Instant Total Contact Cast to Heal Diabetic Foot Ulcers (ITCC)

Study Description

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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.

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

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.

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.	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.
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.	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.
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.	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.

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

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

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Lawrence Lavery, DPM	214-645-0544	LLAVE1@mednet.swmed.edu
Contact: Cecilia Lara	214-645-2377	cecilia.lara@utsouthwestern.edu

Locations

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

Sponsors and Collaborators

University of Texas Southwestern Medical Center

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:	Lawrence Lavery, DPM	UT Southwestern Medical Center at Dallas

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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