Instant Total Contact Cast to Heal Diabetic Foot Ulcers (ITCC)
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ClinicalTrials.gov Identifier: NCT01221207 |
Recruitment Status
: Unknown
Verified October 2010 by University of Texas Southwestern Medical Center.
Recruitment status was: Recruiting
First Posted
: October 14, 2010
Last Update Posted
: October 18, 2010
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Foot Ulcers | Device: Total Contact Cast Device: Instant Total Contact Cast (ITCC) Device: Removable Cast Walker (RCW) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 225 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Instant Total Contact Cast to Heal Diabetic Foot Ulcers |
Study Start Date : | October 2010 |
Estimated Primary Completion Date : | October 2012 |
Estimated Study Completion Date : | October 2012 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 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.
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Device: 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.
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Active Comparator: 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.
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Device: 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.
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Active Comparator: 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.
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Device: 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.
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- Wound Evaluation and Healing: The lower extremity evaluation will include length, width, depth, and area of the ulcer before and after debridement. [ Time Frame: every 10 days, then every 4 months ]We will evaluate wounds at each clinical visit to ensure the absence of infection. At each study visit a research CRC will take photographs of the wound which will be planimetrically measured and assessed by a clinician unaware of specific study allocation. An ulcer will be considered "healed" when it is fully epithelialized with no drainage.
- Evaluation of Complications: At each visit the study nurse will interview patients and determine if they have experienced any adverse events. [ Time Frame: every 10 days, then every 4 months ]This includes exacerbation of existing condition or event. Infection of soft tissue or bone, amputation, need for incision and drainage, iatrogenic ulcer formation, deterioration of the ulcer being treated, hospital admission, surgery of the foot or amputation of the foot or leg will be considered as an adverse event.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01221207
Contact: Lawrence Lavery, DPM | 214-645-0544 | LLAVE1@mednet.swmed.edu | |
Contact: Cecilia Lara | 214-645-2377 | cecilia.lara@utsouthwestern.edu |
United States, Arizona | |
University of Arizona | Recruiting |
Tucson, Arizona, United States | |
Contact: David Armstrong, D 520-626-1349 | |
United States, Texas | |
Parkland Health & Hospital Systems | Not yet recruiting |
Dallas, Texas, United States, 75235 | |
Contact: Lawrence Lavery, DPM 214-645-0544 LLAVE1@mednet.swmed.edu | |
Contact: Cecilia Lara 214-645-2377 cecilia.lara@utsouthwestern.edu | |
UT Southwestern Medical Center at Dallas | Not yet recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Lawrence Lavery, DPM 214-645-0544 LLAVE1@mednet.swmed.edu | |
Contact: Cecilia Lara 214-645-2377 cecilia.lara@utsouthwestern.edu | |
Scott & White | Recruiting |
Temple, Texas, United States | |
Contact: Douglas Murdoch, DPM 214-771-7604 DMurdoch@swmail.sw.org |
Principal Investigator: | Lawrence Lavery, DPM | UT Southwestern Medical Center at Dallas |
Responsible Party: | Lawrence Lavery, DPM, The University of Texas Southwestern Medical Center at Dallas |
ClinicalTrials.gov Identifier: | NCT01221207 History of Changes |
Other Study ID Numbers: |
UTSW - 7R01DK074483-04 |
First Posted: | October 14, 2010 Key Record Dates |
Last Update Posted: | October 18, 2010 |
Last Verified: | October 2010 |
Keywords provided by University of Texas Southwestern Medical Center:
diabetic foot ulcers casting wound care |
Additional relevant MeSH terms:
Diabetic Foot Foot Ulcer Foot Diseases Ulcer Pathologic Processes Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Leg Ulcer Skin Ulcer |
Skin Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies Calpastatin Cysteine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |