Diabetic Foot UlcerPhase 1/21ABCNCT03865394
Treatment of Chronic Wounds in Diabetic Foot Syndrome With Allogeneic Adipose Derived Mesenchymal Stem Cells
A Phase 1/2 study testing Application of allogeneic ADSC stem cells in fibrin gel in people with Diabetic Foot Ulcer, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aim of this study is to investigate efficiency of applying of adipose-derived mesenchymal stem cells (ADSC) in treatment of chronic wounds in diabetic foot syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Application of allogeneic ADSC stem cells in fibrin gel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2019to 30 Sep 2021
- 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
- Signing informed consent form.
- Above the age of 18
- Voluntary participation in the research, following the requirements of the protocol and acceptance for procedures related with its implementation
- Chronic wound in the course of diabetic foot syndrome, with the wound surface between 1 - 25 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study
- Blood level of glycated haemoglobin (HbA1c) <=11%
- Satisfactory blood supply to the wound verified by the measurement of the oxygen level in the foot tissue (>=30 mmHg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (>=50 mmHg) of the affected limb.
- General health condition, which according to the investigator's opinion, allows patient's participation in all study procedures.
Who cannot join
- Lack of patient's cooperation
- Wound etiology other than diabetic foot syndrome
- Clinicaly significant limb ischemia as verified by the measurement of the oxygen level in the foot tissue (<30 mmHg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (<50 mmHg)
- Active wound infection, which would require the treatment with antibiotics
- Known allergy to ingredients of study product (thrombin, penicillin).
- Active venous thromboembolism
- Any systemic disease (acute or chronic) in the stage of exacerbation or not stabilized, that in the opinion of the investigator may hinder or make impossible a patient's participation in the study
- Active cancer during chemotherapy or radiotherapy, or recent cancer, if the remission occured less than 5 years before joining the study
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Warsaw, Department of Diabetology and Internal Diseases
Warsaw
About this study
Official title: Evaluation of the Safety and Efficacy of the Treatment of Chronic Wounds in Diabetic Foot Syndrome With the Use of Allogeneic Stem Cells Isolated From Adipose Tissue
The aim of this study is to investigate efficiency of applying of adipose-derived mesenchymal stem cells (ADSC) in treatment of chronic wounds in diabetic foot syndrome.
Read the detailed description
The product will contain an active ingredient- human allogeneic adipose-derived mesenchymal stem cells (ADSC) cells suspended in the fibrin solution applied directly onto prepared wound bed, to form thin gel layer on the wound surface.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Application of allogeneic ADSC stem cells in fibrin gel, Standard care in diabetic foot ulcer
- Keywords
- stromal vascular fraction, adipose-derived mesenchymal stem cells, chronic wounds, diabetes, foot ulcer
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of allogeneic ADSC stem cells in fibrin gelBiological
Chronic wounds in diabetic foot ulcer will be covered with ADSC suspended in fibrin gel - single dose will be administered followed by weekly wound control.
Standard care in diabetic foot ulcerProcedure or surgery
Chronic wounds in diabetic foot ulcer will be covered with fibrin gel followed by weekly wound control.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic ADSC cells in fibrin solution | Experimental | Application of allogeneic ADSC stem cells in fibrin gel, to cover wound surface with thin cells layer.
Therapy is based on standard procedure of diabetic foot ulcer treatment combined with application of allogeneic ADSC stem cells in fibrin solution onto the wound surface. Receives: Biological: Application of allogeneic ADSC stem cells in fibrin gel |
| Standard care in diabetic foot ulcer with aplication of fibrin gel to cover wound surface. | Active comparator | Application of fibrin gel to cover wound surface. Receives: Procedure: Standard care in diabetic foot ulcer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in wound size
The comparison of the time required for the 50% reduction of initial wound size between patients in both study arms.
The wound size changes will be assessed using digital 3D wound imaging medical device with image processing software, according to the following rules:
- for wounds deeper than 0.5 cm - measurement of wound volume, or
- for shallow wounds (less than 0.5 cm depth) - measurement of wound surface.
Measured: 8 weeks
Secondary outcomes (5)
Changes in wound morphology
Clinical assessment of wound morphology (and its changes during the treatment) in each treated patient, as well, as between patients in both study arms, expressed as:
- the amount (1) and features (2) of wound exudate,
- the presence of redness (3) and/or edema (4) in the wound surrounding skin,
- the presence of granular tissue and fibrin (5) or epithelium (6) in the wound bed.
The listed parameters will be assessed using simplified questionnaire adopted from Bates-Jensen Wound Assessment Tool (positions 7-13 from B-JWAT).
Each of 6 abovementioned features will be assessed semiquantitatively using 1-5 points scale, (with "1" for a best state, and "5" for a worst state). The sum of points allocated to each parameter will be recorded as the wound score and used for further analysis.
The healthy skin/healed wound should receive 6 points, whereas active wound, with exudate and inflammation will receive 30 points (the lower = the better / the higher = the worse).
Measured: 8 weeks
Changes in pro-angiogenic factors expression
Evaluation of the expression (and its changes during the treatment) of selected pro-angiogenic factors, measured in wound biopsies.
The changes will be analyzed for each tested individual separately, and compared between both study arms.
Measured: 8 weeks
Changes in wound-associated pain
Evaluation of the wound-associated pain, assessed by the patient using visual analogue scale. The minimum value is 0 and means "no pain" and the maximum value is 10 and means "the worst possible pain". The lower value the better outcome.
The changes will be analyzed for each tested individual separately, and compared between both study arms.
Measured: 8 weeks
Changes in the quality of life
Evaluation of the patient's quality of life, assessed by the dedicated QoL questionnaire. The QoL questionnaire consists of 10 questions. Each question is scored 1 to 5. The minimum score is 10 and it means "the best possible state of health", and the maximum score is 50, which means ,,the worst possible state of health".
The changes will be analyzed for each tested individual separately, and compared between both study arms.
Measured: 8 weeks
Record of adverse events
Evaluation of the safety of ADSC application, assessed by the occurrence of any adverse events.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start1 Jul 2019
- Primary completion31 Mar 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Polish Stem Cells Bank S.A.
- Responsible party
- Sponsor
- Investigators
- Beata Mrozikiewicz-Rakowska, . Assoc.Prof., Principal investigator, Medical University of Warsaw, Department of Diabetology and Internal Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865394
- Sponsor's protocol ID
- 1ABC Therapy
- Other IDs
- 267976/13/NCBR/2015, 2016-004109-15, PL008125, Z4217, 2016
- Acronym
- 1ABC
- Status last verified
- Sep 2021
- First submitted
- 8 Nov 2018
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of the Treatment of Chronic Wounds in Diabetic Foot Syndrome With the Use of Allogeneic Stem Cells Isolated From Adipose Tissue
- ClinicalTrials.gov ID
- NCT03865394
- Acronym / sponsor ID
- 1ABC / 1ABC Therapy
- Conditions
- Diabetic Foot Ulcer
- Keywords
- stromal vascular fraction, adipose-derived mesenchymal stem cells, chronic wounds, diabetes, foot ulcer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Polish Stem Cells Bank S.A.
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 6 Mar 2019 (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.
The aim of this study is to investigate efficiency of applying of adipose-derived mesenchymal stem cells (ADSC) in treatment of chronic wounds in diabetic foot syndrome.
Detailed description
The product will contain an active ingredient- human allogeneic adipose-derived mesenchymal stem cells (ADSC) cells suspended in the fibrin solution applied directly onto prepared wound bed, to form thin gel layer on the wound surface.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allogeneic ADSC cells in fibrin solution | Experimental | Biological: Application of allogeneic ADSC stem cells in fibrin gelApplication of allogeneic ADSC stem cells in fibrin gel, to cover wound surface with thin cells layer. Therapy is based on standard procedure of diabetic foot ulcer treatment combined with application of allogeneic ADSC stem cells in fibrin solution onto the wound surface. |
| Standard care in diabetic foot ulcer with aplication of fibrin gel to cover wound surface. | Active comparator | Procedure: Standard care in diabetic foot ulcerApplication of fibrin gel to cover wound surface. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signing informed consent form.
- Above the age of 18
- Voluntary participation in the research, following the requirements of the protocol and acceptance for procedures related with its implementation
- Chronic wound in the course of diabetic foot syndrome, with the wound surface between 1 - 25 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study
- Blood level of glycated haemoglobin (HbA1c) <=11%
Key exclusion criteria (8 listed)
- Lack of patient's cooperation
- Wound etiology other than diabetic foot syndrome
- Clinicaly significant limb ischemia as verified by the measurement of the oxygen level in the foot tissue (<30 mmHg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (<50 mmHg)
- Active wound infection, which would require the treatment with antibiotics
- Known allergy to ingredients of study product (thrombin, penicillin).
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 |
|---|---|---|
| Application of allogeneic ADSC stem cells in fibrin gelChronic wounds in diabetic foot ulcer will be covered with ADSC suspended in fibrin gel - single dose will be administered followed by weekly wound control. | Biological | Allogeneic ADSC cells in fibrin solution |
| Standard care in diabetic foot ulcerChronic wounds in diabetic foot ulcer will be covered with fibrin gel followed by weekly wound control. | Procedure or surgery | Standard care in diabetic foot ulcer with aplication of fibrin gel to cover wound surface. |
Primary outcome
Changes in wound size
Time frame: 8 weeks
The comparison of the time required for the 50% reduction of initial wound size between patients in both study arms. The wound size changes will be assessed using digital 3D wound imaging medical device with image processing software, according to the following rules: * for wounds deeper than 0.5 cm - measurement of wound volume, or * for shallow wounds (less than 0.5 cm depth) - measurement of wound surface.
5 secondary outcomes
Changes in wound morphology
Time frame: 8 weeks
Changes in pro-angiogenic factors expression
Time frame: 8 weeks
Changes in wound-associated pain
Time frame: 8 weeks
Changes in the quality of life
Time frame: 8 weeks
Record of adverse events
Time frame: 8 weeks
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 14 Oct 2021.
Related trials for Diabetic Foot Ulcer
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Beata Mrozikiewicz-Rakowska, . Assoc.Prof. principal investigator
Medical University of Warsaw, Department of Diabetology and Internal Diseases
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 Application of allogeneic ADSC stem cells in fibrin gel in people with Diabetic Foot Ulcer, run by Medical University of Warsaw at 1 site in Poland.
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 7 inclusion and 8 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 14 Oct 2021. 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 Poland. 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?
Changes in wound size (time frame: 8 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 14 Oct 2021.