Instant Total Contact Cast to Heal Diabetic Foot Ulcers

Study Overview
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Brief Summary
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Aim 1. To compare the effectiveness of total contact casts (TCC), removable cast walkers (RCW) and instant total contact casts (ITCC) to heal diabetic foot ulcers in a 20 week randomized clinical trial of 225 patients in community care in three university medical center diabetes clinics. Aim 2. To compare the frequency of complications such as soft tissue and bone infections, iatrogenic wounds, falls and fall related injuries, and amputations among patients treated with TCC, ITCC and RCW to heal diabetic foot ulcers. Aim 3. To compare patient compliance and level of activity among TCC, ITCC, RCW treatment groups. Using computerized activity monitors which time-stamp each step, we will evaluate both degree and magnitude of activity between groups. Aim 4. To evaluate the cost of diabetic foot ulcer-related treatment and complications during the course of therapy.

Detailed Description
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This is an investigator blinded randomized, controlled clinical trial with three parallel treatment groups of 75 adult outpatients with diabetes mellitus and a foot ulcer. The study will be conducted at five university affiliated medical centers in Arizona and Texas. The study participants and nurse coordinator will not be blinded to the treatment after randomization. Investigators will be blinded to treatment group assignment.

Official Title
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Instant Total Contact Cast to Heal Diabetic Foot Ulcers

Conditions
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Diabetic Foot Ulcers

Intervention / Treatment
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* Device: Total Contact Cast
* Device: Instant Total Contact Cast (ITCC)
* Device: Removable Cast Walker (RCW)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women 18 years old or older One or more foot ulcers without clinical evidence of osteomyelitis Diagnosis of Diabetes Mellitus University of Texas Grade 1A-B, 2A-B or 3A-B ABI >0.5 Spanish-speaking subjects will be eligible to participate Exclusion Criteria: Active Charcot Arthropathy ABI <0.5 Gangrene, active infection Unable to keep research appointments Wide spread malignancy or systemically immunocompromising disease Alcohol or substance abuse within 6 months Unreliable, unwilling or unable to comprehend informed 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 |
| --- | --- |
| Active Comparator: Device - Total Contact Cast (TCC)<br>A total contact cast (TCC) is a special cast technique that is used to take the pressure and shear stress off the ulcer to assist in the healing. | Device: Total Contact Cast<br>* A total contact cast (TCC) is a special cast technique that is used to take the pressure and shear stress off the ulcer to assist in the healing.<br>|
| Active Comparator: Removable Cast Walker (RCW)<br>The removable cast walker (RCW) is a commercial product that is similar to a cast. It is secured with Velcro straps around the foot and leg and it is also effective at removing the pressure and shear stress on the foot. | Device: Removable Cast Walker (RCW)<br>* The removable cast walker (RCW) is a commercial product that is similar to a cast. It is secured with Velcro straps around the foot and leg and it is also effective at removing the pressure and shear stress on the foot.<br>|
| Active Comparator: Instant Total Contact Cast (ITCC)<br>The instant total contact cast (ITCC) is a technique that uses the removable cast walker, but secures it so it cannot be removed between clinic visits and evaluation by the subject or the physician. | Device: Instant Total Contact Cast (ITCC)<br>* The instant total contact cast (ITCC) is a technique that uses the removable cast walker, but secures it so it cannot be removed between clinic visits and evaluation by the subject or the physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieve Full Wound Healing. | We will evaluate wounds at each clinical visit. An ulcer will be considered healed when it is fully epithelialized with no drainage. | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic foot ulcers, casting, wound care