View clinical trials related to Pyoderma Gangrenosum.
Filter by:The purpose of this research study is to assess the feasibility of using spesolimab in participants with moderate to severe pyoderma gangrenosum. Pyoderma gangrenosum is a rare, inflammatory, autoimmune condition which results in ulceration of skin. The study will also investigate the body's immune response to the spesolimab (when the body detects and defends itself against substances that appear unknown and harmful).
Pyoderma gangrenosum (PG) is a chronic inflammatory condition with severe painful ulcers. We hypothesize that Platelet-rich plasma(PRP) therapy derived from patient's own blood has a high concentration of endogenous growth factors, which will activate the wound-healing cascade stimulating formation of new blood vessels and collagen in PG ulcers.The goal of this study is to evaluate the efficacy and safety of autologous Platelet rich Plasma(PRP) therapy for the treatment of chronic Pyoderma Gangrenosum(PG). Researchers will also compare the efficacy of PRP therapy when used as a topical solution versus injections in and around the target ulcer/s.
A randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to investigate efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma gangrenosum
The main goal of this study is to see if the study drug called "Deucravacitinib" is safe and effective in treating people with pyoderma gangrenosum (PG).
Rationale: Pyoderma gangrenosum (PG) is a rare auto-inflammatory neutrophilic dermatosis characterized by a spectrum of clinical presentations with variable courses. Diagnosis and management are challenging in PG. Treatment, including systemic prednisone and anti-TNF therapy, is directed towards reducing pain and associated inflammation that leads to ulceration. Positive effects of hyperbaric oxygen (HBO) therapy have been reported in small case series. Objective: To investigate the therapeutic efficacy of hyperbaric oxygen on top of standard wound care and regular anti-inflammatory treatment in patients with pyoderma gangrenosum wounds. Study design: Prospective cohort study with a follow-up to one year. Study population: 15 adult patients with pyoderma gangrenosum refractory to standard-prednisone or anti-TNF therapy will be included for hyperbaric oxygen therapy. Patients with pyoderma gangrenosum that are eligible but reject hyperbaric oxygen treatment will serve as controls. In total the investigators will include 30 patients. Intervention (if applicable): 30 sessions of HBO therapy will be applied on top of regular wound care and systemic anti-inflammatory treatment. Controls will be treated with regular wound care and anti-inflammatory treatment. Main study parameters/endpoints: Wound healing time (time to wound closure). PG wounds will be measured at baseline using a validated, objective 3D photographical wound measurement tool, and again after 3 and 6 weeks at the end of HBO treatment and after 3 months. Patients will take weekly photographs at home using a 2D validated measurement tool of the wounds. Secondary parameters: Alteration in the expression of markers of inflammation by micro-biopsies of wound edges, non-invasive mitochondrial O2 measurements at wound edges, blood neutrophil count and patient-reported outcomes like WOUND-Q, pain on NR scale and treatment satisfaction scores. Assessment concerning laboratory findings will be done at baseline before starting the trial, at 3 weeks and at week 6 at the end of HBO treatment. Patient reported outcomes, WOUND-Q will be measured at baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months. Mean NRS scores will be recorded once a week.
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.
An Open-Label, Proof-Of-Concept, Study of Baricitinib for the Treatment of Pyoderma Gangrenosum
Phase 0/1 local application of the monoclonal antibody (Mab) sB24M in patients with purulent pyoderma (chronic ulcerative pyoderma) by injection into the affected areas. Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through CD47 / TNF-α Axis promotes epithelialization of damaged tissue.
The investigators hypothese that Janus kinase/signal transduction and activator of transcription (JAK/STAT) signaling pathway play a key role in pathophysiology of pyoderma gangrenosum (PG). In this study JAK/STAT signaling pathway will be investigated in the skin biopsies of PG patients
Pyoderma Gangrenosum (PG) is a rapidly progressive disease and presents as painful, single or multiple lesions, with several clinical variants, in different locations, with a nonspecific histology, which makes the diagnosis challenging and often delayed. The main objective of this study is to estimate the incidence proportion of all the infection reported as adverse drug reaction (ADR) of Humira with PG participants. Humira is the only drug approved for the treatment of Pyoderma Gangrenosum (PG) in Japan. Approximately 60 adult participants with PG at approximately 60 sites in Japan. Participants will receive injectable Humira (Adalimumab) as prescribed by the physician prior to enrolling in this study. There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and by verbal interview.