Total Contact Soft Cast for Diabetic Foot Ulcers

Overseen By Joseph Schuster

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Allergy to calamine, zinc oxide, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wrap called a total contact soft cast to evaluate its effectiveness in healing diabetic foot ulcers. Researchers aim to determine if it is more effective and easier for patients to use than other common treatments like special boots or crutches. The trial includes three groups: one using traditional methods, one with the soft cast and a removable boot (also known as a CAM Walker), and one with just the soft cast. Adults with diabetic foot ulcers who do not have allergies to certain ingredients and can visit the clinic regularly might be suitable candidates for this study. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future treatment options.

Do I need to stop taking my current medications for the trial?

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

What prior data suggests that the total contact soft cast is safe for diabetic foot ulcers?

Research has shown that total contact soft casts are generally well-tolerated by people with diabetic foot ulcers. One study found that 76% of patients experienced successful ulcer healing, with an average healing time of 33 days. This suggests that the casts work effectively without major problems.

For those using a removable cam boot, studies indicate they can be as effective as traditional casts in reducing ulcer size and healing time. However, some people might experience balance issues or joint discomfort because the boots can make one leg longer than the other.

Overall, both treatments appear safe, with no serious side effects reported in the studies. This is encouraging for those considering participation in the clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the total contact soft cast treatments for diabetic foot ulcers because they offer a new way to offload pressure from the ulcers, potentially improving healing outcomes. Unlike conventional treatments that use a variety of devices like cam boots and crutches, the soft cast provides a more uniform and snug fit, which may enhance comfort and compliance. Additionally, the option of a removable cam boot allows for easier inspection and care of the ulcer, potentially leading to better management of the condition. These features could make a significant difference in the healing process, offering a promising alternative to standard care methods.

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

Research shows that total contact casts (TCCs) effectively heal diabetic foot ulcers. Studies indicate that TCCs help ulcers heal faster than methods like walking casts or special shoes. One study found that 90% of diabetic foot ulcers healed with TCCs. In this trial, participants in one arm will receive a total contact soft cast with a removable cam boot, which research shows can help by reducing pressure on the foot, similar to other orthopedic boots. Another arm will provide participants with a total contact soft cast without a removable cam boot. These findings suggest that both treatment methods could effectively heal foot ulcers. ^{2 3 4 6 7}

Who Is on the Research Team?

Joseph Schuster, DPM

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

Adults with diabetic foot ulcers can join this trial. It's not for those allergic to Calamine or Zinc oxide, who can't have their leg wrapped, or can't commit to weekly visits. Prisoners and individuals unable to consent are also excluded.

Inclusion Criteria

I have a diabetic foot ulcer.

Exclusion Criteria

I cannot attend weekly or as-needed appointments.

Unable or unwilling to consent

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a total contact soft cast with or without a removable cam boot for diabetic foot ulcers

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cam Boot
• Total Contact Soft Cast

Trial Overview The trial is testing the effectiveness of a total contact soft cast versus a Cam Boot on diabetic foot ulcers. It looks at how well patients tolerate each treatment, how easy they are to use, and their safety.

How Is the Trial Designed?

Group I: Soft Cast without a Removable Cam Boot Experimental Treatment 1 Intervention

Patients with a foot, ankle, or lower leg ulcer (which we expect to be mostly diabetic foot ulcers) will be provided with a total contact soft cast.

Group II: Soft Cast with a Removable Cam Boot Experimental Treatment 2 Interventions

Patients with a foot, ankle, or lower leg ulcer (which we expect to be mostly diabetic foot ulcers) will be provided with a total contact soft cast with removable cam boot.

Group III: Conventional Active Control 1 Intervention

Patients with a foot, ankle, or lower leg ulcer (which we expect to be mostly diabetic foot ulcers) will use conventional offloading including total contact casting, removable cast boots (cam boots), CROW boots, bracing, AFO's, offloading shoes, insoles, padding, shoe modifications, crutches, wheelchairs, rollabout, and surgical correction.

Total Contact Soft Cast is already approved in United States, European Union for the following indications:

Approved in United States as Total Contact Cast for:

• Diabetic foot ulcers
• Neuropathic fractures (Charcot fractures)

Approved in European Union as Total Contact Cast for:

• Diabetic foot ulcers
• Neuropathic fractures (Charcot fractures)

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Total contact casting (TCC) effectively healed 85% of diabetic foot ulcers in a study of 28 patients over an average follow-up of 2.8 years, demonstrating its efficacy as a treatment.

Despite the high healing rate, the study found a concerning 57% recurrence rate of ulcers, suggesting that additional preventive measures, such as correcting underlying foot deformities, are necessary to reduce future occurrences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrence and prevention of diabetic foot ulcers after total contact casting. Frigg, A., Pagenstert, G., Schäfer, D., et al.[2014]

In a study involving 23 Lebanese diabetic patients, total contact casting (TCC) was used to treat non-healing foot ulcers, with 75% of patients achieving complete ulcer closure after an average of 6 weeks of treatment.

The treatment was effective and safe, as there were no reported complications during the one-year follow-up period, highlighting TCC as a promising option for managing diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of total contact cast in non-healing diabetic foot ulcers in Lebanese patients. Merheb, M., Gharios, E., Younes, A., et al.[2021]

In a study of 50 patients with diabetic foot ulcers, the Total Contact Softcast (TCS) showed a healing ratio of 74%, similar to the 65% healing ratio of the conventional Total Contact Cast (TCC), indicating that TCS is an effective alternative for ulcer treatment.

The mean healing time for ulcers was shorter with TCS at 5.5 weeks compared to 8.4 weeks for TCC, suggesting that TCS may lead to faster recovery, although further randomized studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing a non-removable total contact cast with a non-removable softcast in diabetic foot ulcers: A retrospective study of a prospective database. Vierhout, BP., Visser, R., Hutting, KH., et al.[2022]

In a case study of a 47-year-old woman with a long-standing diabetic foot ulcer, a combination of treatments including sharp debridement, negative pressure wound therapy, and a customized felt offloading method led to successful wound closure in 15 weeks, despite the inability to use total contact casting (TCC).

The use of felt for offloading proved to be an effective alternative to TCC, suggesting that further research is needed to optimize its application and explore its effectiveness in different foot areas and with various offloading devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Best Practice in the Treatment of a Complex Diabetic Foot Ulcer: A Case Report. Blakely, M.[2020]

In a study of 22 patients with diabetic foot ulcers treated with total contact cast (TCC), there was a significant reduction in inflammatory proteases MMP-2 and MMP-9 after 3 weeks, indicating a positive shift towards healing.

The increase in tissue inhibitors TIMP-1 and TIMP-2 after 6 weeks of TCC treatment suggests that the healing process is progressing from the inflammatory phase to the proliferation phase, which is crucial for effective wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Swift Downregulation of Gelatinases (MMP-2, MMP-9) in Neuropathic Diabetic Foot Ulcers Treated With Total Contact Cast. Alvarez, OM., Markowitz, L., Onumah, N., et al.[2019]

In a study of 52 diabetic patients with neuropathic foot ulcers, 78.84% of ulcers healed using Total Contact Cast (TCC) treatment, with an average healing time of 32 days.

TCC was particularly effective for ulcers located on the forefoot and midsole, with a 90% healing rate, while ulcers on pressure-bearing areas like the heel had a higher failure rate, indicating the importance of ulcer location in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total contact cast for neuropathic diabetic foot ulcers. Ali, R., Qureshi, A., Yaqoob, MY., et al.[2014]

Total contact casts (TCC) are highly effective for healing diabetic foot ulcers (DFU), yet they are underutilized in clinical practice, with only about 25% of cases receiving this treatment despite its proven success.

Barriers to TCC adoption include Medicare payment structures, insufficient clinical training, and various patient-related factors, highlighting the need for improved education and policy changes to enhance its use in outpatient wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Not Available]. Shah, S.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11633339/

Biomechanical effectiveness of controlled ankle motion boots This systematic review aimed to summarise the biomechanical benefits and implications of CAM boot wear as an orthotic device for restricting ankle RoM and ...

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

The effect of existing and novel walker boot designs on ... Orthopedic walker boots are often used to treat foot ulcers and other wounds with the goal of offloading plantar pressure. However, poor ulcer healing ...

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

Effectiveness of offloading interventions to heal foot ulcers ... They reported similar ulcer healing rates after 12 weeks (92% vs 83% vs 93% vs 81%, respectively; P > .05) and time-to-healing (47.4 vs 50.5 vs 36.1 vs 41.4 ...

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

Orthotic 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 ...

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

Offloading effects of a removable cast walker with and ... This study aimed to quantify plantar pressure reductions with an RCW with and without modification for DRFUs.

6. 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.

7. iwgdfguidelines.org iwgdfguidelines.org/wp-content/uploads/2017/10/FO.pdf

Footwear and offloading interventions to prevent and heal ... Primary outcomes were ulcer prevention, ulcer healing, and pressure reduction. We reviewed both controlled and non-controlled studies. Controlled studies were ...