Diabetes mellitus, diabetic foot disease, foot ulcer
Conditions
Interventions
None
Sponsors
Amsterdam Movement Sciences and ZGT Wetenschapsfonds
Eligibility
Inclusion criteria
Inclusion criteria: - Age = 18 years - Diabetes mellitus type 1 or 2 - Plantar foot ulcer – University of Texas grade 1A or 2A - Loss of protective sensation - Ambulatory status
Exclusion criteria
Exclusion criteria: - Treated with a non-removable total contact cast - Open amputation site - Active Charcot neuro-osteo arthropathy - Plantar ulcer on the contralateral foot - Wound, Ischemia, foot Infection (WIfI), ischemia score 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to foot ulcer healing | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percentage healed foot ulcers at 12 weeks. We hypothesize the same for percentage healed foot ulcers at 12 weeks as for the primary outcome. - Percentage healed foot ulcers at 20 weeks. We hypothesize the same for percentage healed foot ulcers at 20 weeks as for the primary outcome. - Barefoot and in-device plantar pressures: peak pressure, pressure time integral, pressure gradient. We hypothesize that lower peak pressure and pressure time integral shortens the time to ulcer healing. Pressure gradient is an exploratory outcome. - Weight-bearing activity: number of daily steps, variation in daily steps, bouts, bout duration, walking symmetry, variability, stability and regularity. We hypothesize that lower number of daily steps is associated with shorter ulcer healing times. The other outcomes are exploratory, as barely or no previous research on these outcomes is available in this population. - Device 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 higher device adherence is associated with shorter ulcer healing times. - Offloading device wearing time: see outcomes device adherence. We hypothesize that device wearing time is highly associated with device adherence, and the same hypotheses apply. - Amputations. This is a descriptive outcome. - Quality of life. This is a descriptive outcome. - Cardiff Wound Impact Scale. We hypothesize that higher score on the Cardiff Wound Impact Scale (0-100, poor-good health-related quality of life) is associated with shorter ulcer healing times. - Falls. This is an exploratory and a safety outcome (offloading devices could result in falls). | — |
Contacts
Public ContactChantal Hulshof
Amsterdam UMC, location AMC
Outcome results
None listed