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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot
• Intervention / Treatment: Device: Removable cast walker; Device: Irremovable cast walker

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 37 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Removable Cast Walker; An offloading device that can be removed by the patients	Device: Removable cast walker; Offloading device that can be removed by patients.; Other Names: Cast walker from Ossur, Reykjavik, Iceland
Active Comparator: Irremovable Cast Walker; A removable cast rendered irremovable using instant total contact cast, so patients cannot remove offloading device.	Device: Irremovable cast walker; Offloading device that cannot be removed by patients.; Other Names: Cast walker from Ossur, Reykjavik, Iceland

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound size	Wound size was measured every week for 12 weeks	12 weeks
Daily Physical Activities	Recorded using a body-worn sensor and measured every 4 weeks for 2 days.	12 weeks

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: Qatar National Research Foundation, Qatar
• Investigators: Principal Investigator: David G Armstrong, DPM, MD, PhD, University of Arizona

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: August 8, 2014
• First Submitted That Met QC Criteria: September 3, 2014
• First Posted (Estimate): September 8, 2014

Study Record Updates

• Last Update Posted (Estimate): September 8, 2014
• Last Update Submitted That Met QC Criteria: September 3, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Diabetic foot ulcer
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Cysteine Proteinase Inhibitors; Calpastatin
• Other Study ID Numbers: 0900000701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No