Wound Care Institute of Ocean County Recruiting Venous Leg Ulcer Patients for New Clinical Trial
February 24, 2017
Wound Care Institute to participate in new clinical trial, sponsored by Factor Therapeutics, Ltd., for those suffering from chronic venous leg ulcers.
TOMS RIVER, NJ – Dr. Matthew Regulski, D.P.M., the Director of the Wound Care Institute of Ocean County, announces a new clinical trial for those suffering from chronic venous leg ulcers. Those interested in participating in the study should call the Wound Care Institute of Ocean County immediately at 732-736-5509.
The study, officially titled "A Prospective, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial Comparing Two Doses of VF001-DP to Placebo as an Adjunct to Standard Care in Patients with Chronic Venous Leg Ulcers," is being sponsored by Factor Therapeutics Ltd., alongside the following collaborators: Parexel, ARANZ Medical and Almac Clinical Services LLC.
"The objective of this study is to demonstrate the effectiveness and safety of VF001-DP as an adjunct to standard care (SC) in the treatment of chronic venous leg ulcers (VLUs) compared to placebo with SC over the course of the 12-week Treatment Phase," according to ClinicalTrials.gov (Identifier: NCT02973893).
This clinical trial is targeted at the following conditions: Ulcers, leg ulcers, varicose ulcers, pathologic processes, skin ulcers, skin diseases, varicose veins, vascular diseases and cardiovascular diseases, and will consist of three phases: Screening (two weeks), treatment (12 weeks and follow-up (12 weeks). Only patients whose study ulcer does not exhibit more than 30 percent change (increase or decrease) in ulcer size post-debridement between the screening phase visit (S1) and the treatment phase visit (T1) and who continue to meet eligibility criteria at the treatment phase visit (T1) will be randomized to receive either the Active Treatment Group (VF001-DP low or high dose plus standard care) or the Control Treatment Group (placebo plus standard care) in a ratio of 1:1:1, according to ClinicalTrials.gov.
"This study will help us determine if this new course of treatment improves wound healing in chronic venous leg ulcers compared to standard care alone," said Regulski. "Anyone with an ulceration between their knee and their ankle may be a candidate for this study and is encouraged to contact our office immediately to discuss this exciting new biological treatment."
This clinical trial plans to recruit 168 patients (56 per treatment group) at 26 centers in the United States, including the Wound Care Institute of Ocean County. To enroll in this study or to check eligibility requirements, please call the Wound Care Institute of Ocean County at 732-736-5509.
About the Wound Care Institute of Ocean County
The Wound Care Institute of Ocean County is the leader in wound care management, and is dedicated to the diagnosis and successful treatment of chronic and debilitating wounds. The Wound Care Institute follows the highest levels of evidence-based medicine and offers various treatment algorithms using the most advanced cellular therapies, as well as vascular services and surgical reconstruction. The Wound Care Institute of Ocean County is also involved in multiple clinical trials that have tremendous impact on the way wound healing is performed. To learn more, visit woundcareinstituteofoceancounty.com.