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Completed

NCT Number: NCT02233179

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

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.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

37 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center

Tucson, Arizona, 85724, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Removable cast walker

Device

Offloading device that can be removed by patients.

Other names: Cast walker from Ossur, Reykjavik, Iceland

Irremovable cast walker

Device

Offloading device that cannot be removed by patients.

Other names: Cast walker from Ossur, Reykjavik, Iceland

Primary outcomes

  1. Wound size

    Time frame: 12 weeks

    Wound size was measured every week for 12 weeks

  2. Daily Physical Activities

    Time frame: 12 weeks

    Recorded using a body-worn sensor and measured every 4 weeks for 2 days.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • Qatar National Research Fund

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Sep 8, 2014
Registry last updated
Sep 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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