RECRUITING

A Novel Therapeutic Treatment of Pyoderma Gangrenosum

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Novel Therapeutic Treatment of Pyoderma Gangrenosum

Quick Facts

Study Start:2021-06-02
Study Completion:2026-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05120726

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * patients diagnosed with pyoderma gangrenosum
  2. * patients over 18 years of age
  1. * members of vulnerable populations (pregnant women and prisoners)
  2. * patients less than 18 years of age

Contacts and Locations

Study Contact

Alison Smith, MD, PhD
CONTACT
504-903-9009
asmi60@lsuhsc.edu

Principal Investigator

Alison Smith, MD, PhD
PRINCIPAL_INVESTIGATOR
Louisiana State University Health Sciences Center - New Orleans

Study Locations (Sites)

LSU Healthcare Network Clinic
Metairie, Louisiana, 70006
United States
University Medical Center
New Orleans, Louisiana, 70112
United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, 70115
United States

Collaborators and Investigators

Sponsor: Louisiana State University Health Sciences Center in New Orleans

  • Alison Smith, MD, PhD, PRINCIPAL_INVESTIGATOR, Louisiana State University Health Sciences Center - New Orleans

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-02
Study Completion Date2026-05-01

Study Record Updates

Study Start Date2021-06-02
Study Completion Date2026-05-01

Terms related to this study

Keywords Provided by Researchers

  • Pyoderma Gangrenosum
  • EpiFix
  • dehydrated human amnion/chorion membrane

Additional Relevant MeSH Terms

  • Pyoderma Gangrenosum