Instant Total Contact Cast to Heal Diabetic Foot Ulcers

Diabetic Foot Ulcers Clinical Trial

— ITCC  

Official title:

Instant Total Contact Cast to Heal Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221207
• Other study ID #: UTSW - 7R01DK074483-04
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: October 2012

Study information

• Verified date: August 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Parkland Health & Hospital Systems	Dallas	Texas
United States	UT Southwestern Medical Center at Dallas	Dallas	Texas
United States	Scott & White	Temple	Texas
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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