Instant Total Contact Cast to Heal Diabetic Foot Ulcers

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcers
• Interventions: Device: Total Contact Cast; Device: Removable Cast Walker (RCW); Device: Instant Total Contact Cast (ITCC)

• Registration Number: NCT01221207
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

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 Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-13
• Study First Submitted QC: 2010-10-13
• Study First Posted: 2010-10-14
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2020-08
• Results First Submitted: 2020-08-11
• Results First Submitted QC: 2020-08-11
• Last Update Submitted: 2020-08-11
• Results First Posted: 2020-08-24
• Last Update Posted: 2020-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device - Total Contact Cast (TCC)	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.
Removable Cast Walker (RCW)	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.
Instant Total Contact Cast (ITCC)	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.

Primary Outcome Measures

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

Trial Locations

Locations (4)

University of Arizona; 🇺🇸 Tucson, Arizona, United States

UT Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States

Parkland Health & Hospital Systems; 🇺🇸 Dallas, Texas, United States

Scott & White; 🇺🇸 Temple, Texas, United States