Pyoderma Gangrenosum

Researchers are evaluating whether a medicine called spesolimab can help adults with ulcerative pyoderma gangrenosum (PG), a skin condition that causes ulcers. The main goal is to see if spesolimab can lead to the complete closure of PG ulcers. This phase 3 trial includes adults with at least one ulcer measuring between 5 cm² and 80 cm², requiring systemic therapy. The study is sponsored by Boehringer Ingelheim and involves a randomized, double-blind design.

Researchers are conducting a study called Acutelines, a large data and biobank project at the University Medical Center Groningen in the Netherlands. It focuses on patients with a wide range of acute medical conditions who present to the Emergency Department. The goal is to improve how acute diseases are recognized and treated, understand their outcomes, and support personalized medicine by collecting detailed clinical data, imaging, and biomaterials over time. Participants have their medical information, including demographics, health status, medical history, vital signs, diagnostic tests, and treatments, systematically collected. Biomaterials such as blood, urine, feces, and hair are gathered from patients who meet certain severity criteria. Data collection occurs during hospital admission, including continuous monitoring, and continues with follow-ups at 3 months, 1 year, 2 years, and 5 years after the initial emergency visit. Throughout the study, various assessments are performed, such as quality of life, physical functioning, mental health, symptoms, and hospital length of stay. Researchers collect data on mortality and other health outcomes for up to 50 years. The study uses digital tools to automate data capture and integrates information from multiple healthcare sources. Participants will be monitored closely during hospitalization and at scheduled intervals afterward to help improve understanding and treatment of acute diseases.

Researchers are evaluating the effect of adding clindamycin to the usual treatment of skin and soft tissue infections caused by Staphylococcus aureus in patients from Sierra Leone. The study aims to see if this combination leads to faster healing and fewer infection recurrences. These infections can be severe due to toxins produced by the bacteria, and clindamycin is believed to reduce these toxins. The trial compares standard treatment, usually involving anti-staphylococcal penicillin with or without surgery to drain infection, to the same treatment plus clindamycin. Clindamycin is given either orally or intravenously for 7 days, with dosing adjusted by weight. Participants receive either the standard care alone or the standard care plus clindamycin, and the study is open-label, meaning both patients and doctors know which treatment is given. Participants will be adults with confirmed Staphylococcus aureus skin infections who require systemic therapy. They will be monitored for clinical cure at 7 and 14 days, changes in inflammation, symptom resolution time, possible side effects, microbiological failure, and infections returning over 6 months. Follow-up visits may occur during hospital admission or at home, and safety and treatment outcomes will be carefully tracked throughout the study period.

Researchers are evaluating the use of indocyanine green (ICG) angiography to identify skin areas at risk of necrosis during oncoplastic surgery or skin-sparing mastectomy in women with breast cancer or at high risk for breast cancer. Skin necrosis is a serious complication that can delay further treatment, require additional surgery, and negatively impact cosmetic outcomes and quality of life. This study aims to determine the sensitivity, specificity, and predictive values of ICG angiography in predicting postoperative complications. The study involves women undergoing oncoplastic breast-conserving surgery or skin/nipple-sparing mastectomy with immediate breast reconstruction using a prepectoral implant. ICG angiography will be performed at three key surgical points: before starting the procedure to visualize vascular anatomy, after breast tissue removal to assess flap viability, and after implant placement and wound closure. The SPY System with SPY-Q software will be used to capture these images. Participants will be monitored for postoperative complications up to one month after surgery. Researchers will assess vascularity before surgery, surgical planning, and intraoperative timing. The main outcomes include the accuracy of ICG angiography during surgery and its ability to predict postoperative complications. This observational study will help establish the value of ICG angiography in surgical decision-making and improving patient outcomes.

Researchers are investigating the genetic causes of rare neutrophil-mediated inflammatory skin diseases (NMID), which are severe conditions characterized by inflammation, pain, and skin damage that can affect quality of life and may be fatal. This study aims to identify rare mutations linked to these diseases using advanced genome sequencing techniques, mainly whole exome sequencing, and to examine the expression levels of known inflammatory proteins in skin samples. The research focuses on the genetic background of NMID to better understand their origins. The study involves analyzing biological samples from various groups. These include 600 samples from NMID patients stored in biobanks, about 50 archived skin samples collected before 2014 for RNA and protein analysis, 2,700 anonymized control genomes and 150 control samples for proteomics, and up to 20 fresh skin samples from healthy volunteers. Researchers use methods such as DNA and RNA extraction, immunostaining, imaging techniques, cell culture, and protein analysis with ELISA and Western Blot. Participants contribute biological material such as blood, saliva, and skin samples that will be analyzed using standardized laboratory methods including Nanostring, RNA sequencing, qRT-PCR, proteomics assays, immunohistochemistry, flow cytometry, and imaging mass cytometry. The main outcome measured is the number of rare protein-coding gene variants related to NMID. Secondary outcomes include detailed protein and immune cell assessments. The study does not involve treatment but focuses on collecting and analyzing data to improve understanding of these skin diseases.

Researchers are evaluating the short-term and long-term effects of guselkumab treatment in adults with pyoderma gangrenosum (PG), a skin condition characterized by painful ulcers. This Phase II open-label study involves 17 adult participants diagnosed with PG through clinical, histological, and laboratory assessments. The study aims to understand how guselkumab works alongside prednisone in managing PG over several months. Participants will receive 100 mg of guselkumab injected under the skin every 4 weeks for 28 weeks. Alongside this, they will take a stable daily dose of prednisone starting at 20 mg, which will be gradually reduced based on a specific plan. The study includes follow-up visits lasting until week 40, allowing researchers to observe both immediate and lasting treatment effects. During the study, participants will undergo skin biopsies at the beginning and at week 32, with an option for additional biopsies at week 16. They will be monitored through clinical assessments, laboratory tests, and various measures including ulcer healing, ulcer size reduction, skin pain levels, physical function, and quality of life. Researchers will also track any treatment failures and ulcer recurrence up to week 40, ensuring thorough evaluation of safety and effectiveness over time.

Researchers are evaluating the safety, tolerability, and effectiveness of stem cell therapy for treating a variety of acute and chronic conditions. This multi-site, multi-arm study focuses on regenerative treatments using amniotic and umbilical cord stem cell rich tissue. The study covers conditions including autoimmune diseases, cardiovascular disorders, diabetes complications, integumentary diseases, musculoskeletal disorders, neurological and neurodegenerative disorders, pulmonary disorders, sexual dysfunction, urologic disorders, and viral illnesses. The goal is to measure improvements based on validated quality of life and condition-specific tools. Participants will receive injections of PrimePro™ or PrimeMSK™ stem cell products administered through condition-specific routes. Each study arm targets a particular group of conditions to compare outcomes against established research. The treatments are given once with follow-up visits planned to assess changes over time. No placebo or control group is used, and the study is non-randomized with open-label participation. During the study, participants will undergo various assessments such as the 36-Item Short Form Survey (SF-36) for quality of life, condition-specific questionnaires like the DASH for arm and shoulder disabilities, IIEF-5 for erectile function, clinical COPD questionnaire, MMSE for mental state, O'Leary/Sant questionnaire for interstitial cystitis, Oswestry Low Back Pain Disability Questionnaire, and WOMAC for osteoarthritis. Follow-up evaluations occur at 6 and 12 months after treatment to monitor progress. The study includes safety monitoring and requires participants to be available for follow-up visits over this time frame.

Researchers are investigating how certain drugs prescribed to children and young adults act within their bodies. The goal is to find the safest and most effective doses for these understudied drugs given as part of standard medical care. This observational study focuses on pharmacokinetics (PK), including how drugs are absorbed, distributed, metabolized, and eliminated, with special attention to participants with conditions such as COVID-19 and Down Syndrome. Participants include children and young adults under 21 years who are either prescribed drugs of interest by their healthcare providers or have tested positive for SARS-CoV-2 within 60 days before enrollment. The study collects bodily fluid samples, like whole blood and effluent samples, to analyze drug behavior. Data collection lasts up to 90 days from consent, extended to 210 days for participants with Down Syndrome at designated sites. During the study, participants undergo PK sampling to measure various drug-related factors such as clearance, volume of distribution, elimination rate, half-life, absorption rate, maximum concentration, and time to reach maximum concentration. Researchers gather data at intervals up to 90 or 210 days, depending on participant status. The study monitors safety and drug effects without altering prescribed treatments, aiming to better understand drug profiles in pediatric and young adult populations.

Researchers are evaluating two methods for managing postoperative pain in patients undergoing thoracoscopic esophagectomy: thoracic paravertebral block (TPVB) with liposomal bupivacaine and epidural block with standard bupivacaine. The study aims to compare the overall benefit of analgesic score (OBAS) three days after surgery. This trial addresses the need for effective pain control while considering potential drawbacks of epidural analgesia, such as hypotension and rare neurological complications. Patients will be randomly assigned to one of two groups. The experimental group receives ultrasound-guided TPVB injections of liposomal bupivacaine at multiple thoracic paravertebral spaces, followed by patient-controlled intravenous analgesia (PCIA) using sufentanil. The control group is treated with an epidural block at T6-T8 and patient-controlled epidural analgesia (PCEA) with sufentanil and bupivacaine hydrochloride. Rescue analgesics include acetaminophen or NSAIDs for mild pain and tramadol for more severe pain, with doses adjusted by the acute pain service team. Participants will be closely monitored for pain scores using visual analog scales, opioid consumption, mean arterial pressure, and hospital stay duration. Pain relief assessments and questionnaires are completed during the first three postoperative days. The study is triple-blinded and involves continuous evaluation of safety and analgesic benefit. Total in-hospital monitoring averages about ten days, with follow-up on analgesic outcomes and recovery progress.

Researchers are evaluating the effectiveness of platelet rich fibrin (PRF) combined with topical antibiotics or antiseptics for treating infected chronic wounds. This randomized controlled trial compares three different PRF treatments to an active silver gauze wound dressing, aiming to provide evidence on how PRF works alone and when mixed with antimicrobial compounds. The study focuses on patients with infected chronic venous ulcers and excludes those with certain severe conditions or untreated diabetes. The trial has four treatment groups: PRF mixed with amikacin and teicoplanin sprayed onto the wound, PRF with placebo saline spray, PRF combined with polyhexanide and macrogolol spray, and a silver gauze dressing as the control. Participants receive treatment for 56 days, with wound surface area measured at baseline, day 28, and day 56. Infection parameters such as C-reactive protein and leukocyte counts are monitored weekly, and systemic antimicrobial therapy is started if needed based on specialist evaluation. Participants will visit regularly for wound assessments, blood tests, and monitoring of infection signs. Researchers will evaluate wound area reduction after 56 days as the primary outcome, along with secondary outcomes including the need for systemic antibiotics, time to wound sterility, and presence of drug-resistant bacteria. The study includes close monitoring of infection status and safety measures throughout the treatment period.