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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Healing Rates
Secondary outcome measures
Patient Compliance with Use of the Total Contact Soft Cast
Patient Complications

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.

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,381 Previous Clinical Trials
1,588,675 Total Patients Enrolled
Joseph Schuster, DPMPrincipal InvestigatorUniversity of Minnesota

Media Library

Total Contact Soft Cast (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04210089 — N/A
Foot Ulcer Research Study Groups: Conventional, Soft Cast with a Removable Cam Boot, Soft Cast without a Removable Cam Boot
Foot Ulcer Clinical Trial 2023: Total Contact Soft Cast Highlights & Side Effects. Trial Name: NCT04210089 — N/A
Total Contact Soft Cast (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04210089 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current magnitude of participants in this research endeavor?

"Affirmative. Clinicaltrials.gov records that this study is actively recruiting, having been first posted on October 13th 2020 and most recently revised on March 1st 2022. The trial requires 100 participants from a single location to proceed successfully."

Answered by AI

Are there any patient vacancies in this clinical experiment?

"Absolutely. On clinicaltrials.gov, this medical experiment is listed as actively recruiting; the trial was initially posted on October 13th 2020 and has recently been updated on March 1st 2022. One hundred people are being recruited from one site for participation in the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Total Contact Soft Cast in Diabetic Foot Ulcers
2020. "Total Contact Soft Cast in Diabetic Foot Ulcers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04210089.
~11 spots leftby Oct 2024
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