Clinical trial NCT05603273: Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers
Official title: Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type2diabetes
Foot Ulcer
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This research is being done because people with diabetes have reduced healing capacity. This can be problematic because wounds that do not heal may turn into ulcers which may lead to more severe complications. Non-weight bearing exercise has many positive health benefits that improve metabolic and vascular health which will then improve healing time. Therefore, the purpose of this study is to evaluate the positive effects of non-weight bearing exercise. Once the effects of non-weight bearing exercise are confirmed, progress towards the prevention and treatment of diabetic foot ulcers and complications may be possible. Potential participants are eligible for the study if diagnosed with type 2 diabetes and have a foot ulcer or wound. Approximately 40 subjects with Type 2 Diabetes are expected to complete this study. Participation in this study requires medical clearance following a screening visit and then being randomly assigned to a non-weight bearing exercise training group or a control group. Both groups will receive standard diabetic and wound care. Subjects will complete 7 study visits at the University of Michigan. The research tests during these visits will include measures of body composition, oral glucose tolerance test, exercise testing, blood draws, vascular function measurements, wound measurement, single-leg exercise session and group randomization If randomized to the Exercise Group subjects will be asked to visit the University of Michigan three days a week for 6 weeks. During each visit during this 6-week period, subjects will perform exercise training by completing 30 minutes of single-leg exercise at approximately 50% of a predetermined maximal effort. Regardless of the group subjects are randomized to, all will receive standard care for the management of diabetes foot ulcer/wound.

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

Primary outcomes:
measure: wound size and depth
timeFrame: 6 weeks
Secondary outcomes:
measure: blood flow
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: School of Kinesiology
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jacob Haus, PhD
role: PRINCIPAL_INVESTIGATOR
References: