Status:
COMPLETED
Instant Total Contact Cast to Heal Diabetic Foot Ulcers
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetic Foot Ulcers
Eligibility:
All Genders
18+ years
Phase:
NA
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 tria...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT01221207
Start Date
October 1 2010
End Date
October 1 2012
Last Update
August 24 2020
Active Locations (4)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
Parkland Health & Hospital Systems
Dallas, Texas, United States, 75235
3
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
4
Scott & White
Temple, Texas, United States, 76502