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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05120726
The ClinicalTrials.gov registry entry for NCT05120726 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Louisiana State University Health Sciences Center in New Orleans, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dehydrated human amnion/chorion membrane is the first listed.
NCT05120726 reports 0 study locations.
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.
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