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This study will compare the proportion of patients who have wound closure within 12 weeks as well as the time to wound closure in patients receiving Artacent™ versus standard of care for treatment of non-healing lower extremity wounds. The recurrence of healed wounds will be assessed at 6 months via a telephone survey
This study is to document the efficacy of Artacent™ Human Amniotic Membrane (Artacent) in the treatment of diabetic and vascular lower extremity ulcers. The study will add to the currently available literature by also assessing the impact of treatment on quality of life and on heal economic outcomes. Finally the study will follow patients for longer than previous studies and will obtain data on healing and recurrence at 6 months.
The objectives of this study are 1) to compare Artacent to standard of care (SOC) in the treatment of non-healing lower extremity ulcers and 2) to evaluate the impact of treatment on patient quality of life. Health economic outcomes will also be collected. The proportion of patients receiving Artacent who have wound closure with 12 weeks will be compared to those patients receiving SOC only will be compared. A comparison of time to wound closure will also be compared between the two populations.
Patients who are randomized to the SOC group (control) and require further treatment at 12 weeks due to incomplete wound healing, may receive treatment with Artacent if the investigator determines that to be a potentially beneficial option.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Artacent Human Amniotic Membrane, Standard of Care
Foot & Ankle Center of Nebraska
Not yet recruiting
Published on BioPortfolio: 2016-07-21T02:23:21-0400
To evaluate the using of a commercial product of dried human amniotic membrane sterilized by gamma irradiation for the treatment of skin ulcer.
This is a randomised trial that aims to evaluate whether a transient skin cover made out of human amniotic membranes is effective in managing burns among pediatric patients. The primary ou...
This is a multi-center, randomized controlled trial designed to evaluate the use of fresh hypothermically stored human amniotic membrane (Affinity; fHSAM) to determine if addition of fHSAM...
A retrospective study including 22 patients who have undergone amniotic membrane transplant in our unit up till 2016. Confocal microscopy and anterior segment optical coherence tomography ...
The purpose of this study is to compare the effectiveness of standard venous ulcer care to standard venous ulcer care plus a cell based product made from the patients own blood. This prod...
In May 2018, BSN Medical hosted a symposium, 'The management of venous leg ulcers: the value of high-quality care', at the European Wound Management Association (EWMA) conference in Poland. It focused...
Human amniotic membrane-derived mesenchymal stem cells (hAM-MSCs) are considered a new and favorable source of stem cells for cell replacement-based therapy. Some microRNAs (miRNAs) have been reported...
Various natural and synthetic biomaterials have been applied as skin substitutes for regenerating damaged skin. Here, we describe a straightforward method for fabrication of a tissue-engineered skin s...
In ophthalmology amniotic membrane is usually used for the treatment of corneal ulcerations and chemical burns of the ocular surface. Also, it is useful in the treatment of conjunctival defects. There...
To describe the use of cryopreserved ultra-thick human amniotic membrane for management of anophthalmic socket contracture.
Ulceration of the skin and underlying structures of the lower extremity. About 90% of the cases are due to venous insufficiency (VARICOSE ULCER), 5% to arterial disease, and the remaining 5% to other causes.
Impaired venous blood flow or venous return (venous stasis), usually caused by inadequate venous valves. Venous insufficiency often occurs in the legs, and is associated with EDEMA and sometimes with VENOUS STASIS ULCERS at the ankle.
Skin breakdown or ulceration caused by varicose veins in which there is too much hydrostatic pressure in the superficial venous system of the leg. Venous hypertension leads to increased pressure in the capillary bed, transudation of fluid and proteins into the interstitial space, altering blood flow and supply of nutrients to the skin and subcutaneous tissues, and eventual ulceration.
The minimum acceptable patient care, based on statutes, court decisions, policies, or professional guidelines.
Incompetent UTERINE CERVIX is usually diagnosed in the second trimester of PREGNANCY. It is characterized by passive painless cervical dilation in the absence of UTERINE CONTRACTION; BLEEDING; INFECTION; and sometimes with the amniotic sac (AMNIOTIC MEMBRANE) bulging through the partially dilated cervix. Left untreated, this condition may lead to premature pregnancy loss, such as HABITUAL ABORTION.
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...
Complementary and Alternative Medicine
Alternative medicine are whole medical systems that did not fit with conventional medicine as they have completely different philosophies and ideas on the causes of disease, methods of diagnosis and approaches to treatment. Although often overlapping, co...
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...