Instant Total Contact Cast to Heal Diabetic Foot Ulcers

Completed · Not applicable

Conditions studied: Diabetic Foot Ulcers

In brief

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.

Key facts

Study ID

NCT01221207

Run by

University of Texas Southwestern Medical Center

People needed

225

Starts

2010-10-01

Expected to finish

2012-10-01

Last updated by the study team

2020-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arizona — Tucson, Arizona, United States
• Parkland Health & Hospital Systems — Dallas, Texas, United States
• UT Southwestern Medical Center at Dallas — Dallas, Texas, United States
• Scott & White — Temple, Texas, United States

Full record on ClinicalTrials.gov

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