Ulcers Related to Diabetic Foot Syndrome Clinical Trial
Official title:
Safety and Efficacy Study of Pl-vegf165 to Treat Diabetic Foot Syndrome
The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in the treatment of ulcers related to diabetic foot syndrome
This is a open clinical trial assessing the therapeutic efficacy of pl-vegf165
(Neovasculgen) in treating ulcers related to diabetic foot syndrome. Each patient will
undergo several intramuscular injections with a treatment dose of pl-vegf165 (Neovasculgen)
in calf of affected extrimity.
Study participants at the first study visit will complete study questionnaires, their foots
will be assessed clinically for ulceration. After this initial assessment, the patients will
undergo intramuscular injections of pl-vegf165 (Neovasculgen) in a calf altered with ulcers
due to diabetic foot syndrome.
At three month post-injection, the patient will complete study questionnaires, their foots
will be assessed clinically for ulceration, and their foots will undergo non-invasive
transcutaneous oximetry measurement. At six months post-injection, the patient will again
complete study questionnaires, their foots will be assessed clinically for ulceration and
will undergo non-invasive transcutaneous oximetry measurement.
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