Instant Total Contact Cast to Heal Diabetic Foot Ulcers (ITCC)

The University of Texas System (UT)

Status: Completed

Conditions: Diabetic Foot Ulcers

Treatments: Device: Removable Cast Walker (RCW); Device: Instant Total Contact Cast (ITCC); Device: Total Contact Cast

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01221207

UTSW - 7R01DK074483-04

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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225 participants in 3 patient groups

Device - Total Contact Cast (TCC)

Active Comparator group

Description:

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.

Treatment:

Device: Total Contact Cast

Removable Cast Walker (RCW)

Active Comparator group

Description:

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.

Treatment:

Device: Removable Cast Walker (RCW)

Instant Total Contact Cast (ITCC)

Active Comparator group

Description:

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.

Treatment:

Device: Instant Total Contact Cast (ITCC)