A Novel Therapeutic Treatment of Pyoderma Gangrenosum

Stopped early · Phase 4

Conditions studied: Pyoderma Gangrenosum

In brief

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.

Key facts

Study ID

NCT05120726

Run by

Louisiana State University Health Sciences Center in New Orleans

People needed

5

Starts

2021-06-02

Expected to finish

2024-11-18

Last updated by the study team

2025-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patients diagnosed with pyoderma gangrenosum
• patients over 18 years of age

You may not qualify if…

• members of vulnerable populations (pregnant women and prisoners)
• patients less than 18 years of age

Where it is running

• LSU Healthcare Network Clinic — Metairie, Louisiana, United States
• University Medical Center — New Orleans, Louisiana, United States
• Ochsner Baptist Medical Center — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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