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Wounds - ISSN: 1044-7946 - Volume 18 - Issue 7 - July 2006 | |
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| Laura L. Bolton, PhD, FAPWCA |
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| Iakovos N. Nomikos, MD, FACS;1 Constantinos Malizos, MD;2
Nicholas C. Vamvakopoulos, PhD3 |
Abstract: Activation of the healing sequence may be successful or unsuccessful and most frequently leads to life-protective developments. Less frequently, it can lead to damage and life-threatening developments. The selection between protective and damaging healing modes appears to be dependent on the activation of eutopic or ectopic elements of the healing cascade. Systematic, functional staging of the healing process will aid decisively in identifying potent activators of the normal healing cascade and intervene successfully in favor of its protective, self-corrective direction.
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A Phase III Study to Evaluate the Safety and Efficacy of Recombinant Human Epidermal Growth Factor (REGEN-Dô 150) in Healing Diabetic Foot Ulcers |
| Vijay Viswanathan, MD, PhD;1 Sharad Pendsey, MD, MDDG;2
N. Sekar, MS, MNAMS, MCh, FICS;3 G.S.R. Murthy, PhD4 |
Abstract: A phase III clinical trial was carried out to determine the safety and efficacy of recombinant human epidermal growth factor (rhEGF 150 mg/g; REGEN-Dô 150, Bharat Biotech International Limited, Hyderabad, India) in healing diabetic foot ulcers. The study was a randomized, double-blind, multicenter, parallel study divided into 2 groups. The test group was administered the study drug, and the control group was administered placebo. Skin biopsy was done at baseline and after treatment to evaluate the degree of healing. Parameters, such as increase in collagen tissue, granulation tissue formation, skin epithelization, and microbial growth, were analyzed. The study data was subjected to statistical analysis to determine the significance between the test and the control groups. In the gel-treated group, at the end of 10 weeks, 69% of the ulcers healed, while in the placebo group, only 21% healed in 10 weeks. The study showed that patients with diabetic foot ulcers treated with rhEG
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Lack of Reliability of Clinical/Visual Assessment of Chronic Wound Infection: The Incidence of Biopsy-Proven Infection in Venous Leg Ulcers |
| Thomas Serena, MD;1 Martin C. Robson, MD;2 Diane M. Cooper, PhD;3 Jason Ignatius, MS-3,1 on behalf of the Human Genome Sciences Clinical Trial Group |
Abstract: Introduction: A practical method for diagnosing wound infection in venous leg ulcerations is problematic. The majority of physicians still rely on the classic signs and symptoms of infection. However, in a recent study, these physical findings were found to be unreliable or absent altogether. The gold standard for the diagnosis of infection is having > 105 colony-forming units (cfu) per gram of tissue on a quantitative biopsy. However, quantitative biopsies are difficult to perform, invasive, painful, and expensive. As a result, they are rarely performed in wound clinics in the United States. The authors examined the quantitative biopsy results from a large clinical trial to determine the accuracy of clinical examination in making the diagnosis of infection in venous leg ulcerations. Methods: Data from the Human Genome Sciences phase IIB multicenter clinical trial were analyzed. This prospective, randomized, placebo-controlled trial was designed to test the safety and efficac
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