Recruiting

Self-directed vs. Therapist-directed

Sponsor:

Mercer University

Code:

NCT04310137

Conditions

Diabetic Foot Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Therapist-Directed Re-loading

Study Details

Brief summary:

This study is designed to evaluate if how people are told to return to walking after a skin injury affects whether or not they develop new (recurrence) skin breakdown on their feet. The people in this study will have diabetes and have a recently closed foot ulcer. About half will be specifically told how to return to walking and the other half will be told to return to walking slowly. How people naturally return to walking will also be established.

Conditions

Diabetic Foot Ulcer

Study ID

NCT04310137

Start date

May 1, 2021

Status verified date

Oct, 2021

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • With or without peripheral neuropathy
  • Able to safely exercise
  • Have a recently closed plantar ulceration

Exclusion Criteria:

  • Presence of an open plantar ulceration
  • Presence of an untreated infection
  • Presence of osteomyelitis or gangrene

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Therapist-Directed Re-loading

Participants in this arm will be instructed to increase their activity by walking 10% more steps per day than the steps recorded in the most recent activity monitoring (i.e. StepWatch) measurement (e.g. 10% more than the initial monitoring values and 10% more than the second monitoring values once they are completed).

no intervention: Self-Directed Re-loading

Participants in this arm will be instructed to slowly increase their walking.

Interventions

Therapist-Directed Re-loading

Therapist will specifically direct participant to increase walking by 10% as measured at each of the activity monitoring assessments. In addition, the participant will be asked to monitor foot temperature to mitigate risk for breakdown.

Primary outcome measure

  • Incidence of Ulcer Recurrence [ Time Frame: Over up to 18 months of follow-up. ]
  • Change in walking behavior (steps) [ Time Frame: Assessed initially and every 6 months for 1 week for up to 18 months. ]
  • Change in walking behavior (step timing) [ Time Frame: Assessed initially and every 6 months for 1 week for up to 18 months. ]

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
  • re-loading
  • ulcer recurrence

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.