Trophic UlcerPhase 1/2NCT04483934
Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Autologous Dermal Fibroblasts
A Phase 1/2 study testing Dermal fibroblasts and LED phototherapy in people with Trophic Ulcer and Non-healing Wound, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
Trial summary
Treatment of patients with non-healing wounds and trophic ulcers using local LED phototherapy with local transplantation of autologous dermal fibroblasts Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trophic Ulcer, Non-healing Wound, Non-Healing Ulcer of Skin
- What is being tested?
- Dermal fibroblasts and LED phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelarus
- Study dates
- 28 Oct 2014to 30 Sep 2016
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trophic Ulcers
- Chronic non-healing wounds
Who cannot join
- acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
- mental disorders
- pregnancy
Trial locations and contacts
1 site in 1 country.
Belarus1 site
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, 220072
About this study
Official title: Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Local LED Phototherapy and Autologous Dermal Fibroblasts
Treatment of patients with non-healing wounds and trophic ulcers using local LED phototherapy with local transplantation of autologous dermal fibroblasts
Read the detailed description
During the implementation of the project, it was planned to develop a method for the treatment of trophic ulcers using injection of autologous dermal fibroblasts in the wound.
The positive outlook for the effectiveness of photodiode therapy with dermal fibroblasts is due to the following:
- the ability of fibroblasts to stimulate tissue regeneration
- positive results of preclinical studies of the method of treatment of long-term non-healing wounds in animals (rats).
Twelve patients were included in the study. Dermal fibroblasts were isolated from the skin patients, cultured and then transplanted back to the wound.
The therapeutic dose of cells was 50k per cm2 of the wound area. Follow up patients monitoring was performed at 1, 2 and more months after injection.
- Conditions
- Trophic Ulcer, Non-healing Wound, Non-Healing Ulcer of Skin
- Being tested
- Dermal fibroblasts, LED phototherapy
- Keywords
- Trophic Ulcer, Non-healing Wound, Dermal fibroblasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermal fibroblastsBiological
Cultured autologous dermal fibroblasts.
For PR: The name "dermal fibroblasts" is exactly the name of the cell product registered by our ministry of health. There is no trade or international name.
LED phototherapyDevice
LED phototherapy
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with dermal fibroblasts | Experimental | Cultured dermal fibroblasts and LED phototherepy Receives: Biological: Dermal fibroblasts; Device: LED phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with tropic ulcers cured
Number of patients cured
Measured: 1 month
Number of patients with treatment-related adverse events
Fibroblasts injection related adverse events assessed by blood count and function tests
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start28 Oct 2014
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trophic UlcerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Sponsor type
- Other government
- Collaborators
- Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
- Responsible party
- Sponsor
- Investigators
- Igor Volotovski, Prof, Study director, Head of the Lab of Institute of Biophysics and Cell EngineeringStanislav Tretyak, Prof, Study director, Head of 2nd Department of Surgical Diseases of BSMUEvgeny Baranov, Dr, Principal investigator, Ass prof of 2nd Department of Surgical Diseases of BSMUZinaida Kvacheva, Dr, Principal investigator, Lead Researcher of Institute of Biophysics and Cell Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483934
- Sponsor's protocol ID
- IBCE_Fibr(TrophicUlcer)
- Status last verified
- Jul 2020
- First submitted
- 17 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Non-healing Wounds and Trophic Ulcers Using Local LED Phototherapy and Autologous Dermal Fibroblasts
- ClinicalTrials.gov ID
- NCT04483934
- Acronym / sponsor ID
- IBCE_Fibr(TrophicUlcer)
- Conditions
- Trophic Ulcer, Non-healing Wound, Non-Healing Ulcer of Skin
- Keywords
- Trophic Ulcer, Non-healing Wound, Dermal fibroblasts
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOther government
- Collaborators
- Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
- Study start
- 28 Oct 2014 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 23 Jul 2020 (actual)
- 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.
Treatment of patients with non-healing wounds and trophic ulcers using local LED phototherapy with local transplantation of autologous dermal fibroblasts
Detailed description
During the implementation of the project, it was planned to develop a method for the treatment of trophic ulcers using injection of autologous dermal fibroblasts in the wound.
The positive outlook for the effectiveness of photodiode therapy with dermal fibroblasts is due to the following:
- the ability of fibroblasts to stimulate tissue regeneration
- positive results of preclinical studies of the method of treatment of long-term non-healing wounds in animals (rats).
Twelve patients were included in the study. Dermal fibroblasts were isolated from the skin patients, cultured and then transplanted back to the wound.
The therapeutic dose of cells was 50k per cm2 of the wound area. Follow up patients monitoring was performed at 1, 2 and more months after injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with dermal fibroblasts | Experimental | Biological: Dermal fibroblasts, Device: LED phototherapyCultured dermal fibroblasts and LED phototherepy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Trophic Ulcers
- Chronic non-healing wounds
Key exclusion criteria (3 listed)
- acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
- mental disorders
- pregnancy
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 |
|---|---|---|
| Dermal fibroblastsCultured autologous dermal fibroblasts. For PR: The name "dermal fibroblasts" is exactly the name of the cell product registered by our ministry of health. There is no trade or international name. | Biological | Patients treated with dermal fibroblasts |
| LED phototherapyLED phototherapy | Device | Patients treated with dermal fibroblasts |
Primary outcome
Number of patients with tropic ulcers cured
Time frame: 1 month
Number of patients cured
Number of patients with treatment-related adverse events
Time frame: 4 weeks
Fibroblasts injection related adverse events assessed by blood count and function tests
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 23 Jul 2020.
- Individual participant dataSharing planned: No
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.
Igor Volotovski, Prof study director
Head of the Lab of Institute of Biophysics and Cell Engineering
Stanislav Tretyak, Prof study director
Head of 2nd Department of Surgical Diseases of BSMU
Evgeny Baranov, Dr principal investigator
Ass prof of 2nd Department of Surgical Diseases of BSMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dermal fibroblasts and LED phototherapy in people with Trophic Ulcer and Non-healing Wound, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
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 2 inclusion and 3 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 23 Jul 2020. 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 Belarus. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Number of patients with tropic ulcers cured (time frame: 1 month). The study lists 2 primary outcomes in all. 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 23 Jul 2020.