Non Weight-bearing Physical Activity for Diabetic Foot

(DB-ACTIV Trial)

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Non Weight-bearing Physical Activity Program can aid in healing diabetic foot ulcers. The program includes exercises that avoid putting weight on the feet, such as certain aerobics and strength training, and is tailored for individuals using a device to offload weight from their lower limbs. It is suitable for those with an active diabetic foot ulcer who can commit to a 12-week exercise plan and adhere to wound care guidance. Participants should not have uncontrolled infections or blood sugar issues and should not already engage in intense exercise. As an unphased trial, this study provides a unique opportunity to explore innovative exercise solutions for diabetic foot ulcers.

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 prior data suggests that this physical activity program is safe for individuals with diabetic foot ulcers?

Research shows that exercise is generally safe for people with diabetes-related foot ulcers. One study demonstrated that patients with these ulcers could safely perform specific exercises during and after their hospital stay. Another study found that non-weight-bearing exercises, which don't put pressure on the feet, are safe for individuals with simple foot ulcers, provided a doctor approves them.

Although human data is limited, animal studies suggest that exercise might accelerate wound healing in people with diabetes. Importantly, newer evidence indicates that activities like standing or walking, which involve weight-bearing, do not increase the risk of developing foot ulcers.

Overall, exercises in the non-weight-bearing activity program appear well-tolerated and safe for people with diabetic foot ulcers. Always consult a doctor to ensure it's appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Non Weight-bearing Physical Activity Program for diabetic foot ulcers because it offers a new approach to healing these challenging wounds. Unlike traditional treatments that often focus on wound care and pressure offloading through methods like specialized footwear or surgery, this program emphasizes engaging in physical activities that don't put weight on the feet. This approach could potentially enhance blood flow and promote healing without increasing stress on the ulcer. By exploring how non weight-bearing activity can aid recovery, researchers hope to discover a complementary strategy to improve outcomes for patients with diabetic foot ulcers.

What evidence suggests that this non weight-bearing physical activity program is effective for diabetic foot?

Research has shown that exercise can aid people with diabetic foot ulcers by improving health factors and reducing foot pain. One study found that specific exercises are safe for individuals with these ulcers, even during hospitalization. Although strong evidence is lacking that non-weight-bearing exercises accelerate healing, exercise does enhance overall fitness and health in people with diabetes, including better blood sugar control and stronger muscles. In this trial, participants will engage in a Non Weight-bearing Physical Activity Program, designed to offer these benefits without stressing the feet, making it particularly beneficial for those with foot ulcers. ^{2 3 6 7 8}

Who Is on the Research Team?

Magali Brousseau-Foley, MD

Principal Investigator

Université du Québec à Trois-Rivières

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05603273

Non-weight Bearing Exercise for Accelerated Healing of ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7980337/

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

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

A Systematic Review of Glycemia, Fitness, and Wound ... In this study we examined the effects of regular exercise (training) on glycemia, cardiorespiratory fitness, muscular strength, metabolic health, and ulcer ...

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

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

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/15347346251356862

Exercise in Diabetic Foot Ulceration. A Brief Narrative Review Data show that exercise provides stage-specific benefits in DFUs by improving risk factors, reducing plantar pressures and foot pain prior to ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06092827

Feasibility and Acceptability of Non Weight-bearing ... For individuals with a diabetic foot ulcer: Inclusion: Male or female; Aged over 18 up to 75 years; Willing to engage in PA (physical activity); Committed to ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11494447/

Protective effect of regular physical activity against ... However, since 2008, new evidence has suggested that weight‐bearing activities do not increase the incidence of foot ulcers. This finding ...