Instant Total Contact Cast to Heal Diabetic Foot Ulcers
NCT ID: NCT01221207
Last Updated: 2020-08-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
225 participants
INTERVENTIONAL
2010-10-31
2012-10-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Device - Total Contact Cast (TCC)
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.
Total Contact Cast
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.
Removable Cast Walker (RCW)
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.
Removable Cast Walker (RCW)
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.
Instant Total Contact Cast (ITCC)
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.
Instant Total Contact Cast (ITCC)
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.
Interventions
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Total Contact Cast
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.
Instant Total Contact Cast (ITCC)
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.
Removable Cast Walker (RCW)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Larry Lavery
Professor
Principal Investigators
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Lawrence Lavery, DPM
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center at Dallas
Locations
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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
Countries
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Other Identifiers
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UTSW - 7R01DK074483-04
Identifier Type: -
Identifier Source: org_study_id
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