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Total Contact Soft Cast for Diabetic Foot Ulcers

N/A

Recruiting

Led By Joseph Schuster, DPM

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any adult with a diabetic foot ulcer

Be older than 18 years old

Must not have

Inability to be seen weekly or as needed

Persons lacking capacity to consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new type of cast for people with diabetes who have ulcers on their feet. They want to see if it is effective, easy to use, and safe.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include skin irritation due to materials in the casts or boots, discomfort from wearing them, and possible increased risk of infection if not monitored properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a diabetic foot ulcer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot attend weekly or as-needed appointments.

Select...

I am unable to make medical decisions for myself.

Select...

I cannot have my leg wrapped.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Healing Rates

Secondary study objectives

Patient Compliance with Use of the Total Contact Soft Cast

Patient Complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Soft Cast without a Removable Cam BootExperimental Treatment1 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 BootExperimental Treatment2 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: ConventionalActive Control1 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.

0 / 4Eligibility criteria met