Non-weight Bearing Exercise for Diabetic Foot Ulcers

Overseen By Jacob Haus, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Systemic glucocorticoids

Disqualifiers: Charcot's foot, Severe infection, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether non-weight bearing exercise can heal diabetic foot ulcers faster than regular wound care alone. Researchers aim to determine if this exercise can improve blood flow to the ulcer and boost metabolism. Participants will be divided into two groups: one will receive standard wound care, and the other will receive both standard care and a special exercise routine. This trial suits individuals with diabetes who have a foot ulcer, no serious infections, and are cleared for exercise. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance diabetic foot ulcer treatments.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently receiving systemic glucocorticoids or have used adjunctive therapy in the past 30 days.

What prior data suggests that non-weight bearing exercise is safe for individuals with diabetic foot ulcers?

Research has shown that non-weight bearing exercise is generally safe for individuals with diabetic foot ulcers. One study found this exercise safe for people with diabetes, including those with severe nerve damage and foot ulcers, with only minor side effects like mild discomfort reported.

Another study supports that specific exercises can be safely performed during and after a hospital stay for patients with diabetes-related foot ulcers. Although human data is limited, exercise appears promising for aiding wound healing without major risks. Therefore, participants in trials like this one can feel confident about the safety of the exercise program being tested. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about non-weight bearing exercise for diabetic foot ulcers because it offers a new approach to managing this condition. Unlike traditional treatments that focus solely on wound care, this method incorporates a weekly exercise routine without stressing the affected foot. This approach aims to promote healing by improving circulation and reducing pressure on the ulcer, potentially speeding up recovery and reducing complications.

What evidence suggests that non-weight bearing exercise is effective for diabetic foot ulcers?

Research has shown that exercises not putting weight on the feet might aid in healing foot wounds in people with diabetes. In this trial, participants will receive either standard wound care or standard wound care combined with a non-weight-bearing exercise routine. Some studies on animals and a few on humans have suggested that exercise can aid wound healing, but the evidence remains inconclusive. Exercise is considered safe for individuals with these foot wounds, even in a hospital setting. Being active can also reduce the risk of developing diabetes-related foot problems. However, more research is needed to fully understand how exercise aids in healing these wounds. ^{2 3 6 7 8}

Who Is on the Research Team?

Jacob Haus, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Type 2 diabetes and a diabetic foot ulcer between 0.5cm² and 12cm², not complicated by infection or severe conditions. Participants must be able to exercise safely, have no recent vascular interventions, and not be on systemic glucocorticoids or involved in other trials.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study

I have been diagnosed with Type 2 diabetes.

I have a diabetic foot ulcer between 0.5cm2 and 12cm2, not close to other ulcers, and it's graded Wagner 1 or 2.

Exclusion Criteria

I have not had any cancer except for non-melanoma skin cancer in the past 3 years.

I have wounds or ulcers on both sides of my body.

Your blood sugar levels are not well controlled and you have ketones in your urine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants are randomized to either non-weight bearing exercise + standard wound care or standard wound care alone for 6 weeks

6 weeks

3 visits per week (in-person) for exercise group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Non-weight Bearing Exercise

Trial Overview The study tests if non-weight bearing exercises can speed up healing of diabetic foot ulcers compared to standard care alone. Over six weeks, participants will either perform these exercises along with receiving standard wound care or just receive the standard care.

How Is the Trial Designed?

Group I: non-weight bearing exercise + standard wound care Experimental Treatment 1 Intervention

normal wound care according to current clinical practice with the addition of a weekly exercise routine

Group II: standard wound care Active Control 1 Intervention

normal wound care according to current clinical practice

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

A 12-month randomized controlled trial with 79 participants showed that a lower-extremity exercise and walking program increased bout-related daily steps by 14% in individuals with diabetic peripheral neuropathy, while the control group saw a decrease in steps.

Importantly, promoting weight-bearing activity did not result in a significant increase in foot ulcers, suggesting that such activities can be safely recommended for patients with diabetic peripheral neuropathy after proper assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of weight-bearing activity on foot ulcer incidence in people with diabetic peripheral neuropathy: feet first randomized controlled trial. Lemaster, JW., Mueller, MJ., Reiber, GE., et al.[2022]

A new device, the CLEAR Cleat, significantly reduces peak pressure and contact area on the forefoot while cycling, which is crucial for individuals with active neuropathic diabetic foot wounds.

The study involved 10 healthy participants and demonstrated that using an off-loading insole with a specialized cleat resulted in lower pressure values compared to standard cycling conditions, suggesting potential for safer exercise in at-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CLEAR Cleat: a proof-of-concept trial of an aerobic activity facilitator to reduce plantar forefoot pressures and their potential in those with foot ulcers. Klein, EE., Crews, RT., Wu, SC., et al.[2019]

A tailored exercise program for adults with diabetes-related foot ulcers was found to be safe, with no adverse events reported during the study involving 20 participants.

The program showed high retention (95%) and acceptable adherence rates, indicating that patients can successfully engage in supervised and home exercises while managing their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in adults admitted to hospital with diabetes-related foot ulcers: a pilot study of feasibility and safety. Aitken, E., Hiew, J., Hamilton, EJ., et al.[2023]

People with diabetes-related foot disease generally take similar daily steps regardless of their risk level for foot ulcers, but those with an active ulcer average significantly fewer steps (4248 steps/day).

Activity levels are influenced by climate, with individuals in temperate oceanic climates being more active than those in hotter or more humid areas, and people tend to be more active indoors (mean 4047 steps) compared to outdoors (mean 2514 steps).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight-bearing physical activity in people with diabetes-related foot disease: A systematic review. van Netten, JJ., Fijen, VM., Bus, SA.[2022]

Individuals at risk of diabetic foot ulcers face unique challenges that can hinder their ability to increase physical activity, including concerns about pain, depression, and self-efficacy.

Despite these challenges, physical activity is not contraindicated for at-risk patients, and the review provides recommendations for safely implementing exercise interventions to help reduce the risk of foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological and psychological challenges of increasing physical activity and exercise in patients at risk of diabetic foot ulcers: a critical review. Crews, RT., Schneider, KL., Yalla, SV., et al.[2018]

A 10-week non-weightbearing exercise program for five men with severe peripheral neuropathy and diabetic foot ulcers was found to be feasible and safe, with high attendance (85-95%) and satisfaction ratings (≥9/10).

All participants experienced significant healing of their foot ulcers, with size reductions from a median of 1.9 cm² to 0.0 cm², and improvements in physical capabilities, including increased distance on a stationary bike and enhanced muscle strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exercise program for people with severe peripheral neuropathy and diabetic foot ulcers - a case series on feasibility and safety. Lindberg, K., Møller, BS., Kirketerp-Møller, K., et al.[2021]

In a study comparing Native Americans with diabetes, no significant differences were found in plantar pressure or skin hardness between those with and without foot sensation who engaged in regular weight-bearing activities, suggesting that these factors may not directly influence the risk of diabetic foot ulcers.

The findings indicate a need for further research with larger sample sizes and more reliable measurement tools to better understand the relationship between weight-bearing activities and diabetic foot ulcer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight-bearing activity and foot parameters in Native Americans with diabetes with and without foot sensation. Cuaderes, E., Lamb, L., Khan, M., et al.[2010]

In a study involving 15 participants with diabetes and peripheral neuropathy, peak plantar pressures (PPP) during various weight-bearing (WB) and non-weight-bearing (NWB) exercises were compared, revealing that most exercises did not significantly increase injury risk compared to level walking.

While treadmill walking showed a 13% increase in forefoot PPP, this was not significant when accounting for walking speed; however, caution is advised during heel raises due to higher PPP, suggesting a need for careful monitoring and gradual progression in exercise intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of selected exercises on in-shoe plantar pressures in people with diabetes and peripheral neuropathy. Shah, KM., Mueller, MJ.[2022]

Citations

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Does exercise improve healing of diabetic foot ulcers? ... This systematic review found there is insufficient evidence to conclusively support non-weight bearing exercise as an intervention to improve healing of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S149926712500022X

A Systematic Review of Glycemia, Fitness, and Wound ... Exercise may improve wound healing in people with diabetes-related foot ulcers, based on animal studies and limited human data. •. Physical activity guidelines ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06092827

Feasibility and Acceptability of Non Weight-bearing ... Data collection at 24 and 36 weeks is also planned for participants who agree to be contacted after completing the 12-week PA program. Official Title.

4. jfootankleres.biomedcentral.com jfootankleres.biomedcentral.com/articles/10.1186/s13047-023-00616-0

Exercise in adults admitted to hospital with diabetes-related ... Targeted exercise appears safe to be undertaken by patients with diabetes-related foot ulcers during and after an acute hospital admission.

5. mdpi.com mdpi.com/2227-9059/13/7/1752

On the Merits of Targeted and Individualized Physical ... Meanwhile, physical activity (PA) has been shown to reduce the risk of developing DFD through various mechanisms, and emerging evidence also supports the role ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10043540/

Exercise in adults admitted to hospital with diabetes ... Targeted exercise appears safe to be undertaken by patients with diabetes-related foot ulcers during and after an acute hospital admission.

7. withpower.com withpower.com/trial/phase-diabetic-foot-10-2023-d9f3b

Non Weight-bearing Physical Activity for Diabetic Foot ... A non-weightbearing exercise program for people with diabetes, severe peripheral neuropathy, and foot ulcers appears to be safe, with only minor adverse events ...

8. jfootankleres.biomedcentral.com jfootankleres.biomedcentral.com/articles/10.1186/s13047-021-00456-w

Does exercise improve healing of diabetic foot ulcers? A ... This systematic review found there is insufficient evidence to conclusively support non-weight bearing exercise as an intervention to improve healing of ...