A Clinical Investigation Comparing the Clinical Performance and Cost Effectiveness of Biatain® Silicone...
Venous Leg UlcerDiabetic Foot UlcerA randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study) This study (BISIL) will compare the Biatain® Silicone dressing to commonly used wound care products (AQUACEL®EXTRATM Hydrofiber® Dressing used with Mepilex® Border). The study will recruit in total 100 adult subjects with a venous leg ulcer or a diabetic foot ulcer no deeper than 2cm. Only ulcers with a duration of at least 8 weeks but no longer than a year will be included. The study will be a randomised controlled trial where half of the participants will use Biatain® Silicone and half will use the comparator for 4 weeks. Each participant will be in the study for 4-5 weeks during which there will be a weekly visit with the study team to complete the study assessments and change the dressing. The study will run for approximately one year, starting in January 2023.
Phase 2a To Evaluate PL-8177 in Subjects With Active Ulcerative Colitis (UC)
Ulcerative ColitisUlcerative Colitis Acute2 moreThe purpose of this study is to compare PL8177 (a melanocortin receptor agonist) to placebo (in a 3:1 ratio-meaning that for every 3 people that get the active drug, one will receive placebo). The study treatment will be for 8 weeks. The study will measure safety and the body's ability to handle PL8177 and look at the improvement and healing of the intestine after 8 weeks of treatment. The study will include adult males and nonpregnant, nonlactating females with acute Ulcerative Colitis (UC).
A Study of Vedolizumab in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease...
Ulcerative ColitisCrohn's DiseaseThe purpose of this study is to determine the long-term safety of vedolizumab intravenous (IV) treatment in pediatric participants with UC or CD.
LFMT vs Placebo in New Biologic Start for Ulcerative Colitis
Ulcerative ColitisTo compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.
Cell Therapy for Diabetic Foot Ulcer
Diabetic Foot Ulcer Associated With Type II Diabetes MellitusWound HealDiabetes is a highly prevalent chronic disease that affects a large part of the world's population. Among the most costly complications is the diabetic foot ulcer, where its decompensation can result in limb amputation, a risk 10 to 20 times more frequent for diabetic population. Two underlying pathophysiological mechanisms are mainly identified: neuropathy and problems associated with vasculature and blood supply, in addition to the incidence of infections, which further impairs prognosis. Skin regeneration involves several overlapping and consecutive stages, which in the case of a diabetic patient are altered. Although healing protocols have been significantly improved at the country level, and there is also a large amount of medical supplies for treatment of these wounds, there are still patients with ulcers refractory to this care that end in amputation. In response to this, new treatments have emerged that use biomaterials and cells of the patient himself, which attempt to emulate the architecture and functionality of normal tissue. Cell therapy has gained strength in recent years, with more and more studies indicating the positive effect of cell application on healing of chronic wounds with underlying pathologies, such as diabetes. The product to be evaluated corresponds to a combined medical device, which conveys a cellular therapy, known as InbioDerm+C. The purpose of this Phase II clinical study is to determine whether InbioDerm+C treatment plus advanced healing is equal to or superior to advanced healing in a diabetic population with Wagner II grade foot ulcer treated in Villa Alemana primary care family centers, Las Américas, Juan Bautista Bravo Vega and Eduardo Frei.
Pharmacokinetics of Cobitolimod Enemas in Participants With Active Ulcerative Colitis
Ulcerative ColitisThe purpose of the study is to evaluate the PK, safety and tolerability of cobitolimod ememas (500mg/50mL) given to participants with active left-sided UC.
Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis
Systemic SclerosisDigital UlcerThe MANUS Trial aims to examine the safety, feasibility and potential efficacy of intramuscularly injected allogeneic mesenchymal stromal cells as treatment for digital ulcers of systemic sclerosis.
Efficacy of Proton Pump Inhibitors in Gastrointestinal Erosions and/or Ulcers
Gastrointestinal Erosions and/or UlcersThe aim of this study is to collect the data of clinical efficacy and safety after the usage of bonoprazon and esomeprazole when the patients take NSAIDs more than 2 weeks and have gastrointestinal symptoms who have had gastrointestinal erosions and/or ulcers in the past.
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative...
Ulcerative ColitisThe purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.
Efficacy and Safety of Modified Gegen Qinlian Decoction for Ulcerative Colitis With Damp-heat Syndrome...
Ulcerative ColitisUlcerative colitis(UC) seriously affect the quality of life in patients. Clinically, it is effective to apply therapeutic method of clearing heat and promoting diuresis to the common syndrome of dampness-heat. Dysbiosis of intestinal microbiota is closely related to the immune imbalance and intestinal mucosal barrier injury. C1orf106/CYTH-1/ARF6 signal pathway, which derive from intestinal micro environment changes,is the mainly cause of intestinal mucosal barrier injury, and this is may be the common pathogenesis of dampness-heat syndrome in UC . Based on the clinic, the project is to study the effect and mechanism of Chinese compound formula of clearing heat and promoting dieresis in modulating intestinal microbiota dysbiosis, repairing intestinal mucosal barrier and reconstructing intestinal microenvironment. With the combination of metagenomics and metabonomics, the study compare the differences of co-metabolites of intestinal microbiota and host within the healthy people, UC patients with dampness-heat syndrome, to explore the relevance between intestinal flora and host co-metabolites. Furthermore, the experimental study is to clarify the drug targets via C1orf106/ CYTH-1/ARF6 signal pathway.Through the study of association between dampness-heat syndrome in UC and intestinal microbiota, it is of important academic significance to reveal the Chinese theory intension of "homotherapy for heteropathy ".