Total Contact Soft Cast in Diabetic Foot Ulcers

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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 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.

Official Title
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Total Contact Soft Cast in Diabetic Foot Ulcers

Conditions
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Ulcer, Diabetic Foot Ulcer, Diabetes Mellitus, Foot Ulcer, Foot Ulcer, Diabetic, Ulcer Foot, Ulcer, Leg, Ankle Ulcer

Intervention / Treatment
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* Device: Total Contact Soft Cast
* Device: Cam Boot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Any adult with a diabetic foot ulcer Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soft Cast with a Removable Cam Boot<br>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. | Device: Total Contact Soft Cast<br>* 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: 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<br>Device: Cam Boot<br>* 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.<br>|
| Experimental: Soft Cast without a Removable Cam Boot<br>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. | Device: Total Contact Soft Cast<br>* 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: 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<br>|
| No Intervention: Conventional<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | The percentage of patients who need to stop using the soft case due to complications will be calculated. | 16 weeks |