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Ulcer clinical trials

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NCT ID: NCT02352467 Recruiting - Pressure Ulcer Clinical Trials

Effectiveness of Aurix Therapy in Pressure Ulcers

Start date: February 2015
Phase: N/A
Study type: Interventional

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix and standard care and compared 1:1 to patients receiving undefined Usual and Customary Care.

NCT ID: NCT02352454 Recruiting - Venous Leg Ulcers Clinical Trials

Effectiveness of Aurix Therapy in Venous Leg Ulcers

Start date: February 2015
Phase: N/A
Study type: Interventional

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which venous leg ulcers (VLU)n will be treated using Aurix and compared to patients receiving undefined Usual and Customary Care (UCC)

NCT ID: NCT02322554 Recruiting - Pressure Ulcer Clinical Trials

Cellular and Tissue Based Therapy Registry

CTPR
Start date: January 2005
Phase:
Study type: Observational [Patient Registry]

The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide real world patient data from electronic health records submitted to meet Stage 2 Meaningful Use in order to understand the value of these products among patients with chronic wounds and ulcers. Randomized, controlled trials to establish product efficacy routinely exclude patients with the co-morbid conditions common to patients seen in usual clinical practice and thus the results of these RCTs tend to be non-generalizable. Little is known about the effectiveness of CTPs among typical patients.

NCT ID: NCT02312596 Recruiting - Clinical trials for Diabetic Foot Ulcers

A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Non-Healing Diabetic Foot Ulcers

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

A prospective, randomized, controlled, clinical study to establish clinical based evidence of PRP Concepts Fibrin Bio-Matrix and compare its performance with the usual and customary practice for the treatment of Wagner 1 or 2 DFUs.

NCT ID: NCT02312570 Recruiting - Pressure Ulcer Clinical Trials

A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Pressure Ulcers

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

To assess the efficacy of the PRP Concepts Fibrin Bio-Matrix and compare its performance with usual and customary practice for the treatment of chronic non-healing pressure ulcers (PU).

NCT ID: NCT02312518 Recruiting - Venous Leg Ulcers Clinical Trials

A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Venous Leg Ulcers

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

To assess the efficacy of the PRP Concepts Fibrin Bio-Matrix and compare its performance with usual and customary practice for the treatment of chronic non-healing venous leg ulcers (VLU).

NCT ID: NCT02304666 Recruiting - Clinical trials for Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)

Study of Inflammatory Markers (VNN1) in Crohn Disease and Ulcerative Colitis.

VANIN
Start date: November 2014
Phase: N/A
Study type: Interventional

Inflammatory Bowel diseases (IBD) include Crohn's disease and ulcerative colitis. IBD's precise origin is unknown until now. Today, the current hypothesis of the disease pathogenesis is that IBD result from a dysregulated mucosal immune response to the gut microbial flora in genetically susceptible hosts. The intestinal homeostasis depends on interactions between immune and epithelial cells. Epithelial cells are the first line of defense, are tightly connected to the underlying gut associated lymphoid tissue and their alteration results in loss of tissue homeostasis. Vanin-1 (Vnn1 in mice, VNN1 in humans) is an epithelial pantheinase which regulates the cell response to stress. This ectoenzyme hydrolyses the vitamin B5-derivative pantetheine to provide cysteamine to tissues and regenerate pantothenate. Previous studies have shown that Vnn1 KO mice were more resistant to experimental colitis and administration of cystamine (oxidized form of cysteamine) restored their susceptibility to colitis. Furthermore, analysis of VNN1 expression in IBD patients show that high VNN1 expression is associated with severe clinical features. Thus, analysis of VNN1 expression could represent a good prognostic marker. In a recent published article, we characterized among a retrospective cohort of 500 IBD patients and controls new SNPs (single nucleotide polymorphisms) in the VNN1 promoter and showed their association with IBD incidence and high VNN1 expression. This suggested that the VNN1gene might be a new predisposition marker of IBD. In mouse, Vnn1 expression is tightly regulated by activation of PPARa and PPARg transcription factors. Interestingly, one of the SNPs identified in patients participates to a PPARg binding site. Interestingly, drugs related to the family of 5-ASA which are commonly used in IBD, have PPARgamma agonist potential. Therefore, quantifying VNN1 levels in patients under 5-ASA therapy might help predicting response to therapy and select patients with the highest benefit for this therapy. The purpose of this new project is to extend our initial analysis. The study will be prospective, monocentric and controlled. Its primary objective is to evaluate the level of VNN1 expression in the colonic mucosa between IBD patients and control subjects to confirm the correlation between high VNN1 expression and IBD. In relation with its prospective nature, we will also try to associate VNN1 expression level with specific endophenotypes (severity and/or localization of the lesions, quality of the response to therapy). Finally, we will screen patients for the previously identified SNPs to integrate this information in the interpretation of the results of expression analysis. This study is planned on 2 years. Two groups of patients will be constituted: one group will include IBD patients followed in the " Service de Gastro-entérologie du Pr Grimaud à l'Hôpital Nord " and the other group will constitute the control cohort including persons who were proposed a screening colonoscopy for familial history of colon cancer or polyps, or for Irritable Bowel Syndrome. The investigator will have to fill a questionnaire for each included patient, collecting information about age, sex, past medical history, taken medicine, digestive symptoms and colonoscopy indication. IBD patients will have a first set of biopsies (n = 10) and blood samples collected under general anesthesia during a colonoscopy planned in their IBD usual follow-up; a second set of similar samples will be collected within the next 12 months if an endoscopic control is medically justified. The control subjects will have only one set of biopsy and blood samples collected under general anesthesia during their colonoscopy. In the particular case of IBD patients who require surgery, a small piece of the resection will be collected ex-vivo on both healthy and pathologic areas. The blood sample will serve for quantification of the VNN1 seric pantheteinase activity and SNP's genetic study. The colonic biopsies will be obtained in duplicates from 5 different ileocolonic areas, one for histopathological analysis and the other for transcriptional analysis by qRT-PCR. The surgical samples will be used for transcriptional activity, tissue pantheteinase activity and constitution of TMA (Tissue MicroArrays) bank for immunohistochemistry. Expected benefits are to validate a new IBD prognostic marker for disease severity or potentially for evaluation of the therapeutic response.

NCT ID: NCT02296697 Recruiting - Pressure Ulcer Clinical Trials

Low-level Laser Therapy Versus High Frequency on Pressure Ulcers Treatment

Start date: January 2015
Phase: N/A
Study type: Interventional

Patients admitted in the Emergency Service that have pressure ulcers will be selected by eligibility criteria and randomized into three groups according to the adopted therapy: wound dressing (CG); wound dressing + high-frequency generator group (GAF); and wound dressing + low-level laser therapy group (GLBP).

NCT ID: NCT02286427 Recruiting - Ulcer Clinical Trials

A Comparative Study of the Healing of Chronic Ulcers of Recessive Epidermolysis Bullosa : Dressing vs Amniotic Membrane

MABUL
Start date: January 2015
Phase: Phase 3
Study type: Interventional

Skin wounds of Recessive Epidermolysis Bullosa Dystrophica (REBD) involve pain, superinfection, protein-losing, inflammation, and joint contractures are the bed of squamous cell carcinoma. There is no precise data on the kinetics of healing post-bullous erosions but clinical experience suggests that most epidermise in less than a month. Some, however, for unknown reasons, persist for several months. These chronic ulcers (UC), arbitrarily defined for this study as lasting more than three months are a source of major discomfort and could play a decisive role in the morbidity and mortality of the disease. The aim of this study is to evaluate the efficacy of the amniotic membrane on the healing of chronic ulcers REBD on the percentage ulcerated surface re-epithelialised at 12 weeks (M3) from the start of treatment.

NCT ID: NCT02280733 Recruiting - Clinical trials for Peripheral Arterial Disease

A Real World, Observational Registry of Chronic Wounds and Ulcers

USWR
Start date: January 2005
Phase:
Study type: Observational [Patient Registry]

More than 100 hospital based outpatient wound centers in the USA and Puerto Rico agree to transmit structured data on all patients followed with chronic wounds and ulcers (e.g. diabetic foot ulcers, venous ulcers, pressure ulcers, arterial ulcers, surgical wounds, and traumatic wounds). Data are collected at point of care including adherence to wound care quality measures developed by the USWR as a Qualified Clinical Data Registry (QCDR).