NCT02538705

Brief Summary

The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in the treatment of ulcers related to diabetic foot syndrome

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 5, 2017

Status Verified

August 1, 2015

Enrollment Period

5 months

First QC Date

August 30, 2015

Last Update Submit

April 4, 2017

Conditions

Ulcers Related to Diabetic Foot Syndrome

Keywords

Diabetic foot syndromeUlcers

Outcome Measures

Primary Outcomes (1)

  • Area of diabetic foot ulcers

    To determine the ability of pl-vegf165 to facilitate and accelerate diabetic foot ulcers healing

    180 days

Secondary Outcomes (1)

  • Transcutaneous oxygen pressure

    180 days

Study Arms (1)

Neovasculgen

EXPERIMENTAL
Drug: Neovasculgen

Interventions

NeovasculgenDRUG
Also known as: pl-vegf165
Neovasculgen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • obtained voluntary informed consent for participation in the clinical study
  • presence of diabetic foot syndrome
  • presence at least one active ulcer at baseline

You may not qualify if:

  • Any disease that can, in the opinion of the treating physician, affect the outcome of the study
  • Patients with addictive disorders or substance abuse
  • Pregnancy or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Stem Cell Institute

Moscow, Russia

Location

MeSH Terms

Conditions

Ulcer

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2015

First Posted

September 2, 2015

Study Start

August 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 5, 2017

Record last verified: 2015-08

Locations

RU(1)