The Prospective, Double-blind, Multicenter, Placebo-controlled, Randomized, Comparative Clinical Trial

Recruiting Phase 3 Interventional Study
Ulcer Foot Mellitus Diabetes
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
144 (estimated)
Sponsor
JSC NextGen · Other
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About This Trial

The main objective of the study is to evaluate the efficacy and safety of Neovasculgen® in a course dose of 2.4 mg in combination with standard drug therapy in patients with unilateral neuroischemic form of diabetic foot syndrome.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male and female patients aged 18 years and above inclusive (at the time of study entry) with neuroischemic form of diabetic foot syndrome. 2. Type 1 or type 2 diabetes mellitus. 3. Prolonged non-healing ulcerative defect on the background of standard therapy (at least 1 month…
Contacts

Viktoria

+79602952607

dorozhkova.viktoria@mail.ru

CONTACT