Neurotrophic UlcersPhase 2SETESNCT01884831
The Study of the Effectiveness of Tissue Equivalent on the Basis of Cultured Cells to Heal Skin Blemishes
A Phase 2 study testing study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions in people with Neurotrophic Ulcers and Burns, run by Ural State Medical University at 1 site in Russia.
Trial summary
In Russia the treatment nonhealing skin defects often limited to surgical interventions, despite having developed modern methods of treatment of non-healing ulcers and other skin imperfections. During the many years of research we have developed a skin equivalent comprising living cells. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neurotrophic Ulcers, Burns
- What is being tested?
- study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteRussia
- Study dates
- Feb 2014to Jul 2018
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The presence of non-healing ulcer at least a month, an area of not less than 3 cm2 or smaller area of deep defects;
- Availability of burns II or III level;
- Epidermolysis bullosa;
- Availability of post-burn scars
- Defects in the skin after surgery
Who cannot join
- Acute and chronic diseases in the acute stage;
- Autoimmune diseases of connective tissue (collagen);
- Immunodeficiency states;
- System of inflammatory diseases of the skin;
- Conduct an aggressive corticosteroid therapy;
- Acute coronary syndrome;
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- Acute disorders of cerebral circulation;
- Availability of local inflammation in the acute stage;
- Pregnancy;
- Breast-feeding.
- Positive results of the following tests: Anti-HIV-1 and -2, HIV-1Ag, anti-HTL VI and-II, anti-HbcorAg, HBs-Ag, anti-HCV, anti-CMV, anti-Toxoplasma gondii, RW, Neisseria gonorrheae, Chlamydia.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Ural State Medical Academy
Yekaterinburg, 620028
Arteom V Korotkov, PhD
About this study
Official title: Phase 2 The Use of Tissue-equivalent Based on Cultured Cells for Healing Skin Blemishes
In Russia the treatment nonhealing skin defects often limited to surgical interventions, despite having developed modern methods of treatment of non-healing ulcers and other skin imperfections. During the many years of research we have developed a skin equivalent comprising living cells.
During pilot trial showed that the skin equivalent provides healing skin defect within 1-4 weeks in 95% of patients.
- Conditions
- Neurotrophic Ulcers, Burns
- Being tested
- study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions
- Keywords
- damage to the skin, the skin equivalent, cell therapy
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesionsBiological
| Study group | Role | What they receive |
|---|---|---|
| cell therapy | Experimental | study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions Receives: Biological: study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficiency
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startFeb 2014
- Primary completionJul 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurotrophic UlcersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ural State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Korotkov Artem Vladimirovich, Ural State Medical University
- Investigators
- Oleg G Makeev, MD, Study chair, Ural State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884831
- Sponsor's protocol ID
- USMA01082012
- Acronym
- SETES
- Status last verified
- Dec 2013
- First submitted
- 19 Jun 2013
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 The Use of Tissue-equivalent Based on Cultured Cells for Healing Skin Blemishes
- ClinicalTrials.gov ID
- NCT01884831
- Acronym / sponsor ID
- SETES / USMA01082012
- Conditions
- Neurotrophic Ulcers, Burns
- Keywords
- damage to the skin, the skin equivalent, cell therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Ural State Medical UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 24 Jun 2013 (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.
In Russia the treatment nonhealing skin defects often limited to surgical interventions, despite having developed modern methods of treatment of non-healing ulcers and other skin imperfections. During the many years of research we have developed a skin equivalent comprising living cells.
During pilot trial showed that the skin equivalent provides healing skin defect within 1-4 weeks in 95% of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cell therapy | Experimental | Biological: study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesionsstudy of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The presence of non-healing ulcer at least a month, an area of not less than 3 cm2 or smaller area of deep defects;
- Availability of burns II or III level;
- Epidermolysis bullosa;
- Availability of post-burn scars
- Defects in the skin after surgery
Key exclusion criteria (11 listed)
- Acute and chronic diseases in the acute stage;
- Autoimmune diseases of connective tissue (collagen);
- Immunodeficiency states;
- System of inflammatory diseases of the skin;
- Conduct an aggressive corticosteroid therapy;
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 |
|---|---|---|
| study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions | Biological | cell therapy |
Primary outcome
efficiency
Time frame: six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
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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.
Oleg G Makeev, MD study chair
Ural State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions in people with Neurotrophic Ulcers and Burns, run by Ural State Medical University 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 12 Dec 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arteom V Korotkov (+73432421546, larim@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficiency (time frame: six weeks). 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 12 Dec 2013; AzTrials last refreshed its copy on 7 Nov 2026.