Non Weight-bearing Physical Activity for Diabetic Foot

(DB-ACTIV Trial)

Overseen By Magali Brousseau-Foley, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université du Québec à Trois-Rivières

Disqualifiers: Uncontrolled DFU infection, Uncontrolled hyperglycemia, Recent cardiovascular event, Recent neurovascular problem, Diabetes complication, others

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

Compensation: Varies

Number of Visits: 26

Duration: 12 weeks

12 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Non Weight-bearing Physical Activity Program treatment for diabetic foot?

Research suggests that non-weight-bearing exercises can help improve joint mobility and blood flow, which may aid in the healing of diabetic foot wounds. A study found that a foot-ankle exercise program improved foot strength and reduced symptoms in people with diabetic neuropathy, indicating potential benefits for diabetic foot care. ^{1 2 3 4 5}

Is non-weightbearing physical activity safe for people with 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 reported and improvements in foot ulcer healing and physical abilities. Precautions should be taken to ensure safety, especially considering individual health conditions. ^{1 6 7 8 9}

How does the Non Weight-bearing Physical Activity Program differ from other treatments for diabetic foot?

The Non Weight-bearing Physical Activity Program is unique because it focuses on exercises that do not put pressure on the feet, making it safer for people with diabetic foot ulcers and severe peripheral neuropathy. This approach helps improve muscle strength and daily living activities without compromising the healing of foot ulcers, unlike traditional weight-bearing exercises. ^{1 3 7 8 10}

What is the purpose of this trial?

Intervention in the form of a PA (physical activity) program combining aerobic, resistance, and flexibility exercises adapted for wearing a lower limb offloading device and limiting weight-bearing on the feet, with a duration of twelve (12) weeks, consisting of two supervised sessions and one unsupervised home session per week.

Research Team

Magali Brousseau-Foley, MD

Principal Investigator

Université du Québec à Trois-Rivières

Eligibility Criteria

This trial is for people aged 18-75 with diabetic foot ulcers who are willing to do physical activity while wearing a device that keeps weight off their feet. They must follow wound care advice and have stable blood sugar levels. It's not for those who already do intense workouts twice a week, have recent serious heart issues, uncontrolled high blood pressure, or an untreated foot ulcer infection.

Inclusion Criteria

You engage in sports or strenuous physical activities at least twice per week.

I have not had a heart attack or heart surgery in the last 3 months and do not have uncontrolled high blood pressure or unmanaged heart failure.

You are amenable to participating in physical activities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a non-weight bearing physical activity program combining aerobic, resistance, and flexibility exercises for 12 weeks

12 weeks

2 supervised sessions and 1 unsupervised home session per week

Follow-up

Participants are monitored for safety and effectiveness after the 12-week physical activity program

12 weeks

Data collection at 24 and 36 weeks for consenting participants

Treatment Details

Interventions

• Non Weight-bearing Physical Activity Program

Trial Overview The study tests a 12-week non weight-bearing physical activity program designed for people with diabetic foot ulcers. Participants will perform aerobic, resistance, and flexibility exercises during two supervised sessions and one at home each week without putting weight on their feet.

Participant Groups

Group I: Physical activity Experimental Treatment 1 Intervention

Adults 18 to 75 with an active diabetic foot ulcer

Who Is Running the Clinical Trial?

Université du Québec à Trois-Rivières

Lead Sponsor

Trials

48

Recruited

4,500+

Université de Montréal

Collaborator

Trials

223

Recruited

104,000+

Fondation Santé Trois-Rivières

Collaborator

Trials

1

Recruited

10+

Centre intégré universitaire de santé et services sociaux Mauricie et Centre-du-Québec (CIUSSS MCQ)

Collaborator

Trials

1

Recruited

10+

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]

Physical activity is crucial for diabetes management, providing benefits like improved blood sugar control, reduced risk of related health issues, and enhanced quality of life for patients with both type 1 and type 2 diabetes.

Caregivers often lack knowledge about exercise recommendations for diabetic patients, which can lead to either unnecessary restrictions on physical activity or increased risk of adverse reactions; therefore, proper assessment of health conditions and safety measures is essential before starting an exercise program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercise prescription for diabetics: more than a general recommendation]. Constantini, N., Harman-Boehm, I., Dubnov, G.[2008]

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 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]

Physical activity is crucial for preventing and managing type 2 diabetes and cardiovascular risks, but individuals with diabetes face higher risks of injury during exercise due to complications associated with the disease.

To ensure safe exercise for people with type 2 diabetes, it is important to tailor exercise programs to individual health conditions and complications, such as diabetic foot and retinopathy, while implementing preventative measures to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of exercise-related injuries and adverse events in patients with type 2 diabetes. Mendes, R., Sousa, N., Reis, VM., et al.[2013]

References

1. China pubmed.ncbi.nlm.nih.gov

[Summary of the best evidence on exercise for the prevention and treatment of diabetic foot]. [2023]

2. 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]

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

The effect of nonweight-bearing exercise and protocol adherence on diabetic foot ulcer healing: a pilot study. [2010]

4. 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]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Preliminary Efficacy of a Foot-Ankle Exercise Program Aiming to Improve Foot-Ankle Functionality and Gait Biomechanics in People with Diabetic Neuropathy: A Randomized Controlled Trial. [2021]

6. Israel pubmed.ncbi.nlm.nih.gov

[Exercise prescription for diabetics: more than a general recommendation]. [2008]

7. 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]

8. Scotland pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Prevention of exercise-related injuries and adverse events in patients with type 2 diabetes. [2013]

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]