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Ulcer clinical trials

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NCT ID: NCT03747068 Completed - Ulcerative Colitis Clinical Trials

The Influence of Biologcal Treatment on the Short-Term Complications of Surgery in Patients With Inflematory Bowel Disease.

Start date: October 9, 2009
Phase:
Study type: Observational

BACKGROUND: Previous studies of short-term surgical outcomes after preoperative exposure to anti-TNF therapy in ulcerative colitis (UC) patients who have undergone IPAA have been conflicting. We sought to determine whether preoperative exposure to anti-TNF therapy affects histological measures of fibrosis in the colorectum, which may be a potential factor in adverse anastomosis complications following IPAA surgery. METHODS: Individuals who received infliximab as maintenance therapy and who received their last dose within 180 days of the first stage of IPAA were selected. The control group comprised UC patients who were not exposed to anti-TNF therapy, matched by age, sex, BMI, disease duration, albumin levels, and post-operative leak outcome. Hematoxylin and eosin- (H&E) and trichrome-stained slides from the most distal, well-oriented, full-thickness section of colorectum from each patient's total colectomy specimen were evaluated. Blinded assessment of the degree of fibrosis in the lamina propria, the submucosa, the submucosa immediately adjacent to the muscularis propria, and the subserosa was performed by a single observer using a semi-quantitative pictorial scale.

NCT ID: NCT03725787 Completed - Pressure Ulcer Clinical Trials

Pressure Ulcer Incidence Cat. II+ on a Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk

Start date: March 4, 2018
Phase: N/A
Study type: Interventional

Pressure Ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the Healthcare system, affecting approximately 1 in 20 community patients. International guidelines recommend the use of pressure redistribution support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers. It has been acknowledged that a significant proportion of pressure ulcers are avoidable. The prevalence of pressure ulcers is 1 of the 4 common harms recorded in the UK NHS Safety Thermometer, a local improvement tool for measuring, monitoring and analyzing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis. Static or reactive overlay mattresses are an example of a low-tech constant low-pressure support. Static air mattresses maintain a continuous low air pressure that exerts a pressure redistributing effect. Serraes and Beeckman found a pressure ulcer incidence of 5.1% in patients placed on static air support (mattress overlay, heel wedge and seat cushion) in a high risk population in a nursing home setting in Belgium. The CuroCell SAM PRO (Care of Sweden AB) is a static air mattress overlay system used as prevent and treat pressure ulcers (up to category 3) and for pain therapy. The aim of current study is to measure pressure ulcer incidence on the CuroCell Sam PRO static air mattress in nursing home residents at risk for pressure ulcer development over a 30-day period in Belgium.

NCT ID: NCT03725111 Completed - Leg Ulcer Clinical Trials

Haemodynamics Variations of Transcutaneous Oxygen in Patient With Areterio-venous Leg Ulcers Under Venous Compression

Start date: December 30, 2018
Phase: N/A
Study type: Interventional

Arterio-venous leg ulcers are real problems when it comes to public health because it has a major cost and leads to social and professional handicap. The management of leg ulcers is not clear and can be venous compression or surgery. The aim of the study is to evaluate the variation of the transcutaneous oxygen with compression. The second aim is to see how tolerate is the compression and the quality of life.

NCT ID: NCT03720002 Completed - Ulcerative Colitis Clinical Trials

HF2 Therapy in the Treatment of Active Ulcerative Colitis

Start date: May 29, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I-II study with the herbal formulation (HF2) for treatment of active ulcerative colitis This will be a two-stage study: Stage 1 will comprise an open label single arm exploratory study of 10 active ulcerative colitis (UC) patients investigating oral HF2 therapy for induction of remission in outpatients with active UC. Active disease is defined as (SCCAI) score ≥5 and a score of ≥2 in the modified Mayo endoscopic sub-score. Clinical remission is defined as a SCCAI score of ≤2 The patients will receive HF2 therapy for 4 weeks. Stage 2: If clinical response (defined as a drop of ≥3 points of the SCCAI score ) is achieved in ≥ 3 patients and no significant safety signals will emerge, the investigators will proceed to a prospective pilot randomized placebo-controlled study. Patients will be randomized into one of two arms: HF2 once daily or placebo formulation (2:1 proportion) for 8 weeks. The primary outcome for stage 2 is a co-primary outcome of clinical response (reduction in SCCAI of ≤3 OR achievement of clinical remission defined as SCCAI ≤2) coupled with an objective evidence of response (Mayo score improvement of ≥1 or 50% FcAL reduction) at week 8. Patients clinically responding at week 8, will be eligible to continue in an 8-weeks extension study to receive either placebo or 1.5gr/day curcumin alone until week 16, as per their original allocation. Exploratory analysis of outcomes for the extension study will include the percentage of patients in clinical remission (SCCAI≤2) and the percentage of patients who maintained clinical response (reduction in SCCAI of ≥3 point compared to week 0).

NCT ID: NCT03717233 Completed - Diabetic Foot Ulcer Clinical Trials

Assistive ExoSkeletons to Enable Wearable Rehabilitation Robotics

Start date: October 18, 2018
Phase: N/A
Study type: Interventional

Study will evaluate the use of lower-limb assistive exo-skeletons worn on the ankle and foot. Participants will wear the exo-skeletons and walk in a safe environment. Measurements will be taken to determine how the exo-skeletons affect the pressure on the feet of people with diabetic foot ulcer and how they walk.

NCT ID: NCT03716141 Completed - Diabetic Foot Ulcer Clinical Trials

Autologous Platelets Rich Plasma (APRP) Treatment Vs Saline Dressing for the Management of Diabetic Foot Ulcer

APRP
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to compare between the platelet rich plasma and normal saline dressing in the healing diabetic foot ulcers. It will be a randomized controlled trial.

NCT ID: NCT03711006 Completed - Ulcerative Colitis Clinical Trials

The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis

Start date: February 1, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days.

NCT ID: NCT03710486 Completed - Crohn Disease Clinical Trials

A Study to Observe Vedolizumab and Anti-tumour Necrosis Factors (Anti-TNFs) Outcomes in Real-world Biologic Ulcerative Colitis (UC) and Crohn's Disease (CD) Participants

EVOLVE-IBERIA
Start date: February 19, 2019
Phase:
Study type: Observational

The purpose of this study is to describe treatment patterns associated with first-line and second line biologic use (vedolizumab or other biologic) and to describe the real-world clinical effectiveness of the use (first-line and second line) vedolizumab versus other biologics at least 6 months post-treatment initiation.

NCT ID: NCT03705117 Completed - Ulcerative Colitis Clinical Trials

Open-label V565 Target Engagement Study

Start date: May 23, 2017
Phase: Phase 1
Study type: Interventional

The purpose of the study is to confirm that V565 enters inflamed tissue, binds to TNF and reduces inflammation after oral dosing to patients with IBD.

NCT ID: NCT03700580 Completed - Diabetic Foot Clinical Trials

Clinical Trial Using the Proteolytic Fraction P1G10 From V. Cundinamarcensis to Heal Diabetic Foot Ulcer

P1G10
Start date: August 15, 2012
Phase: Phase 2
Study type: Interventional

The aim of the study was to investigate the role of the proteolytic fraction from Vasconcellea cundinamarcensis, designated as P1G10, on healing of chronic foot ulcers in neuropathic patients diagnosed with diabetes type 2. Fifty patients were enrolled in a prospective, randomized, double-blind trial, to verify the efficacy and safety of a topical dressing containing 0.1% P1G10, versus a Hydrogel (positive control) protocol currently applied at the Health Center to treat this condition. Upon completion of the intervention, the outcome evaluated the number of patients attaining full epithelization (100%), or at least 80% healing in both arms (P1G10 versus Hydrogel). Statistical analysis compared the endpoint data on each group to assess the significance of differences.