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

NCT ID: NCT02233179

Last Updated: 2014-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-11-30

Brief Summary

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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

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

Conditions

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Diabetic Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Removable Cast Walker

An offloading device that can be removed by the patients

Group Type EXPERIMENTAL

Removable cast walker

Intervention Type DEVICE

Offloading device that can be removed by patients.

Irremovable Cast Walker

A removable cast rendered irremovable using instant total contact cast, so patients cannot remove offloading device.

Group Type ACTIVE_COMPARATOR

Irremovable cast walker

Intervention Type DEVICE

Offloading device that cannot be removed by patients.

Interventions

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Removable cast walker

Offloading device that can be removed by patients.

Intervention Type DEVICE

Irremovable cast walker

Offloading device that cannot be removed by patients.

Intervention Type DEVICE

Other Intervention Names

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Cast walker from Ossur, Reykjavik, Iceland Cast walker from Ossur, Reykjavik, Iceland

Eligibility Criteria

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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
Minimum Eligible Age

37 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qatar National Research Foundation, Qatar

UNKNOWN

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David G Armstrong, DPM, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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University Medical Center

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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0900000701

Identifier Type: -

Identifier Source: org_study_id

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