The Association Between Unprotected Standing, Walking and Wound Healing in Diabetes

Diabetic Foot Clinical Trial

Official title:

Body-worn Sensor Technology for Improving Diabetic Care During Activities of Daily Living

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233179
• Other study ID #: 0900000701
• Status: Completed
• Phase: N/A
• First received: August 8, 2014
• Last updated: September 3, 2014
• Start date: June 2009
• Est. completion date: November 2012

Study information

• Verified date: September 2014
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Diabetes patients with active foot ulcers were recruited and monitored for activities of daily living while wearing an offloading device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 37 Years to 68 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

Device:
• Removable cast walker
Offloading device that can be removed by patients.
• Irremovable cast walker
Offloading device that cannot be removed by patients.

Locations

Country	Name	City	State
United States	University Medical Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	Qatar National Research Foundation, Qatar

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound size	Wound size was measured every week for 12 weeks	12 weeks	Yes
Primary	Daily Physical Activities	Recorded using a body-worn sensor and measured every 4 weeks for 2 days.	12 weeks	No

External Links

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