A Novel Therapeutic Treatment of Pyoderma Gangrenosum
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05120726 |
|
Recruitment Status :
Recruiting
First Posted : November 15, 2021
Last Update Posted : November 15, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pyoderma Gangrenosum | Biological: Dehydrated human amnion/chorion membrane | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Novel Therapeutic Treatment of Pyoderma Gangrenosum |
| Actual Study Start Date : | June 2, 2021 |
| Estimated Primary Completion Date : | August 1, 2022 |
| Estimated Study Completion Date : | August 1, 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Treatment Arm
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
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.
Other Names:
|
- 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)
- 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) ]Yes/No
- 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) ]Scale (0-10) (0 = no pain, 10 = worst pain ever experienced)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients diagnosed with pyoderma gangrenosum
- patients over 18 years of age
Exclusion Criteria:
- members of vulnerable populations (pregnant women and prisoners)
- patients less than 18 years of age
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05120726
| Contact: Alison Smith, MD, PhD | 504-903-9009 | asmi60@lsuhsc.edu |
| United States, Louisiana | |
| LSU Healthcare Network Clinic | Recruiting |
| Metairie, Louisiana, United States, 70006 | |
| Contact: Frank Lau, MD 504-412-1240 flau@lsuhsc.edu | |
| Contact: Alison Smith, MD, PhD 504-903-9009 asmi60@lsuhsc.edu | |
| Principal Investigator: Alison Smith, MD, PhD | |
| Sub-Investigator: Frank Lau, MD | |
| University Medical Center | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| Contact: Alison Smith, MD, PhD 504-903-9009 asmi60@lsuhsc.edu | |
| Contact: Frank Lau, MD 504-412-1240 flau@lsuhsc.edu | |
| Principal Investigator: Alison Smith, MD, PhD | |
| Sub-Investigator: Frank Lau, MD | |
| Ochsner Baptist Medical Center | Enrolling by invitation |
| New Orleans, Louisiana, United States, 70115 | |
| Principal Investigator: | Alison Smith, MD, PhD | Louisiana State University Health Sciences Center - New Orleans |
Documents provided by Alison A. Smith, Louisiana State University Health Sciences Center in New Orleans:
Publications:
| Responsible Party: | Alison A. Smith, Assistant Clinical Professor of Surgery, Louisiana State University Health Sciences Center in New Orleans |
| ClinicalTrials.gov Identifier: | NCT05120726 |
| Other Study ID Numbers: |
IRB: #1579 |
| First Posted: | November 15, 2021 Key Record Dates |
| Last Update Posted: | November 15, 2021 |
| Last Verified: | November 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
|
Pyoderma Gangrenosum EpiFix dehydrated human amnion/chorion membrane |
|
Pyoderma Pyoderma Gangrenosum Skin Diseases Skin Diseases, Vascular Skin Ulcer |