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Pressure Ulcer clinical trials

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NCT ID: NCT00664235 Recruiting - Pressure Ulcers Clinical Trials

The Analysis of Skin Temperature by Long Wave Infrared Imaging to Determine Its Effectiveness as a Predictor of Tissue Injury

Start date: February 2008
Phase: N/A
Study type: Observational

Long-wave infrared imaging can be used to identify skin temperature changes associated with underlying tissue changes. We want to determine if the use of Long Wave infrared Imaging is as effective as the Braden Score in predicting nosocomial pressure ulcers.

NCT ID: NCT00628602 Completed - Pressure Ulcer Clinical Trials

BION Active Seating for Pressure Ulcer Prevention

Start date: November 2007
Phase: Phase 1
Study type: Interventional

Pressure ulcers (PUs) are a debilitating pathology resulting from pressure and shear in the soft tissues of immobilized patients. In studies to date, BION neuromuscular stimulation has been demonstrated to activate strong muscle contractions and to produce skeletal motion, with associated increases in muscle bulk (hypertrophy), strength, and metabolic capacity, hence counteracting the 3 major etiological factors in PU development (immobility, soft-tissue atrophy and hypoxia). This study intends to use neuromuscular stimulation to both shift paralyzed subjects' weight and build up gluteal muscle volume, in order to prevent recurrence of pressure ulcers. We will implant BIONs alongside the already exposed inferior gluteal and sciatic nerves in patients who are undergoing gluteal rotation flap surgery for PU reconstruction. The gluteal rotation flap is a common reconstructive technique for treating PUs by bringing healthy muscle and skin in to repair the deficient area, and to provide healthy tissue covering over bony prominences. The implanted BIONs will enable us subsequently to stimulate the gluteus maximus and hip extensor muscles. Outcome measures will include tissue health variables (measured by clinical assessment, X-Rays, MRI and Sesta-MIBI SPECT perfusion scans), pressure redistribution (measured by an array of pressure sensors), and recurrence rates over 12 months.

NCT ID: NCT00624806 Completed - Spinal Cord Injury Clinical Trials

Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D

Start date: February 2008
Phase: N/A
Study type: Interventional

The Veteran's Health Administration (VHA) is a national leader in using distance technology to monitor patients' self-care via an in-home messaging device with disease management protocols (DMPs). No such DMPs exist for the community dwelling spinal cord injury/disorders (SCI/D) population. Our objective is to develop the tools necessary for implementing a new home telehealth program to manage community-dwelling veterans with SCI/D at high risk of developing pressure ulcers (PrUs).

NCT ID: NCT00623948 Withdrawn - Pressure Ulcers Clinical Trials

Implanted Gluteal Stimulation System for Pressure Sore Prevention

Start date: September 2012
Phase: N/A
Study type: Interventional

This project will evaluate the feasibility of using a fully implanted gluteal stimulation system for the prevention of Pressure ulcers. The specific goal of this study will be a pilot clinical trial of veterans with reduced mobility in order to establish clinical efficacy of a 2-channel bilateral gluteal stimulation system. A two-arm crossover study of wheelchair users with complete SCI will be carried out. All study participants will receive a fully implanted system incorporating implanted IM electrodes and a Micropulse I IPG stimulator (NDI Medical). Group assignments will be determined at enrollment using a modified randomization scheme. A total of 10 subjects will be recruited to the pilot clinical trial.

NCT ID: NCT00535548 Recruiting - Wound Healing Clinical Trials

Hematopoietic Stem Cell Therapy in Chronic Wounds Using a Pressure Sore Model

Start date: January 2007
Phase: Phase 1
Study type: Interventional

Aim of the study: Evaluation of feasibility, safety and potential effects of stem cells on chronic wounds using a pressure sore model. Clinical relevance: - Accelerated healing of uncomplicated wounds - Enhanced healing of complicated (chronic, non-healing) wounds Study design: - Prospective controlled phase I/II study - Cohort of 5 patients in pilot study, then reevaluation Patients: - Para- and tetraplegic patients with sacral pressure sores grade III-IVA according to the classification of Daniel and Seiler Methods: 1. First surgical intervention: - Radical debridement of pressure sore - Bone marrow harvest from the iliac crest - Isolation of hematopoietic stem cells, aiming to gain > 1 mio. CD 34+ cells per patient under GMP conditions 3. Stem cell therapy (after 2 days) - Injection of stem cells in suspension (50'000 CD 34+ cells in 100 microliter saline per cm2 of wound surface) on one half of the total wound surface and cell-free saline on the other half as a control 4. Second surgical intervention (after 3-4 weeks): - Complete excision of the wound - Closure of the defect by fasciocutaneous flap 5. Evaluation of wound healing: - Clinical - 3D laser imaging - Histology - Growth factor assay

NCT ID: NCT00521027 Completed - Diabetic Foot Clinical Trials

Study Comparing VERSAJET With Conventional Surgical Procedures in the Removal of Unhealthy Tissue From Lower Limb Ulcers

Start date: April 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the VERSAJETâ„¢ device with conventional surgical procedures (performed with a scalpel) in the debridement (removal of unhealthy tissue) of lower limb ulcers. It is hypothesised that the time taken to debride lower limb ulcers will be quicker with the VERSAJETâ„¢ device than with conventional surgical procedures.

NCT ID: NCT00507650 Completed - Pressure Ulcers Clinical Trials

Increasing Fluids in Older Adults to Prevent & Treat Pressure Ulcers

Start date: September 2003
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether providing extra fluid to nursing home residents will help prevent or heal pressure ulcers. We hypothesize that providing extra fluid to nursing home residents will increase their skin blood flow and oxygen to support healing and maintaining healthy skin. Participants are enrolled who have a pressure ulcer or who are at-risk for an ulcer (determined by looking at risk factors). The study is divided into two 10 day phases. In Phase 1, we examine participant's usual status, including fluid intake and baseline healing potential. In Phase 2, participants are randomly placed in groups to receive either their usually prescribed fluid intake or additional fluid. A study nurse provides the fluid to the residents. We measure their actual intake, their body water, how well their kidneys are working, their potential to heal, and also monitor them for the development of fluid overload. This study is important because it helps us understand the role of a basic nursing intervention in the prevention and treatment of pressure ulcers.

NCT ID: NCT00504855 Terminated - Pressure Ulcer Clinical Trials

Cast Sores With Waterproof Vs. Standard Cast Padding

Start date: July 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to compare waterproof cast padding material to standard cotton/poly-cotton cast padding material to the presence or absence of cast sores of the heel.

NCT ID: NCT00502372 Terminated - Pressure Ulcers Clinical Trials

Effect of an Oral Supplement Enriched in Amino Acids and the Leucine Metabolite B-hydroxy B-methylbutyrate (HMB)

Start date: December 2008
Phase: Phase 1
Study type: Interventional

The focus of this study is to look at the role of nutrition in the healing of pressure ulcers. The purpose of this study is to test whether the rate of healing of pressure ulcers is increased in those patients receiving a nutritional supplement of amino acids and the leucine metabolite, B-hydroxy-B-methylbutyrate is enhanced when compared to control patients receiving a supplement containing only one of the proteins in the experimental supplement

NCT ID: NCT00487097 Completed - Intensive Care Clinical Trials

The Effect of Antioxidants on the Immune Response and Wound Healing in Critically Ill Patients

Start date: September 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether the addition of omega-3 and antioxidants to nutritional support in critically ill patients in the intensive care unit influences the immune and anti-inflammatory systems and so improves wound healing.