Diabetic Foot
Conditions
Keywords
Diabetic foot ulcer
Brief summary
The aim of the study was to explore the association between activities of daily living ( measured using a body-worn sensor) on wound healing in diabetic patients. Since this was an exploratory study, there was no study hypothesis.
Detailed description
Diabetes patients with active foot ulcers were recruited and monitored for activities of daily living while wearing an offloading device.
Interventions
DEVICERemovable cast walker
Offloading device that can be removed by patients.
DEVICEIrremovable cast walker
Offloading device that cannot be removed by patients.
Sponsors
Qatar National Research Foundation, Qatar
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
37 Years to 68 Years
Healthy volunteers
No
Inclusion criteria
* age 18 or older with non-infected, non-ischemic foot ulcers * active neuropathic foot ulcer
Exclusion criteria
* major foot amputation * active Charcot arthropathy * ankle brachial index of 0.5 or less * history of substance abuse within 6 months * inability to walk 20m
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound size | 12 weeks | Wound size was measured every week for 12 weeks |
| Daily Physical Activities | 12 weeks | Recorded using a body-worn sensor and measured every 4 weeks for 2 days. |
Countries
United States
Outcome results
None listed