Clinical trial NCT01221207: Instant Total Contact Cast to Heal Diabetic Foot Ulcers
Official title: Instant Total Contact Cast to Heal Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcers
Keywords: diabetic foot ulcers
casting
wound care
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-10-14
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Achieve Full Wound Healing.
timeFrame: 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Dallas
country: United States
facility: Parkland Health & Hospital Systems
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Temple
country: United States
facility: Scott & White
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center at Dallas
name: Lawrence Lavery, DPM
role: PRINCIPAL_INVESTIGATOR
References: