Orthotic Treatment for Diabetic Foot Ulcers

Overseen By Muturi G Muriuki, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Amputation, Severe infection, Non-ambulatory, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 months

175 Participants Needed

Trial Summary

What is the purpose of this trial?

The United States Department of Veterans Affairs spends an estimated $1.5 billion a year on healthcare for patients with diabetes. The prevalence and complications of diabetes increase with age. Therefore, with the aging of the US and Veteran populations, there is an expectation of increased healthcare costs associated with treating diabetes and the associated complications of this disorder. One common complication is the diabetic foot ulcer. Diabetic foot ulcers are expensive to treat, can take a long time to heal and result in a decrease in patient quality of life. Patients remain susceptible to developing more foot ulcers over time. The goal of this project is to reduce the time it takes to heal a diabetic foot ulcer, increase the time between episodes of ulceration and improve the quality of life for diabetic foot ulcer patients.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment for diabetic foot ulcers?

Research shows that using removable cast walkers (a type of orthopedic boot) can help heal diabetic foot ulcers by reducing pressure on the foot. This treatment is recommended by experts and has been shown to be effective in several studies. ^{1 2 3 4 5}

Is the orthotic treatment for diabetic foot ulcers safe?

Wearing a controlled ankle movement (CAM) walker boot can cause leg length differences, which might lead to balance issues and joint discomfort. However, using a leg length-evening device can help improve balance and reduce discomfort. ^{1 4 6 7 8}

How is the removable cam walker boot treatment different from other treatments for diabetic foot ulcers?

The removable cam walker boot is unique because it allows patients to remain mobile while reducing pressure on the ulcer, unlike traditional methods like total contact casting which often require immobility. This boot is designed to be removable, making it more convenient for patients compared to nonremovable casts. ^{1 3 5 8 9}

Research Team

Muturi G. Muriuki, PhD

Principal Investigator

Edward Hines Jr. VA Hospital, Hines, IL

Eligibility Criteria

This trial is for veteran patients with diabetic foot ulcers who are prescribed an orthotic walking boot. Participants must be able to understand instructions (with a BIMS score above 7), have palpable pedal pulses, and be ambulatory. Those with severe cognitive impairment, serious infections, amputations above the ankle, or very advanced ulcers (Meggitt-Wagner score of 4+) cannot join.

Inclusion Criteria

Veterans who are using a special walking boot for their diabetic foot ulcer can join the study.

Exclusion Criteria

All patients will be screened for severe cognitive impairment with the 15 point Brief Interview for Mental Status (BIMS)

I am a veteran with a detectable pulse in my feet.

I am a veteran, but my wound severity score is less than 4.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orthotic treatment and counseling to manage diabetic foot ulcers

8 months

At each clinic visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Counseling
• Removable cam walker boot

Trial Overview The study is testing whether using a removable cam walker boot and providing counseling can reduce healing time for diabetic foot ulcers, prevent future ulcers, and improve quality of life compared to standard care alone in veterans.

Participant Groups

Group I: Treatment group Experimental Treatment 2 Interventions

Patients will be given additional counseling

Group II: Control group Active Control 1 Intervention

Patients will be given standard of care.

Removable cam walker boot is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Removable Cam Walker Boot for:

• Diabetic foot ulcers
• Foot injuries
• Post-surgical recovery

Approved in European Union as Removable Cam Walker Boot for:

• Diabetic foot ulcers
• Foot injuries
• Post-surgical recovery

Approved in Canada as Removable Cam Walker Boot for:

• Diabetic foot ulcers
• Foot injuries
• Post-surgical recovery

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Total contact casting and irremovable cast walkers significantly improve healing rates of diabetic neuropathic foot ulcers compared to removable cast walkers, based on a systematic review of 13 randomized controlled trials involving patients without severe peripheral arterial disease.

Economic analysis indicates that total contact casting and irremovable cast walkers are more cost-effective than removable cast walkers, potentially leading to cost savings for healthcare systems due to reduced amputation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fibreglass Total Contact Casting, Removable Cast Walkers, and Irremovable Cast Walkers to Treat Diabetic Neuropathic Foot Ulcers: A Health Technology Assessment. [2022]

The study involving 25 individuals at risk for diabetic foot ulcers found that ankle-high removable cast walkers (RCWs) combined with a contralateral limb lift improved comfort and gait, which may enhance patient adherence to offloading treatments.

While knee-high RCWs provided better offloading of the foot, they were less comfortable and resulted in slower walking speeds, suggesting that comfort is crucial for encouraging patients to consistently use offloading devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreasing an Offloading Device's Size and Offsetting Its Imposed Limb-Length Discrepancy Lead to Improved Comfort and Gait. Crews, RT., Candela, J.[2019]

In a study of 93 patients with diabetic plantar ulcers, a nonremovable fiberglass cast boot led to a significantly higher healing rate (81%) compared to off-loading shoes (70%), with much shorter healing times (68.6 days vs. 134.2 days).

The cast boot also resulted in better treatment compliance (98% vs. 10%) and a lower incidence of secondary osteomyelitis (3 cases vs. 13 cases), highlighting its effectiveness and safety in managing diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonremovable, windowed, fiberglass cast boot in the treatment of diabetic plantar ulcers: efficacy, safety, and compliance. Ha Van, G., Siney, H., Hartmann-Heurtier, A., et al.[2022]

In a study involving 16 participants with diabetes-related foot ulcers, the removable cast walker (RCW) with felt adhered directly to the foot resulted in an impressive 83.1% reduction in peak plantar pressure, significantly more than other conditions tested.

The RCW with felt adhered to the foot was more effective than both the RCW alone and the RCW with felt on an orthosis, indicating that modifications to the RCW can enhance its offloading capabilities for better management of foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Offloading effects of a removable cast walker with and without modification for diabetes-related foot ulceration: a plantar pressure study. Withers, RV., Perrin, BM., Landorf, KB., et al.[2023]

In a study of 45 adult diabetic patients with plantar foot ulcers, both the removable Stabil-D cast walker and the nonremovable total contact cast (TCC) were equally effective in reducing ulcer size and achieving healing, with no significant differences in outcomes.

The average healing time was similar for both groups, suggesting that the more user-friendly Stabil-D cast walker could encourage better adherence to treatment for managing diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of removable walker cast versus nonremovable fiberglass off-bearing cast in the healing of diabetic plantar foot ulcer: a randomized controlled trial. Faglia, E., Caravaggi, C., Clerici, G., et al.[2022]

In a study of 46 patients wearing CAM walker boots for an average of 4.2 weeks, 67% reported new or worsened pain at secondary sites, particularly in the lower back, contralateral hip, and ipsilateral knee.

While the frequency and severity of secondary site pain decreased after transitioning out of the boot, about one-third of patients still experienced pain three months later, indicating a need for awareness and management of this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associated Joint Pain With Controlled Ankle Movement Walker Boot Wear. Ready, LV., Fisk, EG., Ciurylo, W., et al.[2022]

A study involving 107 patients in a controlled ankle motion (CAM) boot showed that using a leg length-evening orthotic significantly improved balance compared to those wearing normal shoes, with reported balance difficulties of 2.0 vs 3.2 on a scale of 0 to 10.

Despite the improvement in balance, there were no significant differences in pain levels at the knees, hips, or back between the two groups, indicating that the orthotic primarily benefits balance without affecting pain outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Leg Length-Evening Device on Perceived Balance in Patients Wearing a Controlled Ankle Motion Boot. Mehraban, N., Idarraga, AJ., Wu, KJ., et al.[2022]

In a study involving 21 patients with Charcot arthropathy, 68% of the treated feet and ankles showed successful consolidation after using a prefabricated, pneumatic removable walker brace for an average of 29 weeks.

The walker brace demonstrated a high satisfaction rate and a good safety profile, with only minor complications reported, indicating it is an effective management option for Charcot foot and ankle conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Charcot foot and ankle with a prefabricated removable walker brace and custom insole. Verity, S., Sochocki, M., Embil, JM., et al.[2008]

A boot cast, designed specifically for diabetic patients with neuropathic foot ulcers, was tested on 14 patients with 16 ulcers, showing that it can effectively promote healing even for ulcers that had been present for an average of 912 days.

The boot cast allowed for 100% healing of ulcers within 130 days and has maintained a mean recurrence-free period of 218 days, enabling patients to stay mobile while reducing the risk of amputation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of neuropathic ulceration. McGill, M., Collins, P., Bolton, T., et al.[2018]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Fibreglass Total Contact Casting, Removable Cast Walkers, and Irremovable Cast Walkers to Treat Diabetic Neuropathic Foot Ulcers: A Health Technology Assessment. [2022]

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

Decreasing an Offloading Device's Size and Offsetting Its Imposed Limb-Length Discrepancy Lead to Improved Comfort and Gait. [2019]

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

Nonremovable, windowed, fiberglass cast boot in the treatment of diabetic plantar ulcers: efficacy, safety, and compliance. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Offloading effects of a removable cast walker with and without modification for diabetes-related foot ulceration: a plantar pressure study. [2023]

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

Effectiveness of removable walker cast versus nonremovable fiberglass off-bearing cast in the healing of diabetic plantar foot ulcer: a randomized controlled trial. [2022]

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

Associated Joint Pain With Controlled Ankle Movement Walker Boot Wear. [2022]

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

Effect of Leg Length-Evening Device on Perceived Balance in Patients Wearing a Controlled Ankle Motion Boot. [2022]

8. France pubmed.ncbi.nlm.nih.gov

Treatment of Charcot foot and ankle with a prefabricated removable walker brace and custom insole. [2008]

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

Management of neuropathic ulceration. [2018]