Diabetic Foot Ulcers Clinical Trial
Official title:
Instant Total Contact Cast to Heal Diabetic Foot Ulcers
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.
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. ;
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