The Effect of Exercise on Wound Healing While Off-loading

October 15, 2021 updated by: Deborah M. Wendland, Ph.D., Mercer University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Added to Off-loading
Participants in this arm will participate in exercise at the healthcare facility one time a week (away from where wound care is provided) and be instructed in a home exercise program that they will be encouraged to perform at least three days per week with no more than two days between sessions. Wound care will continue at the facility as is standard, utilizing off-loading.
Behavioral: Exercise
Participants will participate in an exercise session with non-weight-bearing exercise that the participant is able to perform with off-loading (e.g. total contact cast) intact. They will also be instructed in a home exercise program so that exercise can be performed three days per week with no more than two days between sessions. These participants will also receive standard wound care with off-loading.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summary of Diabetes Self-Care Activities Scale
Time Frame: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Participation in exercise. Using two questions, this scale measures the number of days that an individual reports doing physical activity (question 1) or specific exercise (question 2). Scores on each question could range from 0 to 7 days. The higher the number, the more days the individual participates in the activity or exercise.
Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Body Mass Index
Time Frame: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Height and weight measurements will be combined and reported as BMI and measured in kg/m^2.
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).
Time Frame: Measured at baseline for one week.
A week-long measurement of strides will be taken at the begin of the study.
Measured at baseline for one week.
Vibration sense
Time Frame: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Vibration sense will be measured using a Bio-Thesiometer to assess for degree of peripheral neuropathy. A higher score would indicate decreased sensory perception of vibration.
Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Waist circumference
Time Frame: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Waist circumference will be taken in cm as a marker of body composition.
Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mercer University

Investigators

  • Principal Investigator: Deborah M. Wendland, Mercer University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2021

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

February 19, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 21, 2020

Study Record Updates

Last Update Posted (Actual)

October 25, 2021

Last Update Submitted That Met QC Criteria

October 15, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1908192

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified closure rate data will be made available through a repository upon conclusion of the study and its dissemination.

IPD Sharing Time Frame

Data will be available following the study conclusion and its dissemination (6 months after publication).

IPD Sharing Access Criteria

The information will be shared with researchers for meta-analyses through the data repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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