Non-weight bearing exercise to heal diabetic foot ulcers faster

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

This study is testing if a special exercise program can help people with type 2 diabetes heal their foot ulcers faster than just standard wound care alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of Michigan (Academic / other)
• Locations: 1 site (Ann Arbor, Michigan)
• Trial ID: NCT05603273 on ClinicalTrials.gov

What this trial studies

This study aims to enhance the healing of diabetic foot ulcers (DFU) by evaluating the effects of a non-weight bearing exercise program compared to standard wound care alone. Participants with type 2 diabetes and existing foot ulcers will be randomly assigned to either the exercise group or the control group, both receiving standard care. Over a 6-week period, the study will assess blood flow to the ulcer and overall metabolism through various tests, including blood draws and exercise testing. The goal is to determine if exercise can improve healing outcomes for patients with DFU.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with type 2 diabetes and a diabetic foot ulcer that meets specific size and grade criteria.

Not a fit: Patients with active severe infections, Charcot's foot, or other foot deformities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly accelerate healing times for patients with diabetic foot ulcers.

How similar studies have performed: While the specific approach of non-weight bearing exercise for DFU is novel, similar studies have shown positive outcomes with exercise interventions in improving healing in diabetic patients.

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

Where this trial is running

Ann Arbor, Michigan

• School of Kinesiology — Ann Arbor, Michigan, United States (Recruiting)

Study contacts

• Principal investigator: Jacob Haus, PhD — University of Michigan
• Study coordinator: Jacob Haus, PhD

Conditions Type2diabetes; Foot Ulcer