The Effect of Exercise on Wound Healing While Off-loading

NCT04280016 | Unknown DMC

• 1 other identifier: H1908192
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetes; off-loading; exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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).

• Body Mass Index

  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).

Study Arms (1)

Exercise Added to Off-loading

EXPERIMENTAL

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

Interventions

Exercise BEHAVIORAL

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.

Exercise Added to Off-loading

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Presence of an untreated infection, osteomyelitis, or gangrene

Sponsors & Collaborators

• Mercer University: lead

Study Sites (1)

Piedmont Healthcare

Atlanta, Georgia, 30309, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Deborah M. Wendland

  Mercer University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah M. Wendland, PhD

CONTACT

6785476775; wendland_dm@mercer.edu

Teri Biven, DPT

CONTACT

404.605.2743; Teri.Biven@piedmont.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The outcome assessor will be unaware of how much the participant participated in the exercise program. Exercise will occur away from the treatment area so that the care provider will be unaware of whether or not a patient is participating in the study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A pilot study using retrospective chart review and non-randomized controlled trial methodology (single group).

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: May 14, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available following the study conclusion and its dissemination (6 months after publication).
• Access Criteria: The information will be shared with researchers for meta-analyses through the data repository.

Locations

US (1)