At-Home Exercise for Diabetic Foot Ulcers

Overseen By Frederick M Ivey, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: VA Office of Research and Development

Disqualifiers: Current foot ulcer, Foot surgery, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment 12-week home based exercise for diabetic foot ulcers?

Research shows that exercise therapy, including foot exercises, can help improve wound healing in diabetic foot ulcers by enhancing blood sugar control and insulin sensitivity. A 12-week exercise program combining aerobic and resistance training was found to be feasible and relevant for patients, although more studies are needed to confirm its effectiveness. ^{1 2 3 4 5}

Is at-home exercise safe for people with diabetic foot ulcers?

Research suggests that exercise programs, especially non-weightbearing ones, are generally safe for people with diabetic foot ulcers, as they do not compromise ulcer healing and have only minor adverse events. Participants in studies have shown high satisfaction and improved physical abilities. ^{4 6 7 8 9}

How does the at-home exercise treatment for diabetic foot ulcers differ from other treatments?

The at-home exercise treatment for diabetic foot ulcers is unique because it focuses on a non-weightbearing exercise program that can be safely done at home, which is different from traditional treatments that often emphasize rest and offloading pressure from the foot. This approach not only helps in healing the ulcers but also improves muscle strength and daily activity performance, offering a more active recovery option for patients. ^{4 6 7 10 11}

What is the purpose of this trial?

Foot ulcers and amputations are a common and feared complication for people with diabetes. People with a diabetic foot ulcer have a higher risk of dying within five years than people with diabetes without an ulcer. At least one in four people with a new diabetic foot ulcer will die within five years, largely due to cardiovascular causes. The reasons for this increased mortality involve decreased mobility. People with a recently healed diabetic foot ulcer are considered "in remission" as opposed to "cured" because the underlying medical problems which led to their ulcer are still present. Once in remission, the current standard of care is to slowly increase ambulation. The problem is that people rarely return to the recommended level of mobility. The ability to safely maintain mobility with aging is critical. This pilot study is a small clinical trial to test the feasibility and acceptability of a home-based exercise regimen. The investigators will also assess if this home-based exercise regimen can increase mobility and function without increasing diabetic foot ulcer recurrence by improving lower extremity strength, lower extremity tissue perfusion and glycemic control.

Research Team

Mary-Claire Roghmann, MD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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 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]

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]

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]

References

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

The Effect of Foot Exercises on Wound Healing in Type 2 Diabetic Patients With a Foot Ulcer: A Randomized Control Study. [2022]

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

A 12-Week Supervised Exercise Therapy Program for Patients with Diabetic Foot Ulcers: Program Development and Preliminary Feasibility. [2023]

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

Reporting standards of studies and papers on the prevention and management of foot ulcers in diabetes: required details and markers of good quality. [2022]

4. 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]

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

Effect of foot-ankle flexibility and resistance exercise in the secondary prevention of plantar foot diabetic ulcer. [2022]

6. 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]

7. 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]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of New Technological Opportunities and the Need to Evaluate the Activities Performed in the Prevention of Diabetic Foot with Exercise Therapy. [2021]

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

Remaining Question: Does Exercise Improve Healing of Diabetic Foot Ulcers? [2023]

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

Effects of weight-bearing exercise on a mini-trampoline on foot mobility, plantar pressure and sensation of diabetic neuropathic feet; a preliminary study. [2022]

11. 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]