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

Trial Summary

What is the purpose of this trial?

To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.

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

Research shows that Total Contact Casting (TCC) is highly effective in healing diabetic foot ulcers, with studies indicating a 75% success rate in complete ulcer closure without recurrence over a year. However, the use of TCC is limited due to factors like Medicare's payment structure and lack of clinical training, despite its proven success. ^{1 2 3 4 5}

How is the Total Contact Soft Cast treatment different from other treatments for diabetic foot ulcers?

The Total Contact Soft Cast (TCS) is unique because it offers a non-removable off-loading solution that is less disruptive to lifestyle and transportation compared to the traditional Total Contact Cast (TCC), while still effectively promoting healing in diabetic foot ulcers. ^{2 3 5 6 7}

Research Team

Joseph Schuster, DPM

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Pakistan pubmed.ncbi.nlm.nih.gov

Total contact cast for neuropathic diabetic foot ulcers. [2014]

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

[Not Available]. [2015]

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

Recurrence and prevention of diabetic foot ulcers after total contact casting. [2014]

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

Effect of total contact cast in non-healing diabetic foot ulcers in Lebanese patients. [2021]

5. Ireland 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. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Swift Downregulation of Gelatinases (MMP-2, MMP-9) in Neuropathic Diabetic Foot Ulcers Treated With Total Contact Cast. [2019]