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NCT02131961 · ClinicalTrials.gov registry record · Phase 1
EZCast-DFU Study With Portal for Application of Topical Medications
A Phase 1 study, sponsored by University of Miami.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT02131961: Completed Phase 1 study, sponsored by University of Miami.
NCT02131961 is a Phase 1 study that has completed, run by University of Miami. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02131961, a Phase 1 study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
This study is designed to evaluate the ability to modify a contact cast system so that topical medications can be applied daily to an underlying wound in patients with diabetic plantar ulcers. The modification of the cast will be done by making an opening where the wound is located in the contact cast system. A contact cast system is a device that will reduce the pressure in the area where the wound is located.
Primary Outcome
Proportion of contact cast systems in whom the investigator assesses as intact (not damaged, or broken by the creation of the window). Intact: Contact cast systems where the window creation did not create unintended fissures or these fissures were less than 1cm length and they originate from the window opening. Damaged: Contact cast systems where window creation creates one or more fissure between 1-3cm of length and these fissures originate from the window opening. Broken: Contact cast syste
Interventions
- DRUG Collagenase ointment
- DEVICE Modified Contact Cast System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-10 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
What the finished NCT02131961 record still lists
NCT02131961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Collagenase ointment is the first listed.
NCT02131961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02131961 about?
NCT02131961 is a clinical study titled "EZCast-DFU Study With Portal for Application of Topical Medications". This study is designed to evaluate the ability to modify a contact cast system so that topical medications can be applied daily to an underlying wound in patients with diabetic plantar ulcers. The modification of the cast will be done by making an opening where the wound is located in the contact ca...
What is the current status of trial NCT02131961?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2014-10. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02131961?
The interventions under investigation include: Collagenase ointment (DRUG), Modified Contact Cast System (DEVICE).
Who is sponsoring clinical trial NCT02131961?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02131961's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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