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