Track topics on Twitter Track topics that are important to you
Patients with diabetes may develop chronic wounds that respond poorly to treatment. Gene therapy with the platelet-derived growth factor-B gene has been shown to help with the healing of chronic wounds. This study will evaluate a new way to deliver the gene to the wound tissue.
Chronic wounds, such as diabetic ulcers, pressure ulcers, and venous stasis ulcers, cause significant morbidity in millions of patients each year in the United States. Individuals with long-standing diabetes develop both peripheral vascular disease and peripheral neuropathy. These patients may not feel pressure from shoes or objects which can damage their skin. Once a wound is formed, it may heal very slowly or not at all due to diabetic complications.
Platelet-derived growth factor-B (PDGF-B) has been approved for use in diabetic ulcers. However, delivery and maintenance of the drug at the wound site in sufficient quantities for a sufficient period of time is a major hurdle to widespread use.
Gene activated matrix (GAM) technology offers the opportunity to place a therapeutic gene contained within a structural matrix into a wound site. This study will evaluate the safety and potential clinical utility of topical applications of GAM501, a gene for PDGF-B contained within an E1-deleted adenoviral vector and formulated in a bovine type I collagen gel. This formulation allows for the migration of wound repair cells into the structural matrix, where they encounter the viral vector and subsequently produce the therapeutic protein within the local wound environment.
Participants in this study will receive up to four treatments with GAM501. Participants will be followed by multiple observations over a 6 to 7 month period.
Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Wounds and Injuries
Foot and Ankle Medical Center
Tissue Repair Company
Published on BioPortfolio: 2014-08-27T03:55:05-0400
This is a Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of one or two applications of topically applied GAM501 (Ad5PDGF-B/Bovine Type I C...
The objective of this study is to evaluate the performance of Polyheal-1 compared to Saline in the treatment of recalcitrant wounds including venous, post-operative and post-traumatic chro...
Extremity wounds and fractures constitute the majority of war-associated traumatic injuries, both for civilians and combatants. War-associated injuries are often contaminated with foreign ...
The aim of the study is to evaluate the performance of DURAFIBER Ag and to assess how many bacteria are present in infected wounds over an 8 week period.
This is a double blind placebo-controlled RCT comparing the speed of healing of simple traumatic wounds with Aloe Vera gel compared to both control (Ultrasound gel) and standard care.
Historically, head and neck injuries constituted 16 to 20% of all nonfatal combat injuries. However, advances in body and vehicle armor in the context of the use of ambushes and improvised explosive d...
Since the start of the conflict in the Middle East in 2001, military orthopedic surgeons have faced complex orthopedic injuries including high-energy soft tissue wounds, traumatic amputations, and ope...
The spectrum of injury associated with anterior abdominal stab wounds (SWs) is well established. The literature in the specific setting of isolated omental evisceration is limited.
Chronic nonhealing wounds represent a significant clinical problem and cost the healthcare system $19 billion annually. Recently, Vågesjö et al. (2018) demonstrated a promising therapeutic approach...
Wars and injuries have accompanied mankind throughout history. Physicians and surgeons from various civilizations made difficult attempts to manage wounds and injuries. Among various civilizations, th...
Head injuries which feature compromise of the skull and dura mater. These may result from gunshot wounds (WOUNDS, GUNSHOT), stab wounds (WOUNDS, STAB), and other forms of trauma.
WOUNDS and INJURIES and PSYCHOLOGICAL TRAUMA sustained during WAR.
Penetrating stab wounds caused by needles. They are of special concern to health care workers since such injuries put them at risk for developing infectious disease.
Penetrating and non-penetrating injuries to the spinal cord resulting from traumatic external forces (e.g., WOUNDS, GUNSHOT; WHIPLASH INJURIES; etc.).
Injuries caused by impact with a blunt object where there is no penetration of the skin.
Bioinformatics is the application of computer software and hardware to the management of biological data to create useful information. Computers are used to gather, store, analyze and integrate biological and genetic information which can then be applied...
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...