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Dehydrated human amnion/chorion membrane for Pyoderma Gangrenosum

Phase 4
Waitlist Available
Led By Alison Smith, MD, PhD
Research Sponsored by Louisiana State University Health Sciences Center in New Orleans
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ~6 months (post-op weeks 1, 2, 3, 4, 5, 6, 10, 14, 18, 22; +/- 2 weeks each time in case conflicts arise)
Awards & highlights

Study Summary

This study is evaluating whether a surgery to treat wounds with EpiFix can improve the healing of wounds in people with pyoderma gangrenosum.

Eligible Conditions
  • Pyoderma Gangrenosum

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~~6 months (post-op weeks 1, 2, 3, 4, 5, 6, 10, 14, 18, 22; +/- 2 weeks each time in case conflicts arise)
This trial's timeline: 3 weeks for screening, Varies for treatment, and ~6 months (post-op weeks 1, 2, 3, 4, 5, 6, 10, 14, 18, 22; +/- 2 weeks each time in case conflicts arise) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gene Measurements
Wound Size
Secondary outcome measures
Infection
Pain Level

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Patient's pyoderma gangrenosum wounds are treated surgically with EpiFix (dehydrated human amnion/chorion membrane). In another surgery about one week later, we will be covering the treated wounds with split-thickness skin grafts. During each surgery, we will be collecting wound samples for genetic analysis. Routine post-surgery clinic visits will be used to monitor wound healing over a 6-month period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dehydrated human amnion/chorion membrane
2017
N/A
~70

Find a Location

Who is running the clinical trial?

Louisiana State University Health Sciences Center in New OrleansLead Sponsor
114 Previous Clinical Trials
44,181 Total Patients Enrolled
Alison Smith, MD, PhDPrincipal InvestigatorLouisiana State University Health Sciences Center - New Orleans

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
International Wound JournalJournal
Biological Properties of Dehydrated Human Amnion/chorion Composite Graft: Implications for Chronic Wound Healing
Koob, Thomas J, Robert Rennert, Nicole Zabek, Michelle Massee, Jeremy J Lim, Johnna S Temenoff, William W Li, and Geoffrey Gurtner. 2013. “Biological Properties of Dehydrated Human Amnion/chorion Composite Graft: Implications for Chronic Wound Healing”. International Wound Journal. Wiley. doi:10.1111/iwj.12140.
clinicaltrials.govStudy
A Novel Therapeutic Treatment of Pyoderma Gangrenosum
Alison A. Smith 2021. "A Novel Therapeutic Treatment of Pyoderma Gangrenosum". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05120726.
~5 spots leftby Apr 2025
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