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Pressure Ulcer clinical trials

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NCT ID: NCT05144646 Not yet recruiting - Pressure Ulcer Clinical Trials

Peripheral Tissue Perfusion and Oxygenation in Areas at Risk of Press Ulcer (POTER-OIL)

POTER-OIL
Start date: January 4, 2022
Phase: N/A
Study type: Interventional

The study objectives will be: Primary objectives: 1. To determine the effects on oxygenation and tissue perfusion of applying HFA (Hyperoxygenated Fatty Acids) or EVOO (Extra Virgin Olive Oil) to the heels of healthy subjects, evaluating the maximum variation of oxygenation and flow when the heels are subjected to pressure. 2. To determine the levels of tissue oxygenation and perfusion associated with the appearance of blanching erythema in the heels of acute hospitalised patients and patients admitted to social health centers for the elderly. Secondary objectives: 1. To determine whether there are differences in oxygenation and peripheral tissue perfusion between heels to which HFA vs. EVOO is applied. 2. To evaluate the possible progressive loss of the efficacy of HFA and EVOO in terms of tissue oxygenation and perfusion in patients who are bedridden for extended periods. Methodology: Experimental study in two phases: preclinical and clinical. Phase 1 with healthy subjects, with a randomized and open design, with an intrasubject control group. Phase 2 with hospitalized subjects and patients admitted to social health centers for the elderly, with a randomized and open design, with an intrasubject control group.

NCT ID: NCT05089890 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Clinical Investigation of Sorbact® Dressings

Start date: October 2021
Phase: N/A
Study type: Interventional

The main purpose of this exploratory clinical investigation is to study the binding of bacteria and fungi from hard-to-heal wounds to the DACC-coated dressings.

NCT ID: NCT04843618 Not yet recruiting - Pressure Ulcer Clinical Trials

Prevalence and Risk Factors of Pressure Ulcers in Beni Suef Governorate of Egypt

Start date: May 1, 2021
Phase:
Study type: Observational [Patient Registry]

the study aims at examining the relation between the prevalence and risk factors of pressure ulcers among hospitalized patients in Beni Suef governorate of Egypt

NCT ID: NCT04815798 Not yet recruiting - Pressure Ulcer Clinical Trials

Phage Therapy for the Prevention and Treatment of Pressure Ulcers.

Start date: January 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate a topical bacteriophage therapy product (BACTELIDE) as an adjunct to standard therapy for the prevention and treatment of pressure ulcers colonized with S. aureus, P. aeruginosa, or K. pneumoniae species. This study will compare the safety and efficacy of BACTELIDE in conjunction with standard of care (SOC) versus a placebo in conjunction with standard of care.

NCT ID: NCT04266808 Not yet recruiting - Clinical trials for Spinal Cord Injuries

Interactive Telehealth for Wheelchair Users

Start date: March 2020
Phase: N/A
Study type: Interventional

During typical daily activity, people with established spinal cord injury perform significantly fewer pressure-relief maneuvers than the recommended frequency while overestimating their adherence on recall surveys of pressure relief activity. The rate of pressure ulcer recurrence in individuals with a prior ulcer is 44% in those with surgical repair and as high as 75% in those with non-surgical healing indicating that increased attention to pressure relief is critical for these individuals.This study will evaluate the efficacy of a wheelchair sensor and app-based biofeedback for establishing healthy self-management behaviors (pressure relief maneuvers and daily physical activity). Investigators will enroll 50 participants with paraplegia from spinal cord injury who use a manual wheelchair for mobility and have a history of pressure ulcer that has healed or is six months post-surgical repair. Participants will be randomized into one of two groups: an intervention group that will receive an education intervention and the proposed technology to be used for one year, and a control group that will receive only the education intervention. The primary outcome will be pressure ulcer occurrence over one year. Investigators hypothesize that participants receiving the intervention of biofeedback on their pressure relief activity will have a lower recurrence of pressure ulcer than the education only control group. Secondary outcomes include depressive symptoms, self-efficacy, participation and satisfaction with life. Investigators hypothesize that increasing physical activity will reduce depressive symptoms and improve participation and satisfaction with life.

NCT ID: NCT03557489 Not yet recruiting - Pressure Ulcer Clinical Trials

Effectiveness of Sacral Foam Pad in Preventing Pressure Injury in Surgical Patients With Supine Position

Start date: June 16, 2018
Phase: N/A
Study type: Interventional

In surgical patients, prevention of pressure injury is a challenge because of the high risk for multiple comorbid conditions, hemodynamic instability, and long duration of immobility. The objectives of our study is to compare the difference in incidence rates of sacral pressure injury in surgical patients with supine position more than 3 hours between those treated with usual preventive care and a sacral foam pad versus a control group receiving usual care.

NCT ID: NCT02348294 Not yet recruiting - Clinical trials for Diabetes Mellitus Type 2

The Effect of Shear- Force at the Skin in Patients With Diabetes Mellitus

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

1. The objective of this study is to acquire knowledge about the development of reactive hyperaemia and inflammatory responses of the skin after shear- force and pressure loading. We want to investigate if patients with diabetes type 2 will develop more skin damage, because of a decreased microvascular function. 2. The second objective of this study is: to investigate if the cytokine production of the skin is increased in patients with type 2 diabetes with a history of Charcot osteoarthropathy in comparison with patients with neuropathy without a history of Charcot osteoarthropathy. The participant is asked to put his left arm on a support cushion. Then we mark an area of 2.5 cm x 3 cm with a permanent marker at the plantar aspect of the left fore-arm and the adhesive side of a Sebutape is placed within this area for collection of IL-1α/ total protein concentrations in a non- loaded situation (event 1) for two minutes. Second, we measure the cutaneous blood cell flux within the borders of the marked area with a Laser doppler. Finally, we measure the erythema index in this area with a colorimeter. Then we place the shear- pad over the marked area we apply 9,8 Newton (N) pressure with 19 N shear- force for half an hour. After this period a new Sebutape is placed for two minutes, followed by cutaneous blood cell flux and the erythema index measurement within the borders of the marked area. We repeat these measures after 15 minutes, 30 minutes, 45 minutes and 60 minutes, At the same time we performed the same experiment at the right arm, but instead of loading this arm with shear- force and pressure, we apply only 9,8 N pressure at this arm. The same measures with the sebutape, laser doppler and colorimeter are done before and after loading of the skin. The measures are repeated at 15 minutes, 30 minutes, 45 minutes and 60 minutes.

NCT ID: NCT02279355 Not yet recruiting - Clinical trials for Postoperative Pressure Ulcer

Peri-operative Risk Factors for Postoperative Pressure Ulcer in Surgical Patients

Start date: October 2014
Phase: N/A
Study type: Observational

The aim of this retrospective study is to overall evaluate and validate preoperative and intra-operative risk factors for postoperative pressure ulcers in critically ill postoperative patients.

NCT ID: NCT01734109 Not yet recruiting - Pressure Ulcers Clinical Trials

Efficacy of Quantum NPWT With Simultaneous Irrigation on Reduction of Wound Volume in Stage III/IV Pressure Ulcers.

Start date: December 2012
Phase: Phase 4
Study type: Interventional

Negative-pressure wound therapy (NPWT) is an important adjunct for management of wounds, and promotes granulation tissue and angiogenesis. Despite these known means for facilitation of wound management, further research is needed to examine whether this modality is superior to other currently used options, thus defining clear indications for and benefits of NPWT. This would also help establish the role of combination therapy, using NPWT with simultaneous irrigation or other forms of dressings. This study aims to compare treatment efficacy of NPWT, NPWT plus proprietary simultaneous irrigation, and traditional hospital standard of care for treatment of grade III & IV pressure ulcers. Primary endpoint of this study is comparison of reduction of wound volume between the three treatment arms; and secondary endpoints include bacterial load, rate of wound healing, preparation for grafting, and pain.