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NCT01221207 · ClinicalTrials.gov registry record · NA
Instant Total Contact Cast to Heal Diabetic Foot Ulcers
A NA study of Diabetic Foot Ulcers, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 225
- Enrollment target
- 4
- Study locations
NCT01221207 is a NA study of Diabetic Foot Ulcers that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 225 participants, roughly in line with the 216-participant average among 12 other Diabetic Foot Ulcers trials with a reported enrollment target. The trial reports 4 study locations across 2 states.
The verdict
NCT01221207, a NA study of Diabetic Foot Ulcers, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 225 participants
- Enrollment target
- 4
- Study locations
Study 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.
Conditions Studied
Interventions
- DEVICE Total Contact Cast
- DEVICE Instant Total Contact Cast (ITCC)
- DEVICE Removable Cast Walker (RCW)
Study Locations (4)
Texas
- Parkland Health & Hospital Systems - Dallas
- UT Southwestern Medical Center at Dallas - Dallas
- Scott & White - Temple
Arizona
- University of Arizona - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01221207
The ClinicalTrials.gov registry entry for NCT01221207 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 216-participant average among 12 other Diabetic Foot Ulcers trials with a reported enrollment target. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetic Foot Ulcers appearing as the primary indexed condition, and to 3 interventions - of which Total Contact Cast is the first listed.
NCT01221207 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Texas, Arizona.
Frequently Asked Questions
What is clinical trial NCT01221207 about?
NCT01221207 is a clinical study titled "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 ...
What is the current status of trial NCT01221207?
This trial is currently completed. It is a NA study. The enrollment target is 225 participants. The study started on 2010-10. Estimated completion is 2012-10.
What conditions does trial NCT01221207 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcers.
What interventions are being tested in trial NCT01221207?
The interventions under investigation include: Total Contact Cast (DEVICE), Instant Total Contact Cast (ITCC) (DEVICE), Removable Cast Walker (RCW) (DEVICE).
Who is sponsoring clinical trial NCT01221207?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01221207 being conducted?
This trial has 4 study locations across Arizona, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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