Instant Total Contact Cast (ITCC) To Heal Diabetic Foot Ulcers: An Investigator Blinded Randomized, Controlled Clinical Trial with Three Parallel Treatment Groups

Study ID
STU 082010-225

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other
  • UT Southwestern-Clinical Translational Research Center (CTRC)
  • Parkland Health & Hospital System

Contact
Xiaohong Xu
214/645-8908
xiaohong.xu@utsouthwestern.edu

Principal Investigator
Lawrence Lavery

Summary

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.

noTe: although the grant and protocol have indicated inclusion of sites at Lutheran General Hospital and the north Chicago Veterans affairs Medical Center, these sites were never opened, and the protocol is not being conducted there.

Participant Eligibility

Men or women 18 years old or older
One or more foot ulcers without clinical evidence of osteomyelitis[?] Osteomyelitis may be treated and resolved.
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