UC Davis Health Clinical Studies

A Study of Experimetnal VarIthena on Wound Healing in Venous Leg Ulcers (VLU)

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The purpose of this registry is to look at how experimental Varithena® injectable foam works. It will be given to patients who have chronic venous insufficiency (commonly known as “varicose veins”) with leg wounds. The decision to provide you with such medication has been left up to your treating physician and is not being driven by or impacted by this study. The purpose of this project is to collect data about your leg wounds. We hope to learn the impact of treatment on the rate of healing, the rate of repeated wounds, as well as the impacts to your level of pain and quality of life.

Drug study
Any, age 18 years or older

A Study of Experimental Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Eczema)

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This study will test the effectiveness and safety of the experimental study drug upadacitinib (ABT-494). It will be compared to a placebo, which is an inactive substance that looks like the study drug. Experimental ABT-494 is being tested for the treatment of moderate to severe atopic dermatitis (AD). The study drug is an oral medication (taken by mouth) that is a tablet taken once a day. An experimental drug is one that has not been approved by the FDA.

Drug study, Phase 3
Any, age 12 to 75 years old

A Study of the Experimental Prevena™ device (Incisional Negative Pressure Wound Therapy) for Soft Tissue Sarcoma Wounds

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Patients with sarcomas (tumor in bone or soft tissue) who receive radiation before surgery have a greater chance of complications in wound healing. This research study will test a wound dressing called Negative Pressure Wound Therapy (NPWT). NPWT is a wound sponge attached to a gentle suction device. It is more effective at preventing infection of the surgical wound than standard dry gauze wound dressing. The Prevena™ device (NPWT) is FDA approved for use on incisions. This will be considered the investigational dressing. The NPWT device is a foam sponge that is placed over the incision after surgery, and provides a low pressure gentle suction on the wound. It is sealed with an adhesive dressing. The traditional standard dry gauze dressing will be considered the control dressing for this study

Device study
Any, age 18 years or older

A Study of Experimental Blood Derived Autologous Angiogenic Cell Precursor (type of stem cell) Therapy for Critical Limb Ischemia

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Peripheral Artery Disease (PAD) is a common, progressive circulatory disease. It sometimes advances to Critical Limb Ischemia (CLI). CLI symptoms can be painful and lead to sores and in some cases amputation. This study will test the safety and effectiveness of injecting Angiogenic Cell Precursors (ACPs) into the muscles of your leg and foot. ACPs are specific stem cells collected from your blood. This experimental study treatment will be used to relieve symptoms of Critical Limb Ischemia.

Biological study, Phase 2
Any, age 18 years or older

A Study of Experimental PLX PAD for Critical Limb Ischemia (severely obstructed arteries limiting bloodflow to limbs)

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This study will test if experimental PLX-PAD is safe, well tolerated and effective for the treatment of critical limb ischemia (CLI). This study is for people with CLI, who are not considered good candidates for surgery or other procedures designed to increase blood flow. CLI is a severe form of peripheral artery disease (PAD). It is caused by atherosclerosis (hardening of the arteries due to plaques in their inner walls). When the blood vessels that supply blood to the leg narrow, this leads to insufficient blood and oxygen supply to the leg tissues. CLI may be characterized by pain in the foot or leg even when lying at rest. It can also involve foot and leg wounds, which sometimes lead to infection and tissue death. This may lead to the amputation of toes, foot or leg. PLX-PAD is an experimental medicine. This means that it is not approved for use by the FDA, other than in research studies. PLX-PAD is a cellular therapy, meaning that it contains living cells which are injected into the patient’s muscles. These cells come from a human placenta (the organ that connects the fetus to the uterus). It is collected in a sterile procedure during a planned cesarean section, from healthy female volunteers who donated it. All placenta donors complete a comprehensive questionnaire on their risk of being infected or being a carrier of infectious diseases. Their blood is tested for a vast panel of infectious diseases. Since this research uses human cells, the process for obtaining the cells and preparing them for use is subject to the highest standards. PLX-PAD cells are added to a fluid which contains: - dimethyl sulfoxide (DMSO), - human serum albumin (human blood protein) - PlasmaLyte (salts solution). The control solution contains: - dimethyl sulfoxide (DMSO), - human serum albumin (human blood protein) - PlasmaLyte (salts solution) The control solution does not contain the PLX-PAD cells and is not expected to make your disease better.

Biological study, Phase 3
Any, age 45 to 99 years old

A Randomized Trial Comparing Monocryl(absorbable) vs. Nylon (traditional) Suture Closure in Carpal Tunnel Surgery

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This research study hopes to determine if there is a significant difference in using two different types of sutures (stitches): - subcuticular (under the skin) Monocryl (absorbable) vs - traditional Nylon sutures (stitches) These sutures will be used after open carpal tunnel decompression surgery. Both types of suture are commonly used in clinical practice. There is no objective data about which is “better”.

Procedure study
Any, age 18 years or older

A Study of the Experimental Medicine Baricitinib (LY3009104) in Adults With Moderate to Severe Atopic Dermatitis

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The main reason for you to take part in this study is to help in answering the following research questions: • How experimental baricitinib (LY3009104) compares with placebo in helping patients with atopic eczema. • The safety of baricitinib and any side effects you might have when you take it. “Experimental” means that the drug being tested has not been approved for routine clinical use or for the use described in this study by the FDA. The FDA is allowing the use of this drug for research.

Drug study, Phase 3
Any, age 18 years or older
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