At-Home Exercise for Diabetic Foot Ulcers

Overseen By Frederick M Ivey, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Current foot ulcer, Foot surgery, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a home-based exercise plan can help individuals with diabetes who have had foot ulcers improve mobility without causing new ulcers. Participants will either follow a special exercise routine or receive standard care advice on gradually increasing activity. The trial aims to determine if regular exercise can boost leg strength and blood flow while managing blood sugar levels. It may suit individuals over 50 with diabetes who have had foot ulcers or minor amputations and can exercise without needing a walker. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance diabetes care and improve quality of life.

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

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this home-based exercise regimen is safe for people with diabetic foot ulcers?

Research shows that exercise can safely aid individuals with healed diabetic foot ulcers. One study found that a 12-week exercise program improved flexibility and muscle strength in patients with diabetic foot issues, with few safety concerns. Another review suggests that exercise might aid wound healing in people with diabetes, although most evidence comes from animal studies, with limited human data.

In past cases, exercise programs have not caused major side effects in similar groups. These findings suggest that exercise is generally well-tolerated and might benefit people with diabetic foot ulcers. However, individuals should consider their health needs and consult healthcare providers before starting any new exercise routine. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the at-home exercise program for diabetic foot ulcers because it offers a proactive, holistic approach that empowers patients to manage their condition in the comfort of their own homes. Unlike the standard of care, which typically involves gradually increasing walking with proper footwear, this program incorporates a structured exercise regimen. It blends seated cycling and strength/balance exercises five days a week, which could enhance circulation and promote healing more effectively. This innovative approach could lead to better outcomes by actively engaging patients, improving mobility, and potentially speeding up ulcer healing.

What evidence suggests that this home-based exercise regimen is effective for diabetic foot ulcers?

This trial will compare a 12-week home-based exercise program with the standard of care for individuals with healed diabetic foot ulcers. Research has shown that a 12-week home exercise program may help individuals with healed diabetic foot ulcers improve mobility and function. Previous studies found that similar exercise routines can lower blood sugar levels, which is crucial for managing diabetes. These programs also enhance muscle strength and flexibility, essential for maintaining mobility. Participants can perform the exercises at home, making them easy and convenient to incorporate into daily routines. Early evidence suggests these programs do not increase the risk of recurring foot ulcers, which is important for long-term health. ^{1 3 4 5 6}

Who Is on the Research Team?

Mary-Claire Roghmann, MD

Principal Investigator

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Are You a Good Fit for This Trial?

This trial is for veterans who have had diabetic foot ulcers that are now healed. Participants should be able to perform exercises at home and must not currently have any active foot ulcers or infections.

Inclusion Criteria

I have both of my feet, minor amputations allowed.

I can walk without the help of a front wheel walker.

I am 50 years old or older.

Exclusion Criteria

Unable to perform the exercise interventions (e.g. due to hearing or visual impairment)

Any other criteria which, in the investigator's opinion, would compromise the ability of a subject to participate safely

Participating in another exercise program

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week home-based exercise regimen or receive standard care

12 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 12-week home based exercise

Trial Overview The study is testing a 12-week home-based exercise program against the standard care which involves slowly increasing walking. The goal is to see if exercising at home can improve mobility and health without causing foot ulcers to come back.

How Is the Trial Designed?

Group I: 12-week home based exercise Experimental Treatment 1 Intervention

Consistent with current physical activity recommendations for older adults, participants randomized in this arm will be prescribed 5 days/week of exercise, with seated cycling exercise performed on 3 days a week (Monday, Wednesday and Friday), and strength/balance exercise performed 2 days a week (Tuesday and Thursday).

Group II: 12-week standard of care Placebo Group 1 Intervention

Participants in this group will be provided with guidance on the current standard of care. This includes guidance that these patients should slowly increase ambulation with appropriately fitted footwear.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12504896/

Home-Based Exercise to Improve Functional Outcomes in ... This pilot study will assess the feasibility and acceptability of a home-based exercise regimen aimed at safely increasing mobility and function ...

2. nature.com nature.com/articles/s41598-024-78188-7

Effectiveness of a web-based foot-ankle exercise program ... While DPN-related outcomes were unaffected by the 12-week SOPeD program, modest improvements in foot pain and function, functional reach, and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0897189725000138

Effects of a 12-week lower limb resistance training with ... This 12-week training program effectively reduced fasting blood glucose and HbA1c levels and enhanced the quality of life for the participants.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06312579

At-Home Exercise Study for Veterans With Healed Diabetic ... The investigators will also assess if this home-based exercise regimen can increase mobility and function without increasing diabetic foot ulcer recurrence by ...

5. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2022.869128/full

Effects of a 12-Week Interventional Exercise Programme ... Our 12-week interventional exercise programme proved relatively safe, resulting in improved body flexibility and increased muscle strength in DF patients in ...

6. 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 ...