View Clinical Trial (Medical Research Study)
Instant Total Contact Cast to Heal Diabetic Foot Ulcers
| City: |
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Dallas |
| State: |
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Texas |
| Zip Code: |
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75390 |
| Conditions: |
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Diabetic Foot Ulcers |
| Purpose: |
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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.
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| Study Summary: |
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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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| Criteria: |
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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
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| NCT ID: |
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NCT01221207 |
| Primary Contact: |
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Principal Investigator
Lawrence Lavery, DPM
UT Southwestern Medical Center at Dallas
Lawrence Lavery, DPM
Phone: 214-645-0544
Email: LLAVE1@mednet.swmed.edu
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| Backup Contact: |
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Email: cecilia.lara@utsouthwestern.edu
Cecilia Lara
Phone: 214-645-2377
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| Location Contact: |
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Dallas, Texas 75390
United States
Lawrence Lavery, DPM
Phone: 214-645-0544
Email: LLAVE1@mednet.swmed.edu
Site Status: Not yet recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
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