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

University of Arizona49 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Diabetic Foot

Interventions

Removable cast walkerDEVICE

Offloading device that can be removed by patients.

Irremovable cast walkerDEVICE

Offloading device that cannot be removed by patients.

Eligibility

Sex: ALLMin age: 37 YearsMax age: 68 Years

Medical Language ↔ Plain English

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

Locations (1)

University Medical Center

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Wound size

Wound size was measured every week for 12 weeks

Time frame: 12 weeks

Daily Physical Activities

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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