Instant Total Contact Cast to Heal Diabetic Foot Ulcers

NCT01221207 | Completed Results DMC FDA Device

• 1 other identifier: UTSW - 7R01DK074483-04
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetic Foot Ulcers

Keywords

diabetic foot ulcers; casting; wound care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Device - Total Contact Cast (TCC)

ACTIVE COMPARATOR

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

Removable Cast Walker (RCW)

ACTIVE COMPARATOR

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)

Instant Total Contact Cast (ITCC)

ACTIVE COMPARATOR

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)

Interventions

Total Contact Cast DEVICE

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 (TCC)

Instant Total Contact Cast (ITCC) DEVICE

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)

Removable Cast Walker (RCW) DEVICE

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (4)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Parkland Health & Hospital Systems

Dallas, Texas, 75235, United States

Location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Scott & White

Temple, Texas, 76502, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Lawrence Lavery, DPM, MPH
• Organization: UT Southwestern Medical Center at Dallas

Larry.Lavery@UTSouthwestern.edu

214-645-0544

Study Officials

• Lawrence Lavery, DPM

  UT Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: October 14, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: August 24, 2020
• Results First Posted: August 24, 2020

Record last verified: 2020-08

Locations

US (4)