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Diabetic Foot Ulcers-VM202 - Healing Genes
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Diabetic Foot Ulcers-VM202

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Safety and Efficacy Study of VM202 in the Treatment of Chronic Non-Healing Foot Ulcers

A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of VM202 to Treat Chronic Nonhealing Foot Ulcers in Diabetic Patients With Concomitant Peripheral Arterial Disease (PAD)


Phase 3

DESCRIPTION:

Researchers at several locations are recruiting participants with chronic nonhealing foot ulcers to trial an investigatory drug. The drug is a loop of DNA, or plasmid, encoding genes for human hepatocyte growth factor (HGF) that produces proteins to promote growth of blood vessels and nerves.

The investigational treatment or a placebo (you will not know which) will be delivered by intramuscular injections, then follow up for 7 months to assess wound closure.


PATIENT MUST:

  • Be 18 to 80 years of age
  • Documented symptomatic Peripheral Artery Disease and diabetes
  • Not have a fracture, evidence of infection, or critical ischemia in the target foot

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Injection of the investigatory drug to the muscle.
  3. Standard care of the wound otherwise.
  4. Follow up on healing of the wound for 7 months.

LOCATIONS AND CONTACTS:
There are many study sites. Find a location near you.

Contacts:
Sheila Yi  |  [email protected]
 
SPONSOR INFORMATION:
Helixmith Co., Ltd.
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT02563522

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