Clinical Trials Logo

Clinical Trial 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.

Clinical Trial Description

In part because of its efficacy, the number of clinical indications for dehydrated human amnion/chorion membrane (dHACM) has expanded, and a number of case reports now suggest pyoderma gangrenosum can be successfully treated with dHACM. However, the mechanisms underlying dHACM's beneficial effects is entirely unstudied. The overall goal of the proposed study is to characterize the transcriptome of a pyoderma gangrenosum wound before and after successful treatment with dHACM. We will identify certain genes or genetic pathways that are specifically targeted by treatment of a wound with dehydrated human amnion/chorion membrane (EpiFix). With this data, we hope to better understand the method by which EpiFix can specifically heal a wound. Ultimately, all this data will be used to identify specific findings that aid in the diagnosis and treatment of pyoderma gangrenosum. A previous IRB-approved study by Dr. Frank Lau at LSU and colleagues (unpublished data) investigated the use of EpiFix to treat wounds in 3 patients with pyoderma gangrenosum with success and minimal complications. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05120726
Study type Interventional
Source Louisiana State University Health Sciences Center in New Orleans
Contact Alison Smith, MD, PhD
Phone 504-903-9009
Email [email protected]
Status Recruiting
Phase Phase 4
Start date June 2, 2021
Completion date August 1, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04901325 - Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG) Phase 2
Completed NCT03311464 - A Study Assessing the Efficacy and Safety of Adalimumab in Active Ulcer(s) of Pyoderma Gangrenosum in Participants in Japan Phase 3
Completed NCT00791557 - Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease N/A
Terminated NCT02318914 - A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Subjects With Pyoderma Gangrenosum Phase 3
Terminated NCT02315417 - An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum Phase 3
Completed NCT03137160 - An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum Phase 2
Active, not recruiting NCT04895566 - Phase 0/1 Local Application of the Monoclonal Antibody (Mab) sB24M in Patients With Purulent Pyoderma Early Phase 1
Withdrawn NCT04274166 - Secukinumab for the Inflammatory Phase of Pyoderma Gangrenosum Phase 2
Completed NCT01882504 - Proof of Concept Study of Gevokizumab in the Treatment of Pyoderma Gangrenosum Phase 2
Withdrawn NCT00730717 - Safety and Efficacy Study of Humira in Treatment of Pyoderma Gangrenosum Phase 2
Recruiting NCT03971643 - Exploratory Study of IFX-1 in Subjects With Pyoderma Gangrenosum Phase 2
Terminated NCT03072953 - Efficacy and Safety of APD334 in Patients With Pyoderma Gangrenosum Phase 2
Withdrawn NCT00690846 - Study to Determine the Safety and Efficacy of Adalimumab in the Treatment of Pyoderma Gangrenosum Phase 2
Completed NCT01965613 - A Phase II Open Label Study of Xilonix in Subjects With Pyoderma Gangrenosum Phase 2
Recruiting NCT01952275 - Observational Study of the Genetic Architecture of Neutrophil-Mediated Inflammatory Skin Diseases N/A
Completed NCT01302795 - Canakinumab for Pyoderma Gangrenosum Phase 2
Recruiting NCT04750213 - A Study to Assess Adverse Events and Change in Disease State in Adult Participants Being Treated With Humira in Participants Diagnosed With Pyoderma Gangrenosum (PG)
Not yet recruiting NCT03636737 - Study on the Clinical Features, Comorbidities and Pathologies Associated With Pyoderma Gangrenosum
Terminated NCT02326740 - An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum Phase 3
Not yet recruiting NCT04792957 - JAK-STAT Signaling Pathway in Pyoderma Gangrenosum