Circleville

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.

The trial investigates the treatment of nonhealing diabetic foot ulcers DFU and venous leg ulcers VLU by comparing several cellular, acellular, and matrix-like products CAMPs combined with standard of care SOC against SOC alone. It aims to determine the difference in the proportion of patients achieving complete closure of these ulcers over 12 weeks using a modified dual platform design called Matriarch. The study may evaluate up to five CAMPs per wound type, with flexibility to include more as needed. Participants receive weekly treatments either with SOC alone or SOC plus one of several CAMPs. SOC includes cleaning, debridement, moisture balance, and offloading for DFUs, or compression for VLUs. CAMPs tested include various types of amniotic membrane allografts applied weekly alongside SOC, continuing until ulcer closure or a maximum of 13 weeks. The study has multiple arms representing different CAMP products and SOC for both DFUs and VLUs. Throughout the study, participants attend weekly visits where ulcer healing progress is assessed, including measurements of closure, time to closure, and area reduction. Pain levels and quality of life improvements are monitored alongside safety through adverse event tracking up to 14 weeks. The trial involves regular assessments to evaluate the effectiveness of treatments and patient well-being during the treatment period and follow-up.

Researchers are evaluating the safety and effectiveness of MTX-001, a treatment for non-infected venous stasis ulcers VSUs that have not improved after at least four weeks of standard wound care. This randomized, double-blind, placebo-controlled Phase 2 study involves patients who have chronic wounds and aims to compare MTX-001 to a placebo when given alongside usual wound therapy. The study is conducted at multiple centers and includes a lead-in phase to determine dosing frequency, followed by a randomized treatment phase. Participants receive subcutaneous injections of either MTX-001, which is human amniotic fluid, or a placebo solution injected into and around the wound once weekly during clinic visits for 12 weeks. The trial includes a lead-in phase where dosing frequency was assessed and a main phase where approximately 70 patients are randomized 11 to receive either MTX-001 or placebo along with standard care. Treatment is given weekly as needed over the 12-week period. Throughout the study, participants are assessed at screening, baseline, and weeks 4, 8, and 12 for safety and wound healing progress. Measurements include wound surface area reduction, total wound closure, pain changes, quality of life, and global impression of change. Researchers track healing by comparing wound size from baseline to follow-up visits. The study monitors safety and tolerability from baseline to week 12. Participation covers the entire 12-week treatment and observation period.

Researchers are evaluating the safety and effectiveness of three types of placental tissue allograftsAmnionChorionAmnion, AmnionChorion, and AmnionAmnionalongside standard wound care compared to standard care alone for treating chronic non-healing diabetic foot ulcers DFUs. The study focuses on adults with chronic DFUs to understand whether adding these allografts improves healing after 12 weeks of treatment. Participants will receive one of several treatments topical application of a tri-layer dehydrated amniotic membrane allograft, a tri-layer amnionchorion allograft, a dual-layer amnionamniotic membrane allograft, or standard wound care alone. Standard care includes calcium alginate dressings, padded multi-layer dressings, offloading boots or total contact casting, debridement, and infection management. The allografts provide a protective cover and support the bodys natural healing processes and are applied directly to the ulcer without removal. During the study, participants will attend weekly visits for up to 12 weeks. Researchers will assess wound healing by measuring the percentage of ulcers healed, total time to wound closure, reduction in wound size over time, and changes in patients reported wound pain. The study includes careful monitoring of ulcer condition and overall health to evaluate treatment safety and effectiveness over the treatment period.