The Association Between Unprotected Standing, Walking and Wound Healing in Diabetes
Not Applicable
Completed
- Conditions
- Diabetic Foot
- Interventions
- Device: Removable cast walkerDevice: Irremovable cast walker
- Registration Number
- NCT02233179
- Lead Sponsor
- University of Arizona
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Removable Cast Walker Removable cast walker An offloading device that can be removed by the patients Irremovable Cast Walker Irremovable cast walker A removable cast rendered irremovable using instant total contact cast, so patients cannot remove offloading device.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Medical Center
🇺🇸Tucson, Arizona, United States