Diabetic Foot UlcerPhase 2FOOTCELLNCT06843122
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
A Phase 2 study testing Allogeneic ADSC/ASC (alloADSC-DFU-RL) in people with Diabetic Foot Ulcer, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The goal of this study is to evaluate the safety and efficacy of an advanced therapy medicinal product containing live allogeneic adipose-derived mesenchymal stem cells (ADSC/ASC) for the treatment of diabetic foot ulcers in a randomized, double-blind, three-arm study. 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?
- Allogeneic ADSC/ASC (alloADSC-DFU-RL)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 sitePoland
- Study dates
- 5 Mar 2025to 1 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years at the time of consent
- The patient's psychophysical and legal ability to give informed consent to participate in the study,
- Signing the informed consent document for participation in the study,
- A confirmed diagnosis of type 1 diabetes, type 2 diabetes, LADA, MODY, or other types of diabetes, documented in accordance with current diagnostic criteria.
- Ulcer classified as diabetic foot syndrome (DFS) of neuropathic and/or neuroischemic etiology corresponding to grade IA/IIA and IC/IIC according to the University of Texas classification (Appendix E),
- A period of not less than 6 weeks since the onset of the ulceration,
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- Presence of a wound of 1-25 cm2 (after wound debridement),
- Satisfactory blood supply to the wound area (assessed by transcutaneous measurement of oxygen partial pressure, if not less than 30 mmHg, or measurement of systolic arterial pressure on the posterior tibial and/or dorsal artery of the foot, which will not be less than 50 mmHg) to exclude patients who require revascularisation therapy
- A glycated haemoglobin value (HbA1c) of no more than 11%,
- General health status of the patient that, in the opinion of the investigator, allows participation in all study procedures,
- Use of a form of wound relief recommended by the Investigator,
- In the case of women of childbearing potential, agreement to use of methods of effective contraception to avoid pregnancy and/or based on the following criteria: - a woman who is incapable of having offspring (after hysterectomy or bilateral ovarian resection or after menopause, defined as a period of at least 12 months since the last menstrual period) is exempt from pregnancy testing - a woman capable of having offspring with a negative pregnancy test result prior to the first day dose of the study product and who agrees to cycle pregnancy tests according to the study protocol and to use appropriate contraception until one month after the end of the active phase of the study (up to V6), or 2 months after the last administration of the study drug. For men - fertile men who are sexually active with a partner who may become pregnant are required to use a barrier method throughout the entire duration of the study, and the partners of study participants (who are capable of bearing children) are required to use the same contraceptive methods as female study participants until Visit V6.
Who cannot join
- Etiology of the ulcer other than diabetic foot syndrome,
- Presence of active infection in the wound at the time of inclusion in the study,
- Wound area <1 cm² or >25 cm²,
- Patient was eligible to participate in another clinical trial in the 4 weeks preceding study eligibility.
- Clinically significant limb ischaemia (assessed by transcutaneous measurement of oxygen partial pressure if less than 30 mmHg or measurement of systolic arterial pressure on the posterior tibial and dorsal artery of the foot which is less than 50 mmHg)
- Presence of an active phase of Charcot joint,
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- Osteitis and/or osteomyelitis, including cases assessed using a positive probe-to-bone test,
- Revascularisation procedure in the affected lower limb within less than 3 months prior to study inclusion or planned revascularisation procedure,
- Chronic kidney disease with GFR < 20 ml/min,
- Pregnancy and lactation,
- Allergy to thrombin,
- Active venous thrombosis,
- Systemic diseases in the exacerbation stage (acute or decompensated), including heart, kidney, and liver diseases,
- Active alcoholic disease or psychoactive drug addiction,
- Allergies to dressing materials used in the study,
- Oral/intravenous antibiotic therapy at the time of inclusion in the study,
- A patient undergoing immunosuppressive therapy, including systemic corticosteroid therapy (within 30 days prior to study inclusion). Topical corticosteroid therapy does not constitute an exclusion criterion.
- Patients undergoing immunotherapy for allergic diseases (within 30 days prior to the screening visit -calculated from the last dose of such therapy) or those planning to initiate or resume such therapy during the clinical trial,
- Active cancerous process or cancer in the last 5 years, excluding locally malignant tumors that do not involve the tissues of the foot
- Presence of a clinically known active, uncontrolled infection, e.g., Hepatitis B, Hepatitis C, HIV, and venereal disease (syphilis),
- Significant features of malnutrition further impairing the healing process, regardless of the cause (albumin < 2.5 g/dL and total protein < 5g/dL),
- Hemoglobin concentration < 9g/dL,
- Serum transaminase activity (alanine and aspartate) exceeding 3x the upper limit of normal (local) .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Szpital Bielanski Im.Ks.Jerzego Popieluszki Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Warsaw, 01-809
Beata Mrozikiewicz-Rakowska, Assoc.Prof., +48228343131, klinendo@bielanski.med.pl
About this study
Official title: Evaluation of the Safety and Efficacy of an Advanced Therapy Medicinal Product Containing Live ASCs in the Treatment of Diabetic Foot Syndrome - a Double-blind, Randomized Study.
The goal of this study is to evaluate the safety and efficacy of an advanced therapy medicinal product containing live allogeneic adipose-derived mesenchymal stem cells (ADSC/ASC) for the treatment of diabetic foot ulcers in a randomized, double-blind, three-arm study.
Read the detailed description
Patients will be randomized and assigned to one of three study groups and will receive the following study treatments: 1) two doses of cell solution; 2) one dose of cell solution and one dose of placebo solution; or 3) two doses of placebo solution. During the study, patients will attend weekly visits for routine monitoring and standard-of-care (SOC) treatment. The IMP or placebo will be administered two weeks apart, on days 0 and 14. Control visits are scheduled on days 7, 21, 28, 35, and 42, for a total of seven visits during the active phase of the study. Follow-up visits will be conducted 8, 26, and 52 weeks after the last visit of the active phase (day 42).
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Allogeneic ADSC/ASC (alloADSC-DFU-RL), Placebo (PL-DFU-RL)
- Keywords
- 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.
Allogeneic ADSC/ASC (alloADSC-DFU-RL)Biological
Allogeneic ADSC/ASC suspended in Ringer's lactate and reconstructed with fibrin sealant for application to the wound surface.
Placebo (PL-DFU-RL)Biological
Ringer's lactate without ADSC/ASC, reconstructed with fibrin sealant for application to the wound surface.
| Study group | Role | What they receive |
|---|---|---|
| A - Two administrations of allogeneic ADSC/ASC | Experimental | Participants will receive two administrations of allogeneic ADSC/ASC, at V0 (Day 0) and V2 (Day 14), in addition to standard-of-care (SOC) treatment for diabetic foot ulcer. Receives: Biological: Allogeneic ADSC/ASC (alloADSC-DFU-RL) |
| B - One administration of allogeneic ADSC/ASC and one administration of placebo | Experimental | Participants will receive allogeneic ADSC/ASC at V0 (Day 0), followed by placebo at V2 (Day 14), in addition to standard-of-care (SOC) treatment for diabetic foot ulcer. Receives: Biological: Allogeneic ADSC/ASC (alloADSC-DFU-RL); Biological: Placebo (PL-DFU-RL) |
| C - Two administrations of placebo | Placebo comparator | Participants will receive two administrations of placebo, at V0 (Day 0) and V2 (Day 14), in addition to standard-of-care (SOC) treatment for diabetic foot ulcer. Receives: Biological: Placebo (PL-DFU-RL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wound size (%) at 6 weeks after first study treatment administration compared to baseline with the actual wound size measured by the independent assessor.
Percentage change in wound size, measured by an independent assessor using a standardized wound area measurement method. The calculation is based on the difference between the baseline wound size and the wound size at 6 weeks, expressed as a percentage of the baseline value.
Measured: 6 weeks after the first administration
Type, frequency and severity of adverse events (assessed according CTCAE v5.0); change from baseline of laboratory parameters and selected vital signs of the participants.
Adverse events will be assessed based on type, frequency, and severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Changes from baseline in laboratory parameters and selected vital signs will be evaluated using standardized clinical measurement methods.
Measured: 6 weeks after the first administration
Secondary outcomes (6)
Early efficacy of the allogenic ADSC/ASC defined as percentage of patients with significant clinical success defined as complete wound closure (100% epithelialization), or partial epithelialization of the wound (>50% epithelialization)
The percentage of patients achieving significant clinical success, defined as either complete wound closure (100% epithelialization) or partial epithelialization of the wound (>50%). Wound epithelialization will be assessed using standardized wound assessment criteria by an independent assessor.
Measured: 6 weeks after the first administration
Long-term efficacy of the allogenic ADSC/ASC defined as percentage of patients with significant clinical success defined as complete wound closure (100% epithelialization), or partial epithelialization of the wound (>50% epithelialization) over time.
The percentage of patients achieving significant clinical success, defined as either complete wound closure (100% epithelialization) or partial epithelialization of the wound (>50%), assessed over time. Wound epithelialization will be evaluated using standardized wound assessment criteria by an independent assessor at predefined time points.
Measured: Through study completion, an average of 1 year
The dynamics of wound healing defined as the time required for patients to reach the wound size reduction thresholds: 50% reduction of the wound; maximum reduction of the wound area (%); complete wound healing .
The time required for patients to achieve predefined wound size reduction thresholds, including 50% wound size reduction, maximum wound area reduction (percentage), and complete wound healing (100% epithelialization). Wound size will be measured using standardized wound assessment methods by an independent assessor at predefined time points.
Measured: 6 weeks after the first administration and through study completion, an average of 1 year
Absolute change in the wound-associated pain perception over time assessed by the patient using visual analogue scale.
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.
Measured: 6 weeks after the first administration and through study completion, an average of 1 year
Additional safety parameters such as wound infection requiring antibiotic treatment expressed as total number of patients, and number of antibiotic therapies per patient.
The total number of patients with wound infections requiring antibiotic treatment and the number of antibiotic therapy courses per patient. Infections will be assessed based on clinical criteria and standard medical guidelines.
Measured: 6 weeks after the first administration and through study completion, an average of 1 year .
Changes in quality of life parameters assessed by the dedicated QoL questionnaire.
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".
Measured: 6 weeks after the first administration and through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start5 Mar 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:1:1 ratio to one of three parallel treatment arms: (A) two administrations of ADSC/ASC; (B) one administration of ADSC/ASC followed by one administration of placebo; or (C) two administrations of placebo. All participants will receive standard-of-care (SOC) treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland, University of Lodz
- Responsible party
- Sponsor
- Investigators
- Beata Mrozikiewicz-Rakowska, Assoc.Prof., Principal investigator, Bielanski Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843122
- Sponsor's protocol ID
- FOOTCELL
- Other IDs
- 2024-518533-29-00
- Acronym
- FOOTCELL
- Status last verified
- Aug 2026
- First submitted
- 30 Dec 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of an Advanced Therapy Medicinal Product Containing Live ASCs in the Treatment of Diabetic Foot Syndrome - a Double-blind, Randomized Study.
- ClinicalTrials.gov ID
- NCT06843122
- Acronym / sponsor ID
- FOOTCELL / FOOTCELL
- Conditions
- Diabetic Foot Ulcer
- Keywords
- adipose-derived mesenchymal stem cells, chronic wounds, diabetes, foot ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland, University of Lodz
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 24 Feb 2025 (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 goal of this study is to evaluate the safety and efficacy of an advanced therapy medicinal product containing live allogeneic adipose-derived mesenchymal stem cells (ADSC/ASC) for the treatment of diabetic foot ulcers in a randomized, double-blind, three-arm study.
Detailed description
Patients will be randomized and assigned to one of three study groups and will receive the following study treatments: 1) two doses of cell solution; 2) one dose of cell solution and one dose of placebo solution; or 3) two doses of placebo solution. During the study, patients will attend weekly visits for routine monitoring and standard-of-care (SOC) treatment. The IMP or placebo will be administered two weeks apart, on days 0 and 14. Control visits are scheduled on days 7, 21, 28, 35, and 42, for a total of seven visits during the active phase of the study. Follow-up visits will be conducted 8, 26, and 52 weeks after the last visit of the active phase (day 42).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be randomized in a 1:1:1 ratio to one of three parallel treatment arms: (A) two administrations of ADSC/ASC; (B) one administration of ADSC/ASC followed by one administration of placebo; or (C) two administrations of placebo. All participants will receive standard-of-care (SOC) treatment.
| Arm | Type | Receives |
|---|---|---|
| A - Two administrations of allogeneic ADSC/ASC | Experimental | Biological: Allogeneic ADSC/ASC (alloADSC-DFU-RL)Participants will receive two administrations of allogeneic ADSC/ASC, at V0 (Day 0) and V2 (Day 14), in addition to standard-of-care (SOC) treatment for diabetic foot ulcer. |
| B - One administration of allogeneic ADSC/ASC and one administration of placebo | Experimental | Biological: Allogeneic ADSC/ASC (alloADSC-DFU-RL), Biological: Placebo (PL-DFU-RL)Participants will receive allogeneic ADSC/ASC at V0 (Day 0), followed by placebo at V2 (Day 14), in addition to standard-of-care (SOC) treatment for diabetic foot ulcer. |
| C - Two administrations of placebo | Placebo comparator | Biological: Placebo (PL-DFU-RL)Participants will receive two administrations of placebo, at V0 (Day 0) and V2 (Day 14), in addition to standard-of-care (SOC) treatment for diabetic foot ulcer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years at the time of consent
- The patient's psychophysical and legal ability to give informed consent to participate in the study,
- Signing the informed consent document for participation in the study,
- A confirmed diagnosis of type 1 diabetes, type 2 diabetes, LADA, MODY, or other types of diabetes, documented in accordance with current diagnostic criteria.
- Ulcer classified as diabetic foot syndrome (DFS) of neuropathic and/or neuroischemic etiology corresponding to grade IA/IIA and IC/IIC according to the University of Texas classification (Appendix E),
Key exclusion criteria (23 listed)
- Etiology of the ulcer other than diabetic foot syndrome,
- Presence of active infection in the wound at the time of inclusion in the study,
- Wound area <1 cm² or >25 cm²,
- Patient was eligible to participate in another clinical trial in the 4 weeks preceding study eligibility.
- Clinically significant limb ischaemia (assessed by transcutaneous measurement of oxygen partial pressure if less than 30 mmHg or measurement of systolic arterial pressure on the posterior tibial and dorsal artery of the foot which is less than 50 mmHg)
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 |
|---|---|---|
| Allogeneic ADSC/ASC (alloADSC-DFU-RL)Allogeneic ADSC/ASC suspended in Ringer's lactate and reconstructed with fibrin sealant for application to the wound surface. | Biological | A - Two administrations of allogeneic ADSC/ASC, B - One administration of allogeneic ADSC/ASC and one administration of placebo |
| Placebo (PL-DFU-RL)Ringer's lactate without ADSC/ASC, reconstructed with fibrin sealant for application to the wound surface. | Biological | B - One administration of allogeneic ADSC/ASC and one administration of placebo, C - Two administrations of placebo |
Primary outcome
Change in wound size (%) at 6 weeks after first study treatment administration compared to baseline with the actual wound size measured by the independent assessor.
Time frame: 6 weeks after the first administration
Percentage change in wound size, measured by an independent assessor using a standardized wound area measurement method. The calculation is based on the difference between the baseline wound size and the wound size at 6 weeks, expressed as a percentage of the baseline value.
Type, frequency and severity of adverse events (assessed according CTCAE v5.0); change from baseline of laboratory parameters and selected vital signs of the participants.
Time frame: 6 weeks after the first administration
Adverse events will be assessed based on type, frequency, and severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Changes from baseline in laboratory parameters and selected vital signs will be evaluated using standardized clinical measurement methods.
6 secondary outcomes
Early efficacy of the allogenic ADSC/ASC defined as percentage of patients with significant clinical success defined as complete wound closure (100% epithelialization), or partial epithelialization of the wound (>50% epithelialization)
Time frame: 6 weeks after the first administration
Long-term efficacy of the allogenic ADSC/ASC defined as percentage of patients with significant clinical success defined as complete wound closure (100% epithelialization), or partial epithelialization of the wound (>50% epithelialization) over time.
Time frame: Through study completion, an average of 1 year
The dynamics of wound healing defined as the time required for patients to reach the wound size reduction thresholds: 50% reduction of the wound; maximum reduction of the wound area (%); complete wound healing .
Time frame: 6 weeks after the first administration and through study completion, an average of 1 year
Absolute change in the wound-associated pain perception over time assessed by the patient using visual analogue scale.
Time frame: 6 weeks after the first administration and through study completion, an average of 1 year
Additional safety parameters such as wound infection requiring antibiotic treatment expressed as total number of patients, and number of antibiotic therapies per patient.
Time frame: 6 weeks after the first administration and through study completion, an average of 1 year .
Changes in quality of life parameters assessed by the dedicated QoL questionnaire.
Time frame: 6 weeks after the first administration and through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Beata Mrozikiewicz-Rakowska, Assoc.Prof. principal investigator
Bielanski Hospital
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 Allogeneic ADSC/ASC (alloADSC-DFU-RL) 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 12 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beata Mrozikiewicz-Rakowska, Assoc.Prof. (+48 225690529, klinendo@bielanski.med.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wound size (%) at 6 weeks after first study treatment administration compared to baseline with the actual wound size measured by the independent assessor. (time frame: 6 weeks after the first administration). 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 26 Oct 2026.