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NCT05120726 · ClinicalTrials.gov registry record · Phase 4
A Novel Therapeutic Treatment of Pyoderma Gangrenosum
A Phase 4 study, sponsored by Louisiana State University Health Sciences Center in New Orleans.
- Terminated
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT05120726: Clinical Trial Phase 4 study, sponsored by Louisiana State University Health Sciences Center in New Orleans.
NCT05120726 is a Phase 4 study that was terminated before completion, run by Louisiana State University Health Sciences Center in New Orleans. The registered enrollment target is 5 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05120726, a Phase 4 study, was terminated before completion, sponsored by Louisiana State University Health Sciences Center in New Orleans.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study Summary
Pyoderma gangrenosum is a chronic debilitating ulcerative neutrophilic condition usually affecting the skin. The pathogenesis of pyoderma gangrenosum is poorly understood. Pyoderma gangrenosum has been estimated to have an incidence rate of 3-10 per million populations per year. Mortality estimates range up to 30%. The non-healing wounds present a significant social and economic burden on affected patients. We hypothesize that EpiFix (dehydrated human amnion/chorion membrane) will be beneficial in treating patients with pyoderma gangrenosum. Potentially eligible patients will be pre-screened in clinic. The pre-screening process will include a medical history, including review of co-morbid medical problems and home medications, and a physical exam of the wounds. The first stage of the study will involve a surgery in which the pyoderma gangrenosum wounds are going to be treated with the EpiFix. About a week later, the patient will then undergo another surgery where skin grafts will be placed on the wounds that were treated in the first surgery. In each surgery, samples of the wound will be taken, and genetic information from these samples will be studied to identify the genes that are active before and after treating the wound with EpiFix. Routine post-surgery clinic visits will then be used to monitor the healing of the wounds and make sure that no extra medical treatment is needed. Study staff will evaluate wounds twice a week for the first two weeks, then once a week until 6 weeks. Following this, you will then be followed every 4 weeks up to 22 weeks. These visits to the clinic will include taking wound measurements, taking digital photos, asking about level of pain and evaluating development of infection. Patient consent will be obtained to take any photos.
Primary Outcome
Identifying genes or genetic pathways that are specifically targeted by treatment of a wound with dehydrated human amnion/chorion membrane (dHACM)
Interventions
- BIOLOGICAL Dehydrated human amnion/chorion membrane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-06-02 |
| Est. Completion | 2024-11-18 |
| Phase | Phase 4 |
Why NCT05120726 stopped before completion
NCT05120726 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Dehydrated human amnion/chorion membrane is the first listed.
NCT05120726 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05120726 about?
NCT05120726 is a clinical study titled "A Novel Therapeutic Treatment of Pyoderma Gangrenosum". Pyoderma gangrenosum is a chronic debilitating ulcerative neutrophilic condition usually affecting the skin. The pathogenesis of pyoderma gangrenosum is poorly understood. Pyoderma gangrenosum has been estimated to have an incidence rate of 3-10 per million populations per year. Mortality estimates ...
What is the current status of trial NCT05120726?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2021-06-02. Estimated completion is 2024-11-18.
What interventions are being tested in trial NCT05120726?
The interventions under investigation include: Dehydrated human amnion/chorion membrane (BIOLOGICAL).
Who is sponsoring clinical trial NCT05120726?
This trial is sponsored by Louisiana State University Health Sciences Center in New Orleans, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05120726's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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