Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers

Launched by UNIVERSITY OF MICHIGAN · Oct 31, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether a specific type of exercise, called non-weight bearing exercise, can help diabetic foot ulcers heal faster when combined with standard wound care. The researchers want to find out if this exercise improves blood flow to the ulcer and overall body metabolism, which may aid in healing. Over a period of 6 weeks, participants will be divided into two groups: one will do the exercise along with standard care, while the other will receive only standard care.

To participate, individuals must be at least 18 years old, have type 2 diabetes, and have a diabetic foot ulcer that meets certain criteria. They should not have any severe infections or other conditions that could interfere with the study. Participants will undergo tests to check blood flow and fitness levels, and they'll need to be available for the entire study. This trial is currently recruiting, and it's an opportunity for eligible individuals to potentially improve their healing process while contributing to important research.

Gender

ALL

Eligibility criteria

• 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