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Ulcer clinical trials

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NCT ID: NCT03818828 Completed - Venous Leg Ulcer Clinical Trials

Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01)

Start date: February 14, 2019
Phase: Phase 2
Study type: Interventional

It is hypothesized that application at 4-week intervals of the human umbilical cord tissue TTAX01 to the surface of a well debrided, nonhealing venous leg ulcer (VLU) will result in a high proportion of wounds showing complete healing within 12 weeks of initiating therapy. This open label pilot study provides a framework for a larger, controlled study. The purposes for conducting this study are to evaluate the functionality of the protocol and to obtain an estimate of product safety and efficacy when applied according to the protocol instructions, and measured according to the stated endpoints.

NCT ID: NCT03813927 Completed - Clinical trials for Vitamin D Deficiency

Vitamin D Treatment of Diabetic Patients With Foot Ulcers

Start date: April 1, 2016
Phase: N/A
Study type: Interventional

The purpose of this study, is to determine whether daily supplements of vitamin D improves wound healing in diabetic patients with chronic foot ulcers.

NCT ID: NCT03795064 Completed - Venous Ulcer Clinical Trials

Immediate Versus Early Endovenous Ablation In Venous Ulcer

Start date: December 5, 2018
Phase: N/A
Study type: Interventional

The study is conducted to assess the effects of immediately started foam sclerotherapy in venous ulcer compared to early intervention.

NCT ID: NCT03794765 Completed - Ulcerative Colitis Clinical Trials

Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis

AAASUC
Start date: April 1, 2019
Phase: Phase 2
Study type: Interventional

The study is planned as a randomised control trial to study the adjuvant use of antibiotics (ceftriaxone and metronidazole) to achieve a clinical response in hospitalised patients with acute severe ulcerative colitis

NCT ID: NCT03788642 Completed - Diabetic Foot Ulcer Clinical Trials

Low-level Laser Therapy for the Treatment of Diabetic Foot Ulcer

Start date: January 15, 2019
Phase: N/A
Study type: Interventional

The study evaluates the efficacy of Low-level laser therapy on ulcer healing in patients with diabetic foot ulcer. Half the patients are randomized to receive Low-level laser therapy and a half to recieve the placebo (LED).

NCT ID: NCT03782727 Completed - Skin Cancer Clinical Trials

ObservAtional Study to Investigate Surgical Site Infection in Ulcerated Skin Cancers

OASIS
Start date: March 12, 2019
Phase:
Study type: Observational

The investigators aim to recruit 311 participants to this study from three UK Dermatology departments. The investigators will invite people with suspected skin cancers whose lesions have a broken surface (also known as ulcerated) who will undergo surgery. This study is being carried out because it is possible that patients with skin cancers with ulceration might be at greater risk of developing a wound infection after surgery. The aim of this study is to determine how many people with ulcerated skin cancers develop an infection of the wound after it has been surgically removed. People with ulcerated skin cancers who will have surgery will be invited to participate in the study. If they agree, a member of the research team will explain the study and consent them to participate in the study. At the time of surgery, information will be collected about the participant, skin tumour and procedure. The participant will be given standardised advice regarding wound care and further care will be as per each centre's 'normal clinical care'. If participants are diagnosed with a wound infection then they will asked to take a 'wound selfie' and share the photo with the research team. The research team will contact the participant via a postal questionnaire which will be sent four weeks after the procedure to determine whether they had any concerns about post-operative infection and whether any action was taken. Additionally, all participants at the University Hospital of Wales will have a surface swab taken from their ulcerated skin cancer and these will be analysed in the Public Health Wales laboratory at the University of Wales, Cardiff. The aim of this aspect of the study is to identify the most common bacteria in ulcerated tumours.

NCT ID: NCT03781284 Completed - Ulcerative Colitis Clinical Trials

PET Combined With MRI for Monitoring Inflammatory Activity in Patients With Ulcerative Colitis

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

Colonoscopy is considered crucial for the diagnosis and quantification of ulcerative colitis (UC). However, there are several drawbacks related to the invasiveness, procedure-related discomfort, risk of bowel perforation (especially in the period of acute inflammation), and relatively poor patient acceptance. Most patients regard the necessary bowel cleansing as burdensome. Feasible, accurate and well accepted non-invasive diagnostic techniques are needed for the determination of inflammatory activity and optimal tailoring of therapy. Hybrid PET/MRI represents an innovative combination of two established, non-invasive diagnostic tools: Magnetic resonance imaging (MRI), allowing for anatomic-functional imaging of the abdomen at high soft tissue contrast and positron emission tomography (PET) utilizing 18F-fluorodeoxyglucose (FDG) a non-invasive tool to monitor glucose metabolism and allowing a detection and quantification of inflammatory processes. Since MRI has limited sensitivity in UC and may be hampered by retained stool, a combination with another imaging modality is very appealing. PET, on the other side provides functional information, yet with limited anatomical landmarks and is relatively unsusceptible to artifacts associated to retained stool. In combination, these modalities might provide a valid alternative for the non-invasive assessment of the inflammatory activity in UC patients without the need for bowel purgation. It will therefore have to be investigated whether fecal material does impede the diagnostic quality of the combination of FDG-PET and MRI. For this purpose, the investigators will include 50 patients with confirmed ulcerative colitis. Dependent on clinical activity of the inflammation, patients will be randomized to undergo PET/MRI enterography either with or without prior bowel purgation followed by a colonoscopy. Inflammatory activity in 7 bowel segments will be analyzed based on PET/MRI with and without bowel purgation with the results of colonoscopy as standard of reference. Patient acceptance of PET/MRI with and without bowel purgation as well as colonoscopy will be compared. PET/MRI with and without bowel cleansing will be compared with regard to diagnostic accuracy as well as for its patients' acceptance in comparison to colonoscopy. The investigators hypothesize that PET/MRI will eventually be highly accurate to detect and monitor inflammatory activity in patients with ulcerative colitis. Additional information about extra-intestinal findings might also change the therapeutic concept. PET/MRI might serve as a non-invasive diagnostic option in patients with UC to quantify inflammatory activity especially when bowel cleansing or colonoscopy is not applicable.

NCT ID: NCT03773952 Completed - Ulcerative Colitis Clinical Trials

Safety and Efficacy of PBF-677 in Ulcerative Colitis Patients

ADENOIBD
Start date: July 1, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase IIa (proof of concept), randomized, double blind, placebo-controlled, multicentre clinical trial to evaluate the safety and efficacy of daily PBF-677 oral treatment during 28 days in Ulcerative colitis (UC) patients who are not receiving immunosuppressants and present mild-to-moderate activity of the disease. Enrolled patients would receive standard high doses of 5-ASA (4g), according to current clinical guidelines, and are randomized to receive also PBF-677 or placebo.

NCT ID: NCT03773445 Completed - Ulcerative Colitis Clinical Trials

Golimumab Trough Levels in Patients With Ulcerative Colitis

GLMLEVEL
Start date: March 1, 2019
Phase:
Study type: Observational

Proactive therapeutic drug monitoring of Anti-TNFs with drug titration to a therapeutic window is associated with favorable long-term therapeutic outcomes in IBD and may be superior to reactive therapeutic drug monitoring. Moreover, many exposure-response relationship studies have shown that higher serum anti-TNF drug concentrations are associated with better clinical outcomes in IBD, suggesting that it is maybe time to go from a 'treat-to-target' to a 'treat-to trough' therapeutic approach. In this scenario, there are very limited data regarding therapeutic drug monitoring with golimumab in UC and even no data regarding a therapeutic window to target for important objectives outcomes like mucosal healing and histological remission.

NCT ID: NCT03760003 Completed - Ulcerative Colitis Clinical Trials

Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis

Start date: September 23, 2019
Phase: Phase 2
Study type: Interventional

Phase IIb study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis.