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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: Completed NA study of Diabetic Foot Ulcers, sponsored by University of Texas Southwestern Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
We will evaluate wounds at each clinical visit. An ulcer will be considered "healed" when it is fully epithelialized with no drainage.
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 |
What the finished NCT01221207 record still lists
NCT01221207 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 216-participant average among 12 other Diabetic Foot Ulcers trials with a reported enrollment target.
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Diabetic Foot Ulcers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01221207's enrollment target sits among peer trials
225 5th of 12 higher than 8 of 12 other Diabetic Foot Ulcers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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