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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01221207
First received: October 13, 2010
Last updated: October 15, 2010
Last verified: October 2010
  Purpose

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 Intervention
Diabetic Foot Ulcers
Device: Total Contact Cast
Device: Instant Total Contact Cast (ITCC)
Device: Removable Cast Walker (RCW)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Instant Total Contact Cast to Heal Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 225
Study Start Date: October 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221207

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

No publications provided

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
Study First Received: October 13, 2010
Last Updated: October 15, 2010
Health Authority: United States: National Institute of Diabetes and Digestive and Kidney Diseases (NIHDDK)

Keywords provided by University of Texas Southwestern Medical Center:
diabetic foot ulcers
casting
wound care

Additional relevant MeSH terms:
Foot Ulcer
Diabetic Foot
Foot Diseases
Ulcer
Pathologic Processes
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on August 25, 2014