Clinical trial NCT04280016: The Effect of Exercise on Wound Healing While Off-loading
Official title: The Effect of Exercise on Wound Healing in People With Diabetes Undergoing Off-loading Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Diabetes
off-loading
exercise
Lead sponsor: Mercer University
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A pilot study using retrospective chart review and non-randomized controlled trial methodology (single group).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Wound measurement size
timeFrame: Measurements of wound will be taken up to 12 weeks or until wound closure occurs, whichever is first.
Secondary outcomes:
measure: Summary of Diabetes Self-Care Activities Scale
timeFrame: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
measure: Body Mass Index
timeFrame: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
measure: Physical activity data using an activity monitor (e.g. StepWatch).
timeFrame: Measured at baseline for one week.
measure: Vibration sense
timeFrame: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
measure: Waist circumference
timeFrame: Measurement will be taken at baseline and at end of study (at 12 weeks or at wound closure, whichever occurs first).
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Healthcare
state: Georgia
Study officials:
affiliation: Mercer University
name: Deborah M. Wendland
role: PRINCIPAL_INVESTIGATOR
References: