Back to resultsThe Association Between Unprotected Standing, Walking and Wound Healing in Diabetes
Primary Purpose
Diabetic Foot
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Removable cast walker
Irremovable cast walker
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot focused on measuring Diabetic foot ulcer
Eligibility Criteria
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
Sites / Locations
- University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Removable Cast Walker
Irremovable Cast Walker
Arm Description
An offloading device that can be removed by the patients
A removable cast rendered irremovable using instant total contact cast, so patients cannot remove offloading device.
Outcomes
Primary Outcome Measures
Wound size
Wound size was measured every week for 12 weeks
Daily Physical Activities
Recorded using a body-worn sensor and measured every 4 weeks for 2 days.
Secondary Outcome Measures
Full Information
NCT ID
NCT02233179
First Posted
August 8, 2014
Last Updated
September 3, 2014
Sponsor
University of Arizona
Collaborators
Qatar National Research Foundation, Qatar
1. Study Identification
Unique Protocol Identification Number
NCT02233179
Brief Title
The Association Between Unprotected Standing, Walking and Wound Healing in Diabetes
Official Title
Body-worn Sensor Technology for Improving Diabetic Care During Activities of Daily Living
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
Qatar National Research Foundation, Qatar
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot
Keywords
Diabetic foot ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Removable Cast Walker
Arm Type
Experimental
Arm Description
An offloading device that can be removed by the patients
Arm Title
Irremovable Cast Walker
Arm Type
Active Comparator
Arm Description
A removable cast rendered irremovable using instant total contact cast, so patients cannot remove offloading device.
Intervention Type
Device
Intervention Name(s)
Removable cast walker
Other Intervention Name(s)
Cast walker from Ossur, Reykjavik, Iceland
Intervention Description
Offloading device that can be removed by patients.
Intervention Type
Device
Intervention Name(s)
Irremovable cast walker
Other Intervention Name(s)
Cast walker from Ossur, Reykjavik, Iceland
Intervention Description
Offloading device that cannot be removed by patients.
Primary Outcome Measure Information:
Title
Wound size
Description
Wound size was measured every week for 12 weeks
Time Frame
12 weeks
Title
Daily Physical Activities
Description
Recorded using a body-worn sensor and measured every 4 weeks for 2 days.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
37 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G Armstrong, DPM, MD, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
12. IPD Sharing Statement
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The Association Between Unprotected Standing, Walking and Wound Healing in Diabetes
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