Total Contact Soft Cast in Diabetic Foot Ulcers
Key facts
- Who runs it
- University of Minnesota
- Where
- Minneapolis, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 13 Oct 2020
- Expected to end
- 1 Oct 2027
- Type of study
- Interventional, 3 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Total Contact Soft Cast
- Cam Boot
- Record updated
- 2 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Any adult with a diabetic foot ulcer
Who cannot take part
- Allergy to Calamine or Zinc oxide
- Inability to have leg wrapped
- Inability to be seen weekly or as needed
- Unable or unwilling to consent
- Prisoners
- Persons lacking capacity to consent
Where in United States
- University of MinnesotaMinneapolis, United StatesContact: Joseph Schuster, DPMTaking people
About the trial
What the trial wants to find out
To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.
The 3 groups in the trial
- Soft Cast with a Removable Cam BootTreatment being tested
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.
Treatment: Total Contact Soft Cast and Cam Boot
- Soft Cast without a Removable Cam BootTreatment being tested
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.
Treatment: Total Contact Soft Cast
- ConventionalNo study treatment, for comparison
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 2 October 2026