Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers
The goal of this study is to improve the therapeutic management of diabetic foot ulcers (DFU). The main questions to answer are if a program of non-weight bearing exercise helps the DFU heal faster than standard wound care. This randomized clinical trial will determine how blood flow to the ulcer and whole body metabolism may be improved with exercise. Participants will be randomized to either exercise + standard wound care or standard wound care alone and undergo testing for leg blood flow, fitness and measures of metabolism through blood draws. The intervention period is 6-weeks. Eligible participants must have an existing foot ulcer uncomplicated by infection and be medically cleared to exercise.
Conditions:
🦠 Type2diabetes 🦠 Foot Ulcer
🗓️ Study Start (Actual) 13 December 2023
🗓️ Primary Completion (Estimated) 30 June 2025
✅ Study Completion (Estimated) 30 June 2026
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Ann Arbor, Michigan, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Provision of signed and dated informed consent
    • 2. Stated willingness to comply with all study procedures and availability for the duration of the study
    • 3. Male or Female, aged 18 yrs or older
    • 4. Diabetes diagnosed or meets ADA criteria for Type 2 diabetes
    • 5. Foot ulcer of diabetic etiology, with all of the following characteristics:
    • * Ulcer size \> 0.5cm2 and \< 12cm2 at least 2 cm from any other ulcer
    • * Ulcer with Wagner grade 1 or 2
    • 6. In case of multiple ulcers, select the largest ulcer that meets inclusion criteria.

    Exclusion Criteria:

    • 1. Patient participating in an interventional clinical trial within 1 month of visit 1
    • 2. Participant has Charcot's foot or other foot deformities that prevent adequate targeted ulcer offloading
    • 3. Participant has active severe infection or osteomyelitis at the time of the screening visit
    • 4. History of cancer within the last 3 years, other than non-melanoma skin cancer
    • 5. Use of adjunctive therapy within previous 30 days
    • 6. Currently receiving medication considered to be a systemic glucocorticoid
    • 7. Plan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or \< 1 month from a prior ipsilateral (same side) vascular intervention
    • 8. Pregnant or currently lactating
    • 9. Uncontrolled blood glucose with presence of urinary ketones
    • 10. Contraindications for exercise as define by the American Heart Association/American College of Sports Medicine Guidelines for Exercise Testing and Prescription \[1\]
    • 11. Bilateral wound or ulcer
    • 12. Current infection of COVID19
    • 13. Any history of concomitant medical condition that, in the opinion of the investigator(s), would compromise the participants ability to safely complete the study
Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 26 October 2022
  • First Submitted that Met QC Criteria 31 October 2022
  • First Posted 2 November 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 January 2024
  • Last Update Posted 30 January 2024
  • Last Verified January 2024