At a glance
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Instant Total Contact Cast to Heal Diabetic Foot Ulcers
In Brief
A clinical study evaluating Total Contact Cast, Instant Total Contact Cast (ITCC), and 1 other intervention for Diabetic Foot Ulcers. Completed, enrolled 225 participants across 4 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
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.
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.
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.