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.

Inclusion Criteria:Provision of signed and dated informed consentStated willingness to comply with all study procedures and availability for the duration of the studyMale or Female, aged 18 yrs or olderDiabetes diagnosed or meets ADA criteria for Type 2 diabetesFoot ulcer of diabetic etiology, with all of the following characteristics:Ulcer size > 0.5cm2 and < 12cm2 at least 2 cm from any other ulcerUlcer with Wagner grade 1 or 2In case of multiple ulcers, select the largest ulcer that meets inclusion criteria.Exclusion Criteria:Patient participating in an interventional clinical trial within 1 month of visit 1Participant has Charcot's foot or other foot deformities that prevent adequate targeted ulcer offloadingParticipant has active severe infection or osteomyelitis at the time of the screening visitHistory of cancer within the last 3 years, other than non-melanoma skin cancerUse of adjunctive therapy within previous 30 daysCurrently receiving medication considered to be a systemic glucocorticoidPlan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or < 1 month from a prior ipsilateral (same side) vascular interventionPregnant or currently lactatingUncontrolled blood glucose with presence of urinary ketonesContraindications for exercise as define by the American Heart Association/American College of Sports Medicine Guidelines for Exercise Testing and Prescription [1]Bilateral wound or ulcerCurrent infection of COVID19Any history of concomitant medical condition that, in the opinion of the investigator(s), would compromise the participants ability to safely complete the study