Ulcers Related to Diabetic Foot SyndromeNCT02538705
Safety and Efficacy Study of Neovasculgen (Pl-VEGF165) Gene Therapy in Patients With Diabetic Foot
A study testing Neovasculgen in people with Ulcers Related to Diabetic Foot Syndrome, run by Artgen Biotech at 1 site in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcers Related to Diabetic Foot Syndrome
- What is being tested?
- Neovasculgen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteRussia
- Study dates
- Aug 2015to 1 Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obtained voluntary informed consent for participation in the clinical study
- presence of diabetic foot syndrome
- presence at least one active ulcer at baseline
Who cannot join
- 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
- All other exclusion criteria listed in the summary of product characteristics (SmPC)
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
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.
- Conditions
- Ulcers Related to Diabetic Foot Syndrome
- Being tested
- Neovasculgen
- Keywords
- Diabetic foot syndrome, Ulcers
- Medical subject headings
- Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeovasculgenDrug
Also called pl-vegf165
| Study group | Role | What they receive |
|---|---|---|
| Neovasculgen | Experimental | Not described Receives: Drug: Neovasculgen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area of diabetic foot ulcers
To determine the ability of pl-vegf165 to facilitate and accelerate diabetic foot ulcers healing
Measured: 180 days
Secondary outcomes (1)
Transcutaneous oxygen pressure
To determine the ability of pl-vegf165 to improve blood circulation in affected extremity by angiogenesis inducing
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startAug 2015
- Primary completion1 Jan 2016
- Study completion1 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcers Related to Diabetic Foot SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artgen Biotech
- Sponsor type
- University, hospital or other
- Collaborators
- Ryazan State Medical University, Vidnoe District Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538705
- Sponsor's protocol ID
- NeoFoot Pilot Study
- Status last verified
- Aug 2015
- First submitted
- 30 Aug 2015
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Pl-vegf165 to Treat Diabetic Foot Syndrome
- ClinicalTrials.gov ID
- NCT02538705
- Acronym / sponsor ID
- NeoFoot Pilot Study
- Conditions
- Ulcers Related to Diabetic Foot Syndrome
- Keywords
- Diabetic foot syndrome, Ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Artgen BiotechUniversity, hospital or other
- Collaborators
- Ryazan State Medical University, Vidnoe District Hospital
- Study start
- Aug 2015 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jan 2016 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in the treatment of ulcers related to diabetic foot syndrome
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neovasculgen | Experimental | Drug: Neovasculgen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- obtained voluntary informed consent for participation in the clinical study
- presence of diabetic foot syndrome
- presence at least one active ulcer at baseline
Key exclusion criteria (4 listed)
- 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
- All other exclusion criteria listed in the summary of product characteristics (SmPC)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeovasculgenAlso: pl-vegf165 | Drug | Neovasculgen |
Primary outcome
Area of diabetic foot ulcers
Time frame: 180 days
To determine the ability of pl-vegf165 to facilitate and accelerate diabetic foot ulcers healing
1 secondary outcome
Transcutaneous oxygen pressure
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neovasculgen in people with Ulcers Related to Diabetic Foot Syndrome, run by Artgen Biotech at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area of diabetic foot ulcers (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.