Ulcer

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.

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.

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.

Researchers are evaluating the effectiveness of a single layer placental-based allograft combined with standard care for treating nonhealing diabetic foot ulcers. This controlled clinical trial follows a rescue design where patients who do not heal during a previous trial (CAMPX) and were treated only with standard care can enroll to receive the new study product. Participants must meet specific medical criteria related to cellular and matrix-like products as defined by Medicare guidelines. The intervention involves applying the single-layer amniotic membrane product called XWRAP alongside standard care for up to 12 weeks. Patients entering this rescue trial previously failed to heal their ulcers under standard care alone in the CAMPX trial. This study evaluates wound closure and related healing outcomes over this 12-week period. Participants will attend weekly study visits for up to 12 weeks during which researchers will assess wound closure, time to closure, wound size reduction, adverse events, and quality of life related to the wound. Several scales measuring wound impact and pain will also be used. Safety and wound healing progress will be closely monitored throughout the study duration.

Researchers are evaluating the effectiveness of human placental membrane products combined with standard care for treating nonhealing diabetic foot ulcers and venous leg ulcers. This multicenter, prospective, controlled trial follows a rescue design where patients who do not heal with standard care in a related trial may receive one of the study products. Patients must meet specific medical criteria for cellular or matrix-like products as outlined by Medicare guidelines. Participants are randomly assigned to receive one of several human amniotic membrane allograft products—Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Lite™, or Membrane Wrap-Hydro™—along with standard care. These products are applied weekly until the ulcer heals or up to a maximum of 12 weeks. The trial includes a rescue phase for those who fail to heal in the standard care arm of a previous related study. During the study, participants attend weekly visits for treatment application and monitoring. Researchers will assess wound closure percentage within 1 to 12 weeks as the primary outcome. Secondary measures include time to wound closure, area reduction, adverse events, quality of life improvements, and pain levels for those with significant pain. The total participation period may last up to 12 weeks, with regular evaluations to track healing and safety.

This research aims to evaluate the effectiveness, safety, and tolerability of DermaBind TL, a full-thickness dehydrated placental allograft, in patients with chronic non-healing ulcers, including diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). The trial focuses on patients whose wounds have not responded to standard treatments. The study is a prospective, multi-center, open-label, single-arm clinical trial led by HealthTech Wound Care, designed to collect outcome data over a 12-week treatment period. Participants will receive DermaBind TL applied to their wounds while following standard care, including offloading with devices like CAM boots or total contact casting, wound debridement, infection management, and layered dressings for protection. The treatment phase lasts 12 weeks with assessments for wound area protection, infection rates, and adverse events. The study includes a screening phase to determine eligibility before treatment begins. During the study, clinicians will assess wounds regularly to monitor wound size, infection, and healing progress. Data will be collected on the number of grafts used and any treatment-related adverse effects. Outcome measures include wound area preservation and protective effects of the dressing over 13 weeks. Participants must comply with offloading and dressing protocols and will be followed for safety and treatment tolerability throughout the study duration.

Researchers are evaluating the treatment effect of MDI-1228-mesylate Gel compared with standard care alone in people with diabetic foot ulcers. The study aims to measure the complete healing rate after 12 weeks of treatment and the proportion of patients whose ulcer size is reduced by half. This Phase 2a trial plans to enroll about sixty adults aged 18 to 75 years with specific diabetic ulcers that have lasted at least 12 weeks. Participants will be randomly assigned in a 2:1 ratio to either receive the study gel plus standard care or standard care alone. The gel will be applied twice daily for 12 weeks. Standard care includes wound cleaning, debridement, and other treatments as determined by healthcare providers. All ulcers will be treated, but only the largest ulcer will be the focus of measurement. The trial includes up to a 14-day screening period, 12 weeks of treatment, and a 4-week follow-up. During the study, participants will have their ulcers regularly monitored and photographed by designated staff to ensure consistency. Researchers will assess healing progress, time to ulcer closure, and any treatment-related side effects. Participants will attend visits at the end of treatment and at follow-up to evaluate outcomes, with the total study lasting up to 18 weeks.