The Effect of Exercise on Wound Healing While Off-loading

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04280016
• Other study ID #: H1908192
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2021
• Est. completion date: May 2023

Study information

• Verified date: October 2021
• Source: Mercer University
• Contact: Deborah M. Wendland, PhD
• Phone: 6785476775
• Email: wendland_dm[@]mercer.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer

Intervention

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.

Locations

Country	Name	City	State
United States	Piedmont Healthcare	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Mercer University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound measurement size	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	Summary of Diabetes Self-Care Activities Scale	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).
Secondary	Body Mass Index	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).
Secondary	Physical activity data using an activity monitor (e.g. StepWatch).	A week-long measurement of strides will be taken at the begin of the study.	Measured at baseline for one week.
Secondary	Vibration sense	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).
Secondary	Waist circumference	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).