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Completed

NCT Number: NCT01221207

Instant Total Contact Cast to Heal Diabetic Foot Ulcers

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Number of Participants Who Achieve Full Wound Healing.

    Time frame: 20 weeks

    We will evaluate wounds at each clinical visit. An ulcer will be considered "healed" when it is fully epithelialized with no drainage.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: ITCC

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 14, 2010
Registry last updated
Aug 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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