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COMPLETED NA

Instant Total Contact Cast to Heal Diabetic Foot Ulcers

NCT01221207 · View on ClinicalTrials.gov ↗

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

FieldValue
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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 742 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01221207 reports 4 study locations spanning 2 distinct geographic areas — top geographies include Texas, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01221207?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 742 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial