Total Contact Soft Cast in Diabetic Foot Ulcers
Part of paid clinical trials in Minneapolis, Minnesota.
- Sponsor
- University of Minnesota
- Study ID
- NCT04210089
- Status
- Recruiting
Conditions
- Ankle Ulcer
- Diabetes Mellitus
- Diabetic Foot Ulcer
- Foot Ulcer
- Foot Ulcer, Diabetic
- Ulcer
- Ulcer Foot
- Ulcer, Leg
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Total Contact Soft Cast — DEVICEThe total contact soft cast will consist of wound dressing of choice to the ulcer and a plantar foot accommodative offloading felt pad for all foot ulcers, with 4x4 gauze pads added to the arch to create a rocker bottom for metarsophalangeal joint (MPJj) and plantar heel ulcers. The next layers will be: * Unna boot from MPJs to just below the knee, * Sterile Kerlix from MPJs to just below the knee * Sterile 4 inch Kling wrap from the MPJs to just below the knee, * Four inch coban from MPJs to just below the knee, and * Ace wraps from MPJs to just below the knee
- Cam Boot — DEVICERemovable Diabetic cam boot will be used in patients willing and capable of using it. If patient does not want to use Diabetic cam boot then surgical shoe or regular shoe would be options.
Study Details
To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.
Key Dates
- Start date
- Oct 13, 2020
- Status verified
- Dec 2025
- Primary completion
- Oct 1, 2026
- Completion
- Oct 1, 2026
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Soft Cast with a Removable Cam BootPatients 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.
- Experimental: Soft Cast without a Removable Cam BootPatients 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.
- No Intervention: ConventionalPatients 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.
Primary Outcome Measure
Complete Healing Rates [ Time Frame: 16 weeks ]
Central Contacts
- Joseph Schuster612-273-9400
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55454 |
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