New treatment for pyoderma gangrenosum using EpiFix
A Novel Therapeutic Treatment of Pyoderma Gangrenosum
PHASE4 · Louisiana State University Health Sciences Center in New Orleans · NCT05120726
This study is testing if EpiFix can help heal painful ulcers in people with pyoderma gangrenosum.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Louisiana State University Health Sciences Center in New Orleans (other) |
| Locations | 3 sites (Metairie, Louisiana and 2 other locations) |
| Trial ID | NCT05120726 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of EpiFix, a dehydrated human amnion/chorion membrane, in treating pyoderma gangrenosum, a chronic skin condition characterized by painful ulcers. Patients diagnosed with this condition will undergo a pre-screening process, followed by surgical treatment of their wounds with EpiFix. A second surgery will involve skin grafting approximately one week later. The study will also investigate the genetic mechanisms behind the healing process to enhance understanding and treatment of pyoderma gangrenosum.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with pyoderma gangrenosum.
Not a fit: Patients who are under 18 years old or belong to vulnerable populations, such as pregnant women or prisoners, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing outcomes for patients suffering from pyoderma gangrenosum.
How similar studies have performed: Previous studies have shown success in treating pyoderma gangrenosum with EpiFix, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients diagnosed with pyoderma gangrenosum * patients over 18 years of age Exclusion Criteria: * members of vulnerable populations (pregnant women and prisoners) * patients less than 18 years of age
Where this trial is running
Metairie, Louisiana and 2 other locations
- LSU Healthcare Network Clinic — Metairie, Louisiana, United States (RECRUITING)
- University Medical Center — New Orleans, Louisiana, United States (RECRUITING)
- Ochsner Baptist Medical Center — New Orleans, Louisiana, United States (ENROLLING_BY_INVITATION)
Study contacts
- Principal investigator: Alison Smith, MD, PhD — Louisiana State University Health Sciences Center - New Orleans
- Study coordinator: Alison Smith, MD, PhD
- Email: asmi60@lsuhsc.edu
- Phone: 504-903-9009
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pyoderma Gangrenosum, EpiFix, dehydrated human amnion/chorion membrane