Skin Infection

Many people experience wounds that do not heal well or take a long time to heal, including both chronic and acute wounds. This research aims to study the effects of 4-aminopyridine 4-AP, a drug currently used in neurological conditions, to see if it can help speed up wound healing in healthy adults. Previous animal studies showed promising results with faster healing and no adverse effects, making it important to evaluate 4-APs role in human wound repair. Participants in this study will be randomly assigned to receive either 4-aminopyridine capsules or placebo capsules taken every 12 hours. The treatment period lasts for 6 weeks, during which researchers will monitor wound healing progress. The study includes a phase where participants receive either the active drug or placebo to compare effects on skin integrity and wound closure. During the study, participants will have a skin punch biopsy wound that will be monitored for healing over 6 weeks. Researchers will assess the return of skin integrity, wound closure, and hair growth at the biopsy site. Participants must attend scheduled follow-up visits and may be asked to provide wound photographs. The study also tracks safety and tolerability, ensuring participants are able to report any sensory or motor changes. Total participation is about 6 weeks with regular evaluations.

Researchers are evaluating the progress of chronic venous leg ulcers in adults using a non-bordered foam dressing. This prospective, open, multi-center, interventional study aims to track wound healing over a 6-week period or until the wound heals. The study focuses on venous leg ulcers that produce moderate to large amounts of fluid and includes 20 participants across centers in the US and Canada. All participants will use the ALLEVYN Non-Adhesive foam dressing as the primary absorbent dressing. This device combines a breathable top film, a highly absorbent foam core, and a non-adhesive wound contact layer designed for comfort and optimal moist wound healing. The dressing will be worn continuously and changed every week during the treatment period. Participants will attend seven visits a baseline visit followed by weekly visits up to six weeks. At each visit, wound progress will be assessed by measuring wound size and evaluating wound condition. Researchers will also monitor pain, comfort, quality of life, dressing performance, and safety throughout the study. The main outcome measured is wound progress from baseline to last follow-up, with additional assessments including wound area reduction, tissue changes, exudate characteristics, skin condition, and adverse events.

Researchers are evaluating the progress of chronic wounds, specifically venous leg ulcers VLU and diabetic foot ulcers DFU, using an absorbent dressing called Mepilex Up. This study is a prospective, open, multi-center, interventional trial designed to observe wound healing over a period of up to six weeks. The goal is to track changes in wound area and condition while participants receive treatment according to local standards of care. Participants will use the Mepilex Up dressing, which is a soft, silicone-based absorbent foam dressing designed to manage wound exudate and protect the skin. The dressing will be applied as the primary dressing and changed weekly for up to six weeks or until the wound heals. The study includes seven visits a baseline visit followed by weekly visits to monitor wound healing and dressing performance. During each visit, researchers will assess wound progress through measurements and evaluations of wound area, volume, tissue quality, exudate, and skin condition. Participants will report on pain, comfort, and quality of life related to wound care. Safety will be monitored at all visits. The total treatment period is a maximum of 44 days or until healing occurs, with detailed tracking of dressing wear time, wound changes, and any adverse events.

This research observes children who took part in the TEMPO clinical trial during their first year of life to understand if their early feeding patterns affect the development of allergies or infections in childhood. The study follows these children up to 7.5 years to gather information on allergic symptoms, infections, and related medical care. It is an observational study without additional treatments or interventions. Participants complete self-administered digital questionnaires every three months using a smartphone, tablet, or computer. These questionnaires collect data on allergies, infections, medication use, medical device use, hospitalizations, and emergency room visits. The study is entirely virtual and decentralized, allowing families to participate remotely. Throughout the study, parents provide information via regular online questionnaires, helping researchers track their childs health over time. The main measurements include parent-reported symptoms, medication or device use, and healthcare visits related to allergies and infections. The study runs until March 2029 and includes children aged 3 to 10 years who completed the original TEMPO study.

Researchers are evaluating whether the Xperience surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections following implant-based breast reconstruction in women aged 18 and older. The study also aims to compare the safety and overall surgical outcomes between Xperience and povidone-iodine. This clinical trial is a randomized controlled trial sponsored by the University of North Carolina, Chapel Hill. Participants will be randomly assigned to receive either the Xperience solution or the dilute povidone-iodine solution during their bilateral implant-based breast reconstruction surgery. Xperience will be applied twice during the procedure, soaking both the mastectomy pockets and implants with specific volumes and dwell times before insertion. The povidone-iodine solution will be applied similarly. Surgical site closure will follow standard procedures for all participants. During the study, participants will have regular post-operative check-ups to monitor for infections and other complications. Researchers will collect data on the rates of surgical site infections, premature implant removal due to infection, and non-infectious post-surgical complications within 90 days after implant placement. The study will monitor safety and overall outcomes through these evaluations, with participation lasting through this 90-day post-surgery period.

Researchers are evaluating the safety, tolerability, and how the body processes pharmacokinetics single and multiple intravenous doses of a drug called BWC0977 in healthy adult volunteers. This Phase 1 study involves a total of 64 healthy adults aged 18 to 55 years and is designed as a randomized, double-blind, placebo-controlled trial with multiple dose groups. The study focuses on measuring any treatment-emergent adverse events and serious adverse events to understand the drugs safety profile. Participants will be divided into two main groups single ascending dose SAD and multiple ascending dose MAD cohorts. In the SAD phase, volunteers receive one intravenous infusion of BWC0977 or placebo over 2 hours at doses of 750 mg or 1500 mg. In the MAD phase, participants receive multiple intravenous infusions of BWC0977 or placebo over 30 minutes to 2 hours daily for 7 to 10 consecutive days. Dose levels will increase sequentially based on safety and tolerability data collected during the study. During the study, participants will undergo various assessments including physical exams, vital signs, ECGs, laboratory tests, and blood sampling at specific times before, during, and after infusions to monitor safety and measure drug levels in the body. Researchers will track adverse events for up to 8 days after single dosing and up to 16 days after multiple dosing. Volunteers must comply with study visits and requirements throughout the trial, which lasts until August 2026.

Researchers are gathering detailed real-world information on people with chronic wounds and ulcers to better understand their medical journey and treatment outcomes. This observational registry collects data from over 1,400 healthcare providers across the USA and Puerto Rico using a specialized electronic health record system. It includes all major wound types such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, arterial ulcers, surgical wounds, traumatic wounds, and inflammatory ulcers. Participants receive care as usual from their clinicians, who use standard and advanced wound treatments like specialized dressings, compression therapy, offloading devices, cellular and tissue-based products, negative pressure therapy, ultrasound therapy, topical oxygen, hyperbaric oxygen, growth factors, debridement, and topical antibiotics. Data on treatment practices, wound characteristics, patient health conditions, and complications are collected continuously during routine care. Patients may be followed for over five years to track long-term outcomes. During the study, researchers collect information on patient demographics, wound details, treatment methods, visit frequency, and complications. They monitor healing progress, amputations, deaths, wound recurrence, hospitalizations, and other outcomes. The registry uses a wound healing index to adjust for risk and supports quality improvement and research by linking clinical data with insurance claims for comprehensive analysis. This ongoing effort helps to better understand wound healing and treatment effectiveness in everyday healthcare settings.

Researchers are evaluating the safety of Amicidin- topical solution when applied directly into infected surgical or traumatic wounds during surgery. This Phase 1 trial aims to determine if Amicidin- is safe enough for larger trials, whether it is absorbed into the bloodstream from local wound application, and how easy it is for surgeons to use. The study compares standard wound care alone with standard care combined with Amicidin- to monitor for any drug-related side effects. Participants will be assigned in three sequential groups, with about 44 patients total. Within each group, participants are randomly assigned to receive either standard care alone or standard care plus Amicidin- topical solution in different doses and application methods, such as 15 mL or 50 mL applied just before wound closure, with or without rinsing with saline. The treatment is applied during surgery to manage infected wounds. During the study, participants will be monitored for up to 30 days to observe any adverse events related to the treatments. Researchers will also measure how much of the drug enters the bloodstream during the first three days. Safety assessments, including clinical evaluations and adverse event tracking, will guide understanding of the treatments effects. Participants will be followed closely through this period to collect all necessary data.

Researchers are evaluating the safety, tolerability, and pharmacokinetics of ATB1651, a topical solution, in adults with mild to moderate onychomycosis, a fungal infection of the toenails. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to assess how well ATB1651 works and how safe it is when applied to the great toenail. The study plans to enroll up to 120 participants divided into multiple sequential cohorts, with an optional fourth cohort, to test different dosing regimens and strengths of the drug. Participants will be assigned to receive either ATB1651 or a placebo in a ratio of 51 within each cohort. Cohorts 1 to 3 will receive a 3% ATB1651 solution applied once or twice daily for 12 to 20 weeks, followed by a follow-up period lasting 16 to 24 weeks. An optional Cohort 4 may receive a 5% ATB1651 solution once daily for 12 weeks with a 24-week follow-up. Dosing in later cohorts depends on safety reviews from earlier groups. During the study, participants will visit regularly for safety assessments, blood tests to measure drug levels, and evaluations of their toenail condition. Researchers will track the complete cure rate of onychomycosis over up to 252 days and monitor for any side effects. The study will also measure various pharmacokinetic parameters such as maximum plasma concentration and elimination rates. Participant involvement includes applying the treatment daily and attending follow-up visits to assess long-term outcomes and safety.

Researchers are evaluating the effectiveness and safety of baricitinib for treating severe or very severe alopecia areata, a form of hair loss, in children aged 6 to less than 18 years. This Phase 3 clinical trial aims to better understand how baricitinib works in this young population with this condition. The study is sponsored by Eli Lilly and Company and focuses on pediatric patients with a history of severe alopecia areata. Participants are randomly assigned to receive either a high dose or low dose of baricitinib taken orally, or a placebo. The study is divided into four periods a 5-week screening period to determine eligibility, a 36-week double-blind treatment period where participants receive the assigned study medication, an approximately 2-year long-term extension period for ongoing treatment, and a 4-week post-treatment follow-up. Some participants may continue treatment for up to a total of 180 weeks if eligible after the extension period. Throughout the study, participants undergo regular assessments including measurement of hair loss severity using the Severity of Alopecia Tool SALT score, patient-reported outcomes related to scalp hair and eyebroweyelash hair loss, and quality of life questionnaires. Safety and pharmacokinetics of baricitinib are also monitored. The primary outcome is to measure the percentage of participants achieving a SALT score of 20 or less by week 36. Participants receive careful monitoring during and after treatment, with the total study duration extending over multiple years.