, percentage of steps / hours per day indoor/outdoor. We hypothesize that footwear adherence is highest during working hours, during walking (compared to other weight-bearing and non-weight-bearing activities), and outdoors (compared to indoors). - Footwear wearing time: see outcomes footwear adherence + percentage per steps / hours per day per season. We hypothesize that footwear wearing time is highly associated with footwear adherence, and the same hypotheses apply. Furthermore, we hypothesize that footwear wearing time is highest during winter (compared to other seasons). - Footwear usability. We hypothesize that higher footwear usability is associated with higher footwear adherence and footwear wearing time. -

—

Contacts

Public ContactChantal Hulshof

Amsterdam UMC, location AMC

c.m.hulshof@amsterdamumc.nl020-5666915

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)