Recruiting

Exercise

Sponsor:

Mercer University

Code:

NCT04280016

Conditions

Diabetic Foot Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise

Study Details

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

Study ID

NCT04280016

Start date

May 14, 2021

Status verified date

Oct, 2021

Completion date

May, 2023

Anticipated

Primary completion date

May, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Wound measurement size [ Time Frame: Measurements of wound will be taken up to 12 weeks or until wound closure occurs, whichever is first. ]

Central Contacts and Locations

Central contacts

Deborah M. Wendland, PhD

6785476775wendland_dm@mercer.edu

Teri Biven, DPT

404.605.2743Teri.Biven@piedmont.org

Locations

Piedmont Healthcare

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Teri Biven, DPT

404-605-2743Teri.Biven@piedmont.org

More Information

Sponsor

Mercer University

Last update posted

Oct 25, 2021

Last verified

Oct, 2021

Keywords

  • Diabetes
  • off-loading
  • exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mercer University on 2021-10-25.