Orthotic Treatment for Diabetic Foot Ulcers

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with diabetic foot ulcers heal faster and improve their quality of life. Researchers are testing whether a removable cam walker boot (a type of orthopedic boot), combined with extra counseling, can speed up healing and reduce the recurrence of ulcers. Veterans with diabetes who currently use an orthotic walking boot for a foot ulcer might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance treatment options 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.

What prior data suggests that this orthotic treatment is safe for diabetic foot ulcers?

Research has shown that removable cam walker boots are generally safe for people with diabetic foot ulcers. These boots help patients stay active while reducing pressure on the ulcer, aiding healing. Although studies indicate they might not heal ulcers as quickly as methods like total contact casts, their comfort and ease of use make them popular.

Serious side effects from these boots are rarely reported, making them a well-tolerated option. Following usage instructions and attending follow-up appointments is important for achieving the best results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for diabetic foot ulcers, which typically involves dressings and sometimes offloading shoes, the removable cam walker boot offers a unique approach by providing consistent pressure relief to the affected area. Researchers are excited about this treatment because it combines mobility with effective offloading, potentially improving healing times without compromising patient comfort and daily activity. Additionally, the inclusion of counseling in the treatment plan could enhance patient adherence, leading to better overall outcomes.

What evidence suggests that this trial's treatments could be effective for diabetic foot ulcers?

Research has shown that the removable cam walker boot, under study in this trial, effectively treats diabetic foot ulcers. Studies have found it works as well as traditional casts in shrinking ulcers and promoting faster healing. The boot allows patients to walk while reducing pressure on the ulcer, speeding up healing without limiting movement. It is also easier for patients to use compared to other methods, which may improve adherence to their treatment plan. Overall, the removable cam walker boot offers hope for faster healing and a better quality of life for people with diabetic foot ulcers. ^{1 3 4 5 6}

Who Is on the Research Team?

Muturi G. Muriuki, PhD

Principal Investigator

Edward Hines Jr. VA Hospital, Hines, IL

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2890332/

Effectiveness of Removable Walker Cast Versus ... The Stabil-D cast walker, although removable, was equivalent in efficacy to the TCC in terms of ulcer size reduction and total healing rate.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1350453322001382

The effect of existing and novel walker boot designs on ... The offloading effectiveness of TCCs in diabetes has been demonstrated [9]; however, their adoption by clinicians is low, with less than 2% of podiatrists ...

3. jfootankleres.biomedcentral.com jfootankleres.biomedcentral.com/articles/10.1186/s13047-023-00625-z

Offloading effects of a removable cast walker with and without ... It has been estimated that 19–34% of people with diabetes mellitus will develop a diabetes related foot ulcer (DRFU) in their lifetime [1].

4. withpower.com withpower.com/trial/phase-diabetic-foot-2-2022-ba46e

Orthotic Treatment 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8370012/

Effectiveness of offloading interventions to heal foot ulcers ... Outcomes included ulcer healing, plantar pressure, ambulatory activity, adherence, adverse events, patient-reported measures, and cost-effectiveness. Included ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10562689/

Total contact casts versus removable offloading ... The use of TCCs in patients with DFUs resulted in improved rates of ulcer healing and shorter healing time compared to removable walking casts and footwear.