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Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers

2016-07-21 02:23:21 | BioPortfolio

Summary

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

Description

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Venous Ulcer

Intervention

Artacent Human Amniotic Membrane, Standard of Care

Location

Foot & Ankle Center of Nebraska
Omaha
Nebraska
United States
68114

Status

Not yet recruiting

Source

Tides Medical

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-07-21T02:23:21-0400

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Medical and Biotech [MESH] Definitions

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.

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