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

University of Arizona

Status: Completed

Conditions: Diabetic Foot

Treatments: Device: Irremovable cast walker; Device: Removable cast walker

Study type: Interventional

Funder types: Other

Identifiers

NCT02233179

0900000701

Details and patient eligibility

About

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.

Full description

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

Enrollment: 49 patients

Sex: All

Ages: 37 to 68 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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49 participants in 2 patient groups

Removable Cast Walker

Experimental group

Description:

An offloading device that can be removed by the patients

Treatment:

Device: Removable cast walker

Irremovable Cast Walker

Active Comparator group

Description:

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

Treatment:

Device: Irremovable cast walker