Pyoderma GangrenosumPhase 4NCT05120726
A Novel Therapeutic Treatment of Pyoderma Gangrenosum
A Phase 4 study testing Dehydrated human amnion/chorion membrane in people with Pyoderma Gangrenosum, run by Louisiana State University Health Sciences Center in New Orleans at 3 sites in United States.
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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pyoderma Gangrenosum
- What is being tested?
- Dehydrated human amnion/chorion membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Jun 2021to 18 Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with pyoderma gangrenosum
- patients over 18 years of age
Who cannot join
- members of vulnerable populations (pregnant women and prisoners)
- patients less than 18 years of age
Trial locations and contacts
3 sites in 1 country.
United States3 sites
LSU Healthcare Network Clinic
Metairie, Louisiana, 70006
University Medical Center
New Orleans, Louisiana, 70112
Ochsner Baptist Medical Center
New Orleans, Louisiana, 70115
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Pyoderma Gangrenosum
- Being tested
- Dehydrated human amnion/chorion membrane
- Keywords
- Pyoderma Gangrenosum, EpiFix, dehydrated human amnion/chorion membrane
- Medical subject headings
- Pyoderma Gangrenosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dehydrated human amnion/chorion membraneBiological
Also called EpiFix, dHACM
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Dehydrated human amnion/chorion membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene Measurements
Identifying genes or genetic pathways that are specifically targeted by treatment of a wound with dehydrated human amnion/chorion membrane (dHACM)
Measured: Wound specimen are collected during each surgical intervention (over ~2 weeks)
Wound Size
Size of the pyoderma wound (mm)
Measured: ~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
Yes/No
Measured: ~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
Scale (0-10) (0 = no pain, 10 = worst pain ever experienced)
Measured: ~6 months (post-op weeks 1, 2, 3, 4, 5, 6, 10, 14, 18, 22; +/- 2 weeks each time in case conflicts arise)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start2 Jun 2021
- Primary completion18 Nov 2024
- Study completion18 Nov 2024
Why it stopped: The study was closed prior to completion because of difficulties in recruiting eligible participants. Despite outreach efforts, enrollment remained insufficient to meet anticipated study endpoints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pyoderma GangrenosumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison A. Smith, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Alison Smith, MD, PhD, Principal investigator, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120726
- Sponsor's protocol ID
- IRB: #1579
- Status last verified
- May 2025
- First submitted
- 11 Sep 2021
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33033263Koob 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.
PubMed 23902526
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Therapeutic Treatment of Pyoderma Gangrenosum
- ClinicalTrials.gov ID
- NCT05120726
- Acronym / sponsor ID
- IRB: #1579
- Conditions
- Pyoderma Gangrenosum
- Keywords
- Pyoderma Gangrenosum, EpiFix, dehydrated human amnion/chorion membrane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was closed prior to completion because of difficulties in recruiting eligible participants. Despite outreach efforts, enrollment remained insufficient to meet anticipated study endpoints.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Biological: Dehydrated human amnion/chorion membranePatient'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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients diagnosed with pyoderma gangrenosum
- patients over 18 years of age
Key exclusion criteria (2 listed)
- members of vulnerable populations (pregnant women and prisoners)
- patients less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dehydrated human amnion/chorion membraneAlso: EpiFix, dHACMDehydrated 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. | Biological | Treatment Arm |
Primary outcome
Gene Measurements
Time frame: Wound specimen are collected during each surgical intervention (over ~2 weeks)
Identifying genes or genetic pathways that are specifically targeted by treatment of a wound with dehydrated human amnion/chorion membrane (dHACM)
Wound Size
Time frame: ~6 months (post-op weeks 1, 2, 3, 4, 5, 6, 10, 14, 18, 22; +/- 2 weeks each time in case conflicts arise)
Size of the pyoderma wound (mm)
2 secondary outcomes
Infection
Time frame: ~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
Time frame: ~6 months (post-op weeks 1, 2, 3, 4, 5, 6, 10, 14, 18, 22; +/- 2 weeks each time in case conflicts arise)
Results and safety
The study was stopped early (reason given: The study was closed prior to completion because of difficulties in recruiting eligible participants. Despite outreach efforts, enrollment remained insufficient to meet anticipated study endpoints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Background: PubMed 33033263Maverakis 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.
- Background: PubMed 23902526Koob 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.
- EpiFix InformationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Smith, MD, PhD principal investigator
Louisiana State University Health Sciences Center in New Orleans
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dehydrated human amnion/chorion membrane in people with Pyoderma Gangrenosum, run by Louisiana State University Health Sciences Center in New Orleans at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was closed prior to completion because of difficulties in recruiting eligible participants. Despite outreach efforts, enrollment remained insufficient to meet anticipated study endpoints.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene Measurements (time frame: Wound specimen are collected during each surgical intervention (over ~2 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05120726, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.