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To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.
This study will evaluate whether the use of a total contact soft cast with or without a removable cam boot is as effective in healing diabetic foot ulcers as more commonly used offloading methods.
The 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:
Removable 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soft Cast with a Removable Cam Boot | Experimental | 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. |
|
| Soft Cast without a Removable Cam Boot | Experimental | 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. |
|
| Conventional | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Contact Soft Cast | Device | The 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Healing Rates | Complete healing is defined as complete epithelization of the ulcer. Outcome will be reported in days. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Compliance with Use of the Total Contact Soft Cast | The percentage of patients who use the total contact soft cast until complete healing or 16 weeks of treatment will be calculated. | 16 weeks |
| Patient Complications |
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Inclusion Criteria:
- Any adult with a diabetic foot ulcer
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph Schuster | Contact | 612-273-9400 | schus122@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joseph Schuster, DPM | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55454 | United States |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003920 | Diabetes Mellitus |
| D016523 | Foot Ulcer |
| D014456 | Ulcer |
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012883 | Skin Ulcer |
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| Cam Boot | Device | Removable 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. |
|
The percentage of patients who need to stop using the soft case due to complications will be calculated.
| 16 weeks |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005534 | Foot Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |