Circleville

Researchers are evaluating the safety and effectiveness of EscharEx (EX-03 5% formulation), a gel made from a sterile lyophilized powder containing proteolytic enzymes, compared to a placebo gel without enzymes. The study focuses on the treatment of Venous Leg Ulcers (VLU), which are wounds on the legs caused by poor venous blood flow. This Phase 3 trial will involve at least 216 adults with VLUs that range in size from 2 to 25 square centimeters and have lasted between 4 weeks and 12 months. Participants will be randomly assigned to receive either EscharEx or the placebo in a double-blinded setup, meaning neither patients nor researchers know which treatment is given. The study lasts up to 29 weeks and includes several stages: a screening period with two visits one week apart; a daily treatment phase with up to eight daily applications over two weeks to remove necrotic tissue; a weekly wound management period lasting up to 12 weeks with up to 13 visits, plus up to two weeks for confirming wound closure; and finally, a 12-week monthly follow-up with three visits to monitor wound closure durability. Throughout the study, researchers will visually assess the removal of dead tissue after each treatment application and monitor the time it takes for the wound to fully close. Patients will undergo standardized wound care and regular clinical evaluations, including measurements of the wound area. Safety and wound healing progress will be carefully tracked during all visits, ensuring comprehensive monitoring of treatment effects and wound status over the entire study duration.

Researchers are evaluating different types of cellular, acellular, and matrix-like products (CAMPs) combined with standard care compared to standard care alone for healing nonhealing diabetic foot ulcers and venous leg ulcers. This multicenter, prospective, randomized controlled trial uses a modified multi-platform (Matriarch) design to compare these treatments and determine differences in ulcer closure over 12 weeks. The study aims to include multiple CAMPs per wound type and allows for adding more during the trial. Participants will receive weekly treatments starting at screening. One group will get standard care for diabetic foot ulcers or venous leg ulcers, including cleaning, debridement, moisture balance, offloading for foot ulcers, or compression for leg ulcers, until the ulcer closes or for up to 13 weeks. Other groups will receive weekly applications of various CAMP products plus standard care following the same schedule. The trial tests several products such as AmnioCore, Amnio Quad-Core, Amnio Tri-Core, AmnioCore Pro, and AmnioCore Pro +. During the study, participants will attend weekly visits for treatments and monitoring. Researchers will assess wound healing progress, measuring ulcer size to determine closure rates up to 12 weeks. The trial monitors safety and effectiveness by comparing the proportion of ulcers completely closed between treatment groups. Participants must commit to weekly visits and adhering to prescribed offloading methods. The total treatment period lasts up to 13 weeks with ongoing evaluation of healing outcomes.

Researchers are evaluating the safety and effectiveness of MTX-001 in patients with non-infected venous stasis ulcers (VSU) that have not improved after at least 4 weeks of standard wound care. This Phase 2, randomized, double-blind, placebo-controlled study includes patients who have wounds caused by venous reflux disease and meet specific wound size and age criteria. The goal is to assess whether MTX-001 can help this difficult-to-heal type of ulcer. The study is conducted in two parts. In Part 1, 11 patients received MTX-001 either once weekly or once every two weeks alongside standard care. In Part 2, about 70 patients are randomized to receive either MTX-001 or a placebo injection weekly with standard care over 12 weeks. The treatment involves localized subcutaneous injections into and around the wound during weekly clinic visits. Participants will be assessed at screening, baseline, and weeks 4, 8, and 12. Researchers will measure wound surface area reduction, wound healing progress, and total wound closure by week 12. Safety and tolerability are monitored throughout the 12-week treatment period. Patients' pain levels and other health assessments will also be collected to evaluate preliminary treatment effects.

Researchers are evaluating the safety and effectiveness of different types of placental-based allografts—Amnion/Chorion/Amnion, Amnion/Chorion, and Amnion/Amnion—combined with standard care compared to standard care alone for treating chronic non-healing diabetic foot ulcers (DFUs). The study focuses on adult patients with Wagner Grade 1 DFUs that have persisted for more than 4 weeks but less than 1 year. The goal is to observe healing outcomes over a 12-week treatment period. Participants will receive one of the allograft treatments plus standard care or standard care alone. The ulcers treated will range from 1.0 cm² to 25 cm² in size, and the affected foot must show adequate circulation confirmed by various vascular tests. The ulcers must have been offloaded for at least 14 days before treatment begins. Treatments involve applying the allografts to the ulcer sites and following the care protocols throughout the study. During the study, participants will attend weekly visits for assessments, including monitoring the healing progress of the diabetic foot ulcers. Measurements will be taken to determine the percentage of ulcers healed at 12 weeks. Safety and adherence will be tracked, and participants must be able to comply with the scheduled visits. The study also includes pregnancy testing for females of childbearing potential and requires participants to sign informed consent before starting.