EpiFix for Pyoderma Gangrenosum

No longer recruiting at 2 trial locations

Overseen By Alison Smith, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Louisiana State University Health Sciences Center in New Orleans

Disqualifiers: Pregnant, Prisoners, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, EpiFix (a dehydrated human amnion/chorion membrane), to heal wounds from pyoderma gangrenosum, a painful and chronic skin condition. Researchers aim to determine if EpiFix improves healing when applied during surgery, followed by a skin graft. The trial includes multiple check-ups to monitor healing and collect data. Individuals diagnosed with pyoderma gangrenosum might be suitable candidates for this study. As a Phase 4 trial, EpiFix is already FDA-approved and proven effective, and this research seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial staff during the pre-screening process.

What is the safety track record for EpiFix?

Studies have shown that EpiFix, a treatment derived from special human tissue, is generally safe and well-tolerated. In one study, patients using this treatment did not encounter major problems, even with serious skin issues. Another report described a patient with pyoderma gangrenosum who successfully used EpiFix alongside other treatments, though some pain was noted. Overall, research suggests that EpiFix is a safe option for treating challenging skin conditions like pyoderma gangrenosum. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for pyoderma gangrenosum, which often involve immunosuppressants like corticosteroids or ciclosporin, EpiFix uses a dehydrated human amnion/chorion membrane. This unique material is packed with growth factors and proteins that can help promote faster and more effective wound healing. Researchers are excited about EpiFix because it targets the wound environment directly, potentially leading to better healing outcomes and reducing dependency on systemic medications, which can have significant side effects. Additionally, EpiFix's integration with skin grafts could enhance tissue regeneration, offering a novel approach to managing this challenging condition.

What evidence suggests that EpiFix might be an effective treatment for pyoderma gangrenosum?

Research has shown that EpiFix, a special type of dried human tissue, can help treat pyoderma gangrenosum, a chronic skin ulcer. In this trial, participants will receive surgical treatment of their pyoderma gangrenosum wounds with EpiFix. One study found it effective for patients who did not improve with usual treatments. Specifically, patients experienced better wound healing with EpiFix, and in some cases, it also reduced pain. Overall, EpiFix appears to be a promising option for managing these persistent skin ulcers. ^{2 3 4 6 7}

Who Is on the Research Team?

Alison Smith, MD, PhD

Principal Investigator

Louisiana State University Health Sciences Center - New Orleans

Are You a Good Fit for This Trial?

This trial is for adults over 18 with pyoderma gangrenosum, a rare skin condition causing painful ulcers. Participants must be pre-screened in clinic, reviewing medical history and current medications, along with a physical exam of the wounds.

Inclusion Criteria

I have been diagnosed with pyoderma gangrenosum.

I am over 18 years old.

Exclusion Criteria

Members of vulnerable populations (pregnant women and prisoners)

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Pre-Screening

Pre-screening process includes medical history review, co-morbid medical problems, home medications, and physical exam of the wounds

1 week

1 visit (in-person)

Treatment

Initial surgery with EpiFix treatment followed by a second surgery for skin grafts; wound samples collected for genetic analysis

2 weeks

2 surgeries (in-person)

Post-Surgery Monitoring

Routine clinic visits to monitor wound healing, take measurements, photos, and evaluate pain and infection

6 months

Weekly visits initially, then every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EpiFix

Trial Overview The study tests EpiFix (dehydrated human amnion/chorion membrane) on wound treatment. It involves two surgeries: first to apply EpiFix to the wounds, then a week later to place skin grafts. Wound healing is monitored through regular clinic visits and analysis of genetic information from wound samples.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 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.

EpiFix is already approved in United States for the following indications:

Approved in United States as EpiFix for:

• Wound healing
• Chronic wounds
• Diabetic foot ulcers
• Venous leg ulcers
• Pressure ulcers

Who Is Running the Clinical Trial?

Louisiana State University Health Sciences Center in New Orleans

Lead Sponsor

Trials

123

Recruited

42,400+

Published Research Related to This Trial

A 21-year-old woman developed Pyoderma Gangrenosum (PG) after a caesarean section, which led to severe necrosis and complications, highlighting how PG can mimic infections and delay diagnosis.

High-dose corticosteroids were effective in rapidly treating PG, emphasizing the need for timely recognition to prevent further complications and morbidity from unnecessary surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pseudo-wound infection after a caesarean section: Case report of unrecognized Pyoderma Gangrenosum. van Donkelaar, CE., de Haan, JMH., Lange, JFM., et al.[2021]

In a study of five adult patients with steroid-refractory pyoderma gangrenosum, canakinumab treatment led to significant clinical improvement, with four out of five patients experiencing a decrease in lesion size and three achieving complete remission by week 16.

The results suggest that interleukin-1β is a key factor in the disease's pathology, indicating that canakinumab, which targets this cytokine, may be an effective treatment option for patients who do not respond to steroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canakinumab in adults with steroid-refractory pyoderma gangrenosum. Kolios, AG., Maul, JT., Meier, B., et al.[2019]

Pyoderma gangrenosum (PG) can occur in pregnant women after a caesarean section and may be misdiagnosed as a surgical site infection (SSI), as seen in two cases where patients exhibited wound ulceration despite antibiotic treatment.

In both cases, a skin biopsy confirmed PG, and treatment with oral steroids led to significant improvement, highlighting the importance of accurate diagnosis and appropriate treatment for PG, which differs from that of SSI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incisional pyoderma gangrenosum after caesarean section: Two case reports. Murata, T., Kyozuka, H., Fukuda, T., et al.[2022]

Pyoderma gangrenosum (PG) is a complex skin condition characterized by painful ulcers and is often associated with underlying diseases like inflammatory bowel disease and certain malignancies, making accurate diagnosis crucial to avoid harmful treatments.

While there is no one-size-fits-all treatment for PG, effective management often involves systemic immunosuppressive therapies such as corticosteroids and cyclosporine, with emerging options like TNF-alpha blockers showing promise for difficult cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pyoderma gangrenosum. Conrad, C., Trüeb, RM.[2019]

Pyoderma gangrenosum (PG) is a rare skin condition with an incidence of 3-10 cases per million people per year, often associated with underlying diseases like inflammatory bowel diseases and hematological malignancies, indicating a potential immune system dysregulation.

The condition can be triggered by minor trauma in 20-30% of cases, and while the prognosis is generally good, it can vary significantly based on associated underlying disorders; treatment options include topical steroids for mild cases and systemic therapies like glucocorticoids for severe cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pyoderma gangrenosum: a systematic review. Cozzani, E., Gasparini, G., Parodi, A.[2022]

In a retrospective case series involving 5 patients with pyoderma gangrenosum (PG) whose wounds had not healed for at least 2.5 months despite standard treatments, the application of dehydrated human amnion/chorion membrane (DHACM) led to successful wound closure in all cases.

The study suggests that DHACM could be an effective alternative treatment for PG ulcers that do not respond to conventional therapies, highlighting the need for further formal evaluation of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pyoderma gangrenosum and dehydrated human amnion/chorion membrane: a potential tool for an orphan disease. Alston, D., Eggiman, E., Forsyth, RA., et al.[2022]

Pyoderma gangrenosum (PG) is a rare and painful skin condition that often occurs alongside other diseases, such as inflammatory bowel disease, and is characterized by rapidly progressing ulcers.

Treatment for PG primarily involves systemic corticosteroids and cyclosporin A, with additional options like anti-TNF therapy showing promise, but the prognosis remains unpredictable due to the lack of large-scale clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pyoderma gangrenosum--a review. Wollina, U.[2022]

A 77-year-old woman with refractory pyoderma gangrenosum experienced significant pain relief and wound healing after the application of dehydrated human amnion/chorion membrane (dHACM) allograft, reducing her pain from 10 to 0 within days.

After incorporating dHACM into her treatment plan alongside immunosuppressive therapy, the size of her wound decreased by over 56% within two months, highlighting the potential efficacy of dHACM in managing difficult wounds associated with pyoderma gangrenosum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dehydrated Human Amnion/Chorion Membrane as Adjunctive Therapy in the Multidisciplinary Treatment of Pyoderma Gangrenosum: A Case Report. Snyder, RJ., Ead, J., Glick, B., et al.[2017]

Plasma exchange treatment for pyoderma gangrenosum showed promising results in 3 out of 4 patients, with significant pain relief and healing of lesions after just one session, especially when combined with corticosteroids.

The treatment effectively halted disease progression and reduced the need for surgical interventions, indicating that plasma exchange can be a valuable option for managing this condition, although results may vary among individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pyoderma gangrenosum: treatment with plasma exchange (4 cases)]. Gérard, A., Schooneman, F., Voiriot, P., et al.[2006]

A 30-year-old woman developed chronic, nonhealing ulcers consistent with pyoderma gangrenosum after undergoing surgical biopsies, highlighting the condition's potential to worsen following trauma or surgical intervention.

Treatment with a high-potency topical steroid over 9 weeks led to gradual healing of the ulcers, suggesting that topical steroids can be an effective management option for pyoderma gangrenosum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of postsurgical pyoderma gangrenosum with a high-potency topical steroid. Hawryluk, EB., Penn, SK., Wasko, MC., et al.[2013]

This case series presents the successful use of viable cryopreserved umbilical cord tissue (vCUT) in treating three patients with pyoderma gangrenosum (PG), leading to complete healing of their ulcers.

The findings suggest that vCUT may be an effective adjunctive treatment for managing the challenging wounds associated with PG, which often do not respond well to conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Management of Lower Extremity Pyoderma Gangrenosum With Viable Cryopreserved Umbilical Tissue: A Case Series. Fridman, R., Bar-David, T., Larsen, J., et al.[2021]

Pyoderma gangrenosum is a serious skin condition often linked to underlying diseases like inflammatory bowel disease, and its diagnosis relies on clinical presentation and exclusion of similar conditions.

The most effective treatments include systemic corticosteroids and cyclosporine, with combinations of these and other drugs used for resistant cases, although the overall prognosis remains unpredictable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical management of pyoderma gangrenosum. Wollina, U.[2018]

A 58-year-old woman with biopsy-confirmed pyoderma gangrenosum (PG) experienced rapid progression of painful skin lesions, which were effectively treated with a combination of systemic steroids, topical negative pressure treatments, surgical revision, and partial skin grafting.

After this comprehensive treatment approach, the patient remained pain-free and showed no recurrence of PG for 11 months, indicating the efficacy of the treatment strategy in managing this rare autoimmune condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Topical negative pressure and skin transplantation for the treatment of pyoderma gangrenosum]. Gámiz, RC., Nielsen, AM.[2013]

Pyoderma gangrenosum (PG) is a rare skin condition that can occur in children, with this case being the youngest reported instance at just six months old, associated with chronic recurrent multifocal osteomyelitis (CRMO).

Approximately 50% of PG patients have an underlying systemic disease, with common associations including inflammatory bowel disease and arthritis, highlighting the importance of recognizing PG as a potential indicator of other health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pyoderma gangrenosum in a six-month-old boy. Koturoğlu, G., Vardar, F., Ozkinay, F., et al.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05120726

A Novel Therapeutic Treatment of Pyoderma Gangrenosum We hypothesize that EpiFix (dehydrated human amnion/chorion membrane) will be beneficial in treating patients with pyoderma gangrenosum.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36240792/

Pyoderma gangrenosum and dehydrated human amnion ... This retrospective pilot case series examined the use of DHACM as an alternative wound treatment for PG patients failing standard therapies.

3. magonlinelibrary.com magonlinelibrary.com/doi/10.12968/jowc.2022.31.10.808

Pyoderma gangrenosum and dehydrated human amnion ... This retrospective pilot case series examined the use of DHACM as an alternative wound treatment for PG patients failing standard therapies.

4. researchgate.net researchgate.net/publication/281778648_Dehydrated_Human_AmnionChorion_Membrane_as_Adjunctive_Therapy_in_the_Multidisciplinary_Treatment_of_Pyoderma_Gangrenosum_A_Case_Report

(PDF) Dehydrated Human Amnion/Chorion Membrane as ... A case of a 77year old female with pyoderma gangrenosum treated with dehydrated PM as an adjunct to immunosuppressives reported pain ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/wrr.12503

A comparative outcomes analysis evaluating clinical ... A comparative outcomes analysis evaluating clinical effectiveness in two different human placental membrane products for wound management.

6. jaadcasereports.org jaadcasereports.org/article/S2352-5126(18)30083-3/fulltext

Dehydrated human amnion/chorion membrane allograft as ... In this case series, dHACM allografts were safe and well tolerated with no complications in elderly patients with full-thickness MMS defects for ...

7. jddonline.com jddonline.com/articles/unique-usages-of-dehydrated-human-amnion-chorion-membrane-allografts-in-dermatology-S1545961623P1228X/?_page=4

Unique Usages of Dehydrated Human Amnion Chorion ... Dehydrated human amnion/chorion membrane as adjunctive therapy in the multidisciplinary treatment of pyoderma gangrenosum: a case report. Ostomy Wound ...