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Clinical Trials/NCT04280016
NCT04280016
Unknown
Not Applicable

The Effect of Exercise on Wound Healing in People With Diabetes Undergoing Off-loading Treatment

Mercer University1 site in 1 country15 target enrollmentMay 14, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Foot Ulcer
Sponsor
Mercer University
Enrollment
15
Locations
1
Primary Endpoint
Wound measurement size
Last Updated
4 years ago

Overview

Brief Summary

This study seeks to establish the effect of adding exercise to off-loading interventions on the healing time for people with diabetes mellitus and a foot ulcer. Hypothesis: Consistent with the literature, results are expected to resemble the accelerated healing seen when older adults exercised in the presence of wounds.

Detailed Description

The purpose of this project is to establish the effect of the addition of exercise to an off-loading intervention on the healing time for people with diabetes mellitus and a foot ulcer. While benefits of physical activity and exercise are clear, the benefit of exercise on wound healing in individuals with diabetes has not been elucidated. It is critical to better understand how prescribed exercise effects the healing speed in patients receiving wound care with appropriate off-loading. If exercise does decrease healing time, the benefit to the patient may include lower cost, decreased risk of infection, decreased burden on a caregiver, and improved quality of life.

Registry
clinicaltrials.gov
Start Date
May 14, 2021
End Date
May 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Deborah M. Wendland, Ph.D.

Associate Professor

Mercer University

Eligibility Criteria

Inclusion Criteria

  • Have diabetes
  • Have an active plantar ulceration
  • With or without peripheral neuropathy
  • Able to safely exercise
  • Receiving care for their plantar ulceration, including off-loading

Exclusion Criteria

  • Presence of an untreated infection, osteomyelitis, or gangrene

Outcomes

Primary Outcomes

Wound measurement size

Time Frame: Measurements of wound will be taken up to 12 weeks or until wound closure occurs, whichever is first.

Charts will be reviewed for normal wound measurements as is part of standard care. Measurements are expected to be reported as surface area (cm\^2) and/or volume (cm\^3). Wound closure will be defined as epithelialization across the entire wound bed and would be expected to correlate to no surface area or volume of wound being reported.

Secondary Outcomes

  • Summary of Diabetes Self-Care Activities Scale(Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).)
  • Physical activity data using an activity monitor (e.g. StepWatch).(Measured at baseline for one week.)
  • Vibration sense(Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).)
  • Waist circumference(Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).)
  • Body Mass Index(Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).)

Study Sites (1)

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