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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcers
• Intervention / Treatment: Device: Total Contact Cast; Device: Removable Cast Walker (RCW); Device: Instant Total Contact Cast (ITCC)

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 Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center at Dallas
    • Dallas, Texas, United States, 75235
      • Parkland Health & Hospital Systems
    • Temple, Texas, United States, 76502
      • Scott & White

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Achieve Full Wound Healing.	We will evaluate wounds at each clinical visit. An ulcer will be considered "healed" when it is fully epithelialized with no drainage.	20 weeks

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: October 13, 2010
• First Submitted That Met QC Criteria: October 13, 2010
• First Posted (Estimate): October 14, 2010

Study Record Updates

• Last Update Posted (Actual): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: wound care; diabetic foot ulcers; casting
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Cysteine Proteinase Inhibitors; Calpastatin
• Other Study ID Numbers: UTSW - 7R01DK074483-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes