Skin Wound

Researchers are evaluating the quality of 3D hand modelization using the EOS imaging system compared to the standard computed tomography (CT) scans. The study focuses on patients who require CT imaging of the hand or wrist to assess the accuracy and potential benefits of the EOS imaging device. Participants will undergo EOS hand imaging, and these images will be compared directly with their standard CT images. The primary goal is to collect and analyze data from both imaging methods at 60 days to determine how well the EOS system performs in creating 3D models of the hand. During the study, participants will have imaging procedures and data collection focused on the hand or wrist area. Researchers will monitor and compare the imaging outcomes from both EOS and CT methods. The total participation duration includes data evaluation at day 60, with no additional treatment or long-term follow-up specified.

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-AP's 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.

Many patients suffer from traumatic burns, and current treatments mainly focus on infection prevention and fluid management without improving the skin's ability to regenerate. This research aims to evaluate the role of 4-aminopyridine (4-AP), a promising agent with a good safety profile, in accelerating burn wound healing in patients with second-degree burns. The study addresses the need for new regenerative treatments that can speed up recovery while allowing existing protocols to continue. Participants will be randomly assigned to receive either 4-aminopyridine capsules (10 mg every 12 hours) or a placebo capsule on the same schedule. This phase 2 study will compare these two groups over a 12-month period to assess the treatment's effect on the healing process. The study uses triple masking to ensure unbiased results. During the study, participants will be monitored for healing rate, skin graft requirements, scar formation, and scar sensitivity over 12 months. They will provide informed consent and attend scheduled follow-up visits where researchers will evaluate wound healing through sensory and motor assessments and calibrated wound photographs. Safety and adherence will be closely tracked to evaluate the treatment's impact and patient outcomes throughout the study period.

Burn injuries can cause long-lasting physical and mental effects due to scarring and painful dressings. The usual treatment involves antibiotic topical dressings while waiting to determine the depth of the burn, followed by surgery for deeper burns. Assessing burn depth is difficult, and surgical removal of damaged tissue may remove some healthy tissue. New methods like hydro-dissection devices and enzymatic treatments like Bromolein have been explored but lack clear proof of benefit and may sometimes cause harm. This research compares PluroGel®, a special gel that helps soften and remove dead tissue while keeping the wound moist, to the standard antibiotic ointment and gauze dressings. PluroGel® is applied in a 0.5 cm layer with moist gauze twice daily, alongside the standard dressing applied three times a week. The study will assess if PluroGel® improves wound healing and reduces the need for surgery. Participants will receive either the standard dressing or PluroGel® treatment and will be followed for up to 14 days. Researchers will monitor wound healing, pain levels, satisfaction of patients and caregivers, and whether surgery is needed. The study uses a randomized, double-blind design and aims to provide evidence on the effectiveness of PluroGel® in burn care.

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.

Researchers are studying people who use intravenous drugs (PWIDs) to understand how often needle fragments remain in the body after injecting drugs and what factors contribute to this condition. Retained needle fragments can cause local pain, infections, or serious complications like needle emboli to the heart or lungs. The study aims to be the first large investigation into the frequency and risks of needle fragment retention among PWIDs, focusing on those receiving outpatient care at drug abuse service units. Participants will complete a questionnaire covering their drug use history, injection sites, and any related local symptoms. They will then undergo targeted low-dose X-ray imaging of common injection areas to detect retained needle fragments. Female participants under 50 will have a pregnancy test before imaging. The study includes an initial pilot with 20 participants to refine procedures, followed by recruitment of up to 100 total participants. During the study, researchers will collect information through questionnaires and X-ray imaging to identify needle fragment retention and related risk factors. They will also track how many participants have fragments surgically removed within five years after detection. The study involves outpatient volunteers who are currently in treatment and will last up to five years for follow-up of surgical outcomes and mortality risks associated with retained fragments.

The trial investigates the use of EscharEx, a proteolytic enzyme gel, compared to a placebo gel in treating venous leg ulcers (VLU) in adults. The goal is to evaluate how well EscharEx works and how safe it is for removing dead tissue (debridement) and preparing the wound bed for healing. This study involves adult patients who have VLUs with specific size and duration criteria. Participants will be randomly assigned to receive either EscharEx (EX-03 5% formulation) or a placebo gel. The treatment involves applying a gel made by mixing a sterile powder with water to the wound area. The study lasts up to 29 weeks and includes several phases: a screening period, up to 8 daily visits for debridement within 2 weeks, weekly wound management visits for up to 12 weeks including wound closure confirmation, and monthly visits over 12 weeks to monitor wound closure durability. During the study, patients will undergo regular clinical assessments of the wound, including visual checks for complete debridement and wound closure, as well as evaluations of healthy tissue growth. The study measures the time taken for complete wound closure and the presence of healthy tissue. Safety and wound healing progress are closely monitored throughout the treatment and follow-up periods, ensuring adherence to the protocol and proper wound management.

This research aims to evaluate the long-term safety of ALLO-ASC-DFU treatment in people who previously participated in a phase 3 clinical trial for Diabetic Foot Ulcer. ALLO-ASC-DFU is a hydrogel sheet containing stem cells from donated fat tissue that may help reduce inflammation and support wound healing. The study focuses on safety outcomes over a 24-month follow-up period. Participants in this open-label follow-up were previously treated with either the ALLO-ASC-DFU sheet or a Vehicle sheet during the earlier phase 3 trial. There is no new treatment given in this follow-up. The study observes the participants who received these treatments to monitor for any safety concerns over two years. During the study, researchers will monitor participants for abnormal lab test results up to 9 months, changes in physical exams and vital signs up to 18 months, and any local reactions at the treatment area up to 24 months. They will also track any adverse events throughout the 24 months. Participants will be involved in regular assessments to evaluate these safety outcomes under medical supervision.

Researchers are evaluating the use of a single-layer amniotic membrane called XPURT combined with standard care compared to standard care alone in treating nonhealing pressure ulcers. This multicenter, prospective clinical trial aims to better understand how this treatment approach may help wounds that have not healed over time, involving up to 100 participants from multiple providers. Participants receive weekly treatments, either standard care alone or standard care plus XPURT, for up to 20 weeks or until their ulcer fully closes. The standard care includes cleaning, debridement, moisture balance, off-loading, and reduction of bacterial burden. Weekly evaluations of the ulcers are conducted to monitor progress, and dressing changes happen once or twice a week depending on the study arm. During the study, participants attend weekly visits for wound assessment and treatment. Researchers measure wound closure, healing time, wound area reduction, pain levels, quality of life, adverse events, and product usage. The study continues until the ulcer closes or 20 weeks have passed, with confirmation of closure two weeks after it is first observed. Safety and healing progress are closely monitored throughout the trial.