Type2diabetesNCT05603273
Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers
A study testing non-weight bearing exercise in people with Type2diabetes and Foot Ulcer, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type2diabetes, Foot Ulcer
- What is being tested?
- non-weight bearing exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or Female, aged 18 yrs or older
- Diabetes diagnosed or meets ADA criteria for Type 2 diabetes
- 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
- In case of multiple ulcers, select the largest ulcer that meets inclusion criteria.
Who cannot join
- Patient participating in an interventional clinical trial within 1 month of visit 1
- Participant has Charcot's foot or other foot deformities that prevent adequate targeted ulcer offloading
- Participant has active severe infection or osteomyelitis at the time of the screening visit
- History of cancer within the last 3 years, other than non-melanoma skin cancer
- Use of adjunctive therapy within previous 30 days
- Currently receiving medication considered to be a systemic glucocorticoid
Show all 13Show fewer
- Plan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or < 1 month from a prior ipsilateral (same side) vascular intervention
- Pregnant or currently lactating
- Uncontrolled blood glucose with presence of urinary ketones
- Contraindications for exercise as define by the American Heart Association/American College of Sports Medicine Guidelines for Exercise Testing and Prescription [1]
- Bilateral wound or ulcer
- Current infection of COVID19
- Any history of concomitant medical condition that, in the opinion of the investigator(s), would compromise the participants ability to safely complete the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Type2diabetes, Foot Ulcer
- Being tested
- non-weight bearing exercise
- Medical subject headings
- Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-weight bearing exerciseBehavioural
exercise on a non-weight bearing device at 50% of peak capacity, 3 days per week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| standard wound care | No intervention | normal wound care according to current clinical practice |
| non-weight bearing exercise + standard wound care | Experimental | normal wound care according to current clinical practice with the addition of a weekly exercise routine Receives: Behavioral: non-weight bearing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound size and depth
wound site and depth
Measured: 6 weeks
Secondary outcomes (1)
blood flow
blood flow by ultrasound
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start13 Dec 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Haus, University of Michigan
- Investigators
- Jacob Haus, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603273
- Sponsor's protocol ID
- HUM00202034
- Other IDs
- P30DK020572
- Status last verified
- Jul 2026
- First submitted
- 26 Oct 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share data at this time
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT05603273
- Acronym / sponsor ID
- HUM00202034
- Conditions
- Type2diabetes, Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| standard wound care | No intervention | –normal wound care according to current clinical practice |
| non-weight bearing exercise + standard wound care | Experimental | Behavioral: non-weight bearing exercisenormal wound care according to current clinical practice with the addition of a weekly exercise routine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or Female, aged 18 yrs or older
- Diabetes diagnosed or meets ADA criteria for Type 2 diabetes
- Foot ulcer of diabetic etiology, with all of the following characteristics:
Key exclusion criteria (13 listed)
- Patient participating in an interventional clinical trial within 1 month of visit 1
- Participant has Charcot's foot or other foot deformities that prevent adequate targeted ulcer offloading
- Participant has active severe infection or osteomyelitis at the time of the screening visit
- History of cancer within the last 3 years, other than non-melanoma skin cancer
- Use of adjunctive therapy within previous 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-weight bearing exerciseexercise on a non-weight bearing device at 50% of peak capacity, 3 days per week for 6 weeks | Behavioural | non-weight bearing exercise + standard wound care |
Primary outcome
wound size and depth
Time frame: 6 weeks
wound site and depth
1 secondary outcome
blood flow
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. no plan to share data at this time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Haus, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-weight bearing exercise in people with Type2diabetes and Foot Ulcer, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound size and depth (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.