A Novel Therapeutic Treatment of Pyoderma Gangrenosum

NCT05120726 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: IRB: #1579
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Pyoderma Gangrenosum

Keywords

Pyoderma Gangrenosum; EpiFix; dehydrated human amnion/chorion membrane

Outcome Measures

Primary Outcomes (2)

• Gene Measurements

  Identifying genes or genetic pathways that are specifically targeted by treatment of a wound with dehydrated human amnion/chorion membrane (dHACM)

  Wound specimen are collected during each surgical intervention (over ~2 weeks)

• Wound Size

  Size of the pyoderma wound (mm)

  ~6 months (post-op weeks 1, 2, 3, 4, 5, 6, 10, 14, 18, 22; +/- 2 weeks each time in case conflicts arise)

Secondary Outcomes (2)

• Infection

  ~6 months (post-op weeks 1, 2, 3, 4, 5, 6, 10, 14, 18, 22; +/- 2 weeks each time in case conflicts arise)

• Pain Level

  ~6 months (post-op weeks 1, 2, 3, 4, 5, 6, 10, 14, 18, 22; +/- 2 weeks each time in case conflicts arise)

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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.

Biological: Dehydrated human amnion/chorion membrane

Interventions

Dehydrated human amnion/chorion membrane BIOLOGICAL

Dehydrated human amnion/chorion membrane (dHACM) has been commercially available for nearly 15 years. dHACM has been shown to elute growth factors including platelet-derived growth factors, fibroblast growth factors (PDGF), fibroblast growth factors (FGF), transforming growth factor beta 1 (TGF-β1), epidermal growth factor (EGF), vascular endothelial growth factor (VEGF), and placental growth factor (PlGF). Additionally, dHACM exerts immunomodulatory effects by releasing anti-inflammatory interleukins and factors which help regulate the matrix metalloproteinase (MMP) activity. Furthermore, dHACM has also been shown to stimulate mesenchymal stem cell migration and recruitment. dHACM is routinely utilized in the management of chronic wounds including diabetic ulcer and venous ulcers.

Also known as: EpiFix, dHACM

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead

Study Sites (3)

LSU Healthcare Network Clinic

Metairie, Louisiana, 70006, United States

Location

University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Ochsner Baptist Medical Center

New Orleans, Louisiana, 70115, United States

Location

Related Publications (2)

• Maverakis E, Marzano AV, Le ST, Callen JP, Bruggen MC, Guenova E, Dissemond J, Shinkai K, Langan SM. Pyoderma gangrenosum. Nat Rev Dis Primers. 2020 Oct 8;6(1):81. doi: 10.1038/s41572-020-0213-x.

  PMID: 33033263 BACKGROUND

• Koob TJ, Rennert R, Zabek N, Massee M, Lim JJ, Temenoff JS, Li WW, Gurtner G. Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Int Wound J. 2013 Oct;10(5):493-500. doi: 10.1111/iwj.12140. Epub 2013 Aug 1.

  PMID: 23902526 BACKGROUND

Related Links

• EpiFix Information

MeSH Terms

Conditions

Pyoderma Gangrenosum

Condition Hierarchy (Ancestors)

Pyoderma; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Skin Ulcer

Study Officials

• Alison Smith, MD, PhD

  Louisiana State University Health Sciences Center - New Orleans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor of Surgery

Study Record Dates

• First Submitted: September 11, 2021
• First Posted: November 15, 2021
• Study Start: June 2, 2021
• Primary Completion: November 18, 2024
• Study Completion: November 18, 2024
• Last Updated: October 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)