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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Non-weight Bearing Exercise for Diabetic Foot Ulcers is an effective treatment?

The available research shows that Non-weight Bearing Exercise can be a safe and effective treatment for diabetic foot ulcers. In a study where participants with severe peripheral neuropathy and diabetic foot ulcers engaged in a 10-week exercise program, all participants completed the program with high satisfaction and minimal adverse events. The ulcers reduced in size for all participants, and their ability to perform daily activities improved. This suggests that Non-weight Bearing Exercise can help in healing ulcers and improving quality of life for those affected. ^{1 2 3 4 5}

What safety data exists for non-weight bearing exercise in treating diabetic foot ulcers?

A case series study examined a non-weight bearing exercise program for individuals with severe peripheral neuropathy and diabetic foot ulcers, finding it feasible and safe. Participants showed high adherence and satisfaction, with only minor adverse events reported. Ulcers reduced in size, and improvements were noted in muscle strength and daily living activities. Further studies are recommended to confirm these findings. ^{2 5 6 7 8}

Is Non-weight Bearing Exercise a promising treatment for Diabetic Foot Ulcers?

Yes, Non-weight Bearing Exercise is a promising treatment for Diabetic Foot Ulcers. It has been shown to be safe and effective, with participants experiencing reduced ulcer size, improved muscle strength, and better ability to perform daily activities. The exercise program was well-received, with high satisfaction and good attendance. ^{2 3 4 5 6}

Research Team

Jacob Haus, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

References

1. England 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. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Exercise in adults admitted to hospital with diabetes-related foot ulcers: a pilot study of feasibility and safety. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Weight-bearing physical activity in people with diabetes-related foot disease: A systematic review. [2022]

4. United States 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. [2019]

5. England 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Weight-bearing activity and foot parameters in Native Americans with diabetes with and without foot sensation. [2010]

7. Scotland pubmed.ncbi.nlm.nih.gov

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

8. United States 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. [2022]