Peripheral Arterial DiseasePhase 2DFU-002NCT02264288
Efficacy and Safety of Intramuscular PDA-002 in Subjects With Diabetic Foot Ulcer With and Without PAD.
A Phase 2 study testing PDA-002 in people with Peripheral Arterial Disease and Diabetic Foot, run by Celularity Incorporated at 45 sites in United States.
Trial summary
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of intramuscular administration of human placenta-derived cells (PDA-002) in subjects with diabetic foot ulcers (DFU), including subjects with and without peripheral arterial disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Diabetic Foot
- What is being tested?
- PDA-002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 45 sitesUnited States
- Study dates
- 23 Oct 2014to 27 Feb 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males and females, at least 18 years of age or older at the time of signing the informed consent document.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
- Able to adhere to the study visit schedule and other protocol requirements.
- Diabetes mellitus Type 1 or Type 2.
- Diabetic foot ulcer with severity of Grade 1 (full thickness only) or Grade 2 on the Wagner Grading Scale (Appendix A) of greater than one month duration which has not adequately responded to conventional ulcer therapy with a size of at least of 1cm2 except if present on the toe. The maximum lesion size range in the index ulcer is ≤ 10cm2. The measurement of the index ulcer is to be evaluated and measured after debridement (if necessary) at the Screening Visit. If located on the plantar aspect of the foot, the index ulcer must be able to be adequately offloaded in the assessment of the investigator.
- No planned revascularization or amputation over the next 3 months after Screening visit, in the opinion of the Investigator.
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- Screening should not begin until at least 14 days after a failed reperfusion intervention and at least 30 days after a successful reperfusion intervention.
- Subjects should be receiving appropriate medical therapy for hypertension and diabetes any other chronic medical conditions for which they require ongoing care.
- A female of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to treatment with study therapy. In addition, sexually active FCBP must agree to use 2 of the following adequate forms of contraception methods simultaneously such as: oral, injectable, or implantable hormonal contraception; tubal ligation; IUD; barrier contraceptive with spermicide or vasectomized partner for the duration of the study and the Follow-up Period.
- Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP for the duration of the study and the Follow-up Period.
Who cannot join
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he or she were to participate in the study.
- Any condition that confounds the ability to interpret data from the study.
- Pregnant or lactating females.
- Subjects with a body mass index > 45 kg/m2 at Screening.
- AST (SGOT) or ALT (SGPT) > 2.5 x the upper limit of normal (ULN) at Screening.
Show all 26Show fewer
- Patient on renal dialysis for abnormal kidney function.
- An ABI < 0.4 and or TBI < 0.3 in the leg with the index ulcer.
- Bilirubin level > 2 mg/dL (unless subject has known Gilbert's disease) at Screening.
- Untreated chronic infection or treatment of any infection with systemic antibiotics, including the ulcer site, must be free of antibiotics within 1 week prior to dosing with IP.
- Active osteomyelitis, infection, or cellulites at or adjacent to the index ulcer. Patients with a history of being treated for an osteomyelitis without a surgical resection.
- Index ulcer that has decreased or increased in size by ≥ 30% during the Screening/Run-In/ Pre-Treatment Period.
- Active Charcot Neuroarthropathy in the foot with the index ulcer
- Pain at rest due to limb ischemia.
- Uncontrolled hypertension (defined as diastolic blood pressure > 100 mmHg or systolic blood pressure > 180 mmHg during Screening at 2 independent measurements taken while subject is sitting and resting for at least 5 minutes).
- Poorly controlled diabetes mellitus (hemoglobin A1c > 12% or a screening serum glucose of ≥ 300mg/dl).
- Untreated proliferative retinopathy.
- History of malignant ventricular arrhythmia, CCS Class III-IV angina pectoris, myocardial infarction/ percutaneous coronary intervention (PCI) / coronary artery bypass graft (CABG) in the preceding 6 months prior to signing the informed consent form (ICF), pending coronary revascularization in the following 3 months, transient ischemic attack/cerebrovascular accident in the preceding 6 months, prior to signing the ICF, and/or New York Heart Association [NYHA] Stage III or IV congestive heart failure.
- Abnormal ECG: new right bundle branch block (BBB) ≥ 120 msec in the preceding 3 months prior to signing the ICF.
- Uncontrolled hypercoagulation syndrome.
- Life expectancy less than at 2 years at the time of signing the ICF due to concomitant illnesses.
- In the opinion of the Investigator, the subject is unsuitable for cellular therapy.
- History of malignancy within 5 years prior to signing the ICF except basal cell or squamous cell carcinoma of the skin or remote history of cancer now considered cured or positive Pap smear with subsequent negative follow-up.
- History of hypersensitivity to any of the components of the product formulation (including bovine or porcine products, dextran 40, and dimethyl sulfoxide [DMSO]).
- Subject has received an investigational agent -an agent or device not approved by the US Food and Drug Administration (FDA) for marketed use in any indication- within 90 days (or 5 half-lives, whichever is longer) prior to treatment with study therapy or planned participation in another therapeutic study prior to the completion of this study.
- Subject has received previous investigational gene or cell therapy.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
Hamilton Foot Care
Baltimore, Maryland, 21214
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Podiatry 1st
Belleville, Illinois, 62226
Jeffrey A Klemes DPM
Beverly Hills, California, 90211
Cardiology PC
Birmingham, Alabama, 35211
UNC Hospitals University of North Carolina
Chapel Hill, North Carolina, 27599-7010
Reliance Clinical Research
Chino, California, 91710
Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida, 33765
Weill Foot & Ankle Institute
Des Plaines, Illinois, 60016
Bert J Altmanshofer and associates, LTD
Duncansville, Pennsylvania, 16635
Animas Foot and Ankle
Durango, Colorado, 81301
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
Limb Preservation Platform, INC.
Fresno, California, 93720
Florida Research Network, LLC
Gainesville, Florida, 32605
The Research Center
Hialeah, Florida, 33012
Premier Vein and Vascular Center
Houston, Texas, 77084
University of Florida
Jacksonville, Florida, 32209
Solutions Through Advanced Research Inc.
Jacksonville, Florida, 32258
NEA baptist clinic
Jonesboro, Arkansas, 72401
Foot and Ankle Clinic
Los Angeles, California, 90057
Futuro Clinical trials
McAllen, Texas, 78501-2930
Swagel wootoon hiatt eye center
Mesa, Arizona, 85206
University of Miami
Miami, Florida, 33136
Well Pharma Medical Research Corporation
Miami, Florida, 33143
GF Professional Research Group Corporation
Miami Lakes, Florida, 33016
Office of Michael J. De Marco, DPM
Newark, New Jersey, 07102
Rosalind Franklin University of Medicine and Science
North Chicago, Illinois, 60064
VA Palo Alto Health Care System
Palo Alto, California, 94304
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, 19104
Carl T. Hayden Veterans Affairs Medical Center
Phoenix, Arizona, 85012
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, 85023
Northwest Hospital
Randallstown, Maryland, 21133
Carilion Clinic
Roanoke, Virginia, 24013
Advanced Foot & Ankle Center
Salt Lake City, Utah, 84102
Endeavor Clinical Trials PA
San Antonio, Texas, 78229
SAM Clinical Research Center
San Antonio, Texas, 78229
Center for Clinical Research Inc.
San Francisco, California, 94115
Foot and Ankle Center of Illinois
Springfield, Illinois, 62704
Stanford University
Stanford, California, 94063
CGH Medical Center Main Clinic
Sterling, Illinois, 61081
Revive Research Institute
Sterling Heights, Michigan, 48313
1Foot 2Foot Centre for Foot & Ankle Care PC
Suffolk, Virginia, 23434
Ocean City Foot and Ankle Assoc
Toms River, New Jersey, 08753
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, 20007-2197
Milwaukee Foot & Ankle Specialists
Wauwatosa, Wisconsin, 53226
About this study
Official title: A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Range Finding Study to Evaluate the Efficacy and Safety of Intramuscular Injection of Human Placenta-Derived Cells (PDA-002) in Subjects With Diabetic Foot Ulcer With and Without Peripheral Arterial Disease.
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of intramuscular administration of human placenta-derived cells (PDA-002) in subjects with diabetic foot ulcers (DFU), including subjects with and without peripheral arterial disease (PAD). Subjects were randomized to receive one of three dose levels of PDA-002 or placebo. Randomization was stratified by PAD status. The study evaluated wound healing and safety outcomes over the follow-up period.
Read the detailed description
This Phase 2 study was designed to evaluate the efficacy and safety of PDA-002, a human placenta-derived cell therapy, administered via intramuscular injection in subjects with diabetic foot ulcers (DFU). The study included subjects with and without peripheral arterial disease (PAD), reflecting a broader DFU population.
Subjects were randomized in a parallel-group design to receive PDA-002 at one of three dose levels (3 × 10^6, 10 × 10^6, or 30 × 10^6 cells) or matching placebo, administered on Study Days 1 and 8. Randomization was stratified by PAD status.
The primary objective was to assess efficacy in terms of wound healing outcomes, with secondary objectives evaluating vascular parameters such as ankle-brachial index (ABI), toe-brachial index (TBI), and transcutaneous oxygen pressure (TcPO2), as well as overall safety.
The study was terminated early due to a business decision; however, subjects were followed according to protocol-defined follow-up schedules.
- Conditions
- Peripheral Arterial Disease, Diabetic Foot
- Being tested
- PDA-002, Placebo
- Keywords
- Peripheral Arterial Disease, Diabetic Foot, Placenta Derived Stem Cells
- Medical subject headings
- Peripheral Arterial Disease, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDA-002Biological
Human placenta-derived cells administered intramuscularly on Study Days 1 and 8 at assigned dose levels.
PlaceboOther
Matching placebo administered intramuscularly on Study Days 1 and 8.
| Study group | Role | What they receive |
|---|---|---|
| PDA-002 3 x 10^6 cells | Experimental | Subjects randomized to receive PDA-002 at a dose of 3 × 10^6 cells administered intramuscularly on Study Days 1 and 8. Randomization was stratified by peripheral arterial disease (PAD) status (subjects with PAD and subjects without PAD). Receives: Biological: PDA-002 |
| PDA-002 10 x 10^6 cells | Experimental | Subjects randomized to receive PDA-002 at a dose of 10 × 10^6 cells administered intramuscularly on Study Days 1 and 8. Randomization was stratified by peripheral arterial disease (PAD) status (subjects with PAD and subjects without PAD). Receives: Biological: PDA-002 |
| PDA-002 30 x 10^6 cells | Experimental | Subjects randomized to receive PDA-002 at a dose of 30 × 10^6 cells administered intramuscularly on Study Days 1 and 8. Randomization was stratified by peripheral arterial disease (PAD) status (subjects with PAD and subjects without PAD). Receives: Biological: PDA-002 |
| Placebo | Placebo comparator | Subjects randomized to receive matching placebo administered intramuscularly on Study Days 1 and 8. Randomization was stratified by peripheral arterial disease (PAD) status. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Complete Wound Closure of the Index Ulcer Within 3 Months
Complete wound closure is defined as closure of the index ulcer within 3 months after dosing and retaining wound closure for the subsequent 4 weeks.
Measured: Within 3 months after dosing, with confirmation over the subsequent 4 weeks
Secondary outcomes (2)
Percentage of Subjects With Complete Wound Closure of the Index Ulcer Within 3 Months by PAD Status
Results are presented by baseline peripheral arterial disease (PAD) status (subjects with PAD and subjects without PAD). Complete wound closure is defined as closure of the index ulcer and retaining wound closure for the subsequent 4 weeks.
Measured: Within 3 months after dosing, with confirmation over the subsequent 4 weeks
Percentage of Subjects With Improvement in Rutherford Classification at Month 3 in Subjects With PAD
Responders are defined as subjects who improved by at least 1 numeric Rutherford category from baseline. Results are reported for subjects with peripheral arterial disease (PAD).
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study start23 Oct 2014
- Primary completion27 Feb 2018
- Study completion27 Feb 2018
Why it stopped: The study was terminated early due to a business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celularity Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharmila Koppisetti, MD, Study director, Celularity Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264288
- Sponsor's protocol ID
- CCT-PDA-002-DFU-002
- Acronym
- DFU-002
- Status last verified
- May 2026
- First submitted
- 2 Oct 2014
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pollak R, Anderson J, Altmanshofer B, Caporusso J, Fantini G, Koppisetti S, Brigido S, Hariri R. Human Placenta-Derived Cells (PDA-002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi-Center, Randomised, Double-Blind, Placebo-Controlled Trial. Int Wound J. 2025 Oct;22(10):e70769. doi: 10.1111/iwj.70769.
PubMed 41077558
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Range Finding Study to Evaluate the Efficacy and Safety of Intramuscular Injection of Human Placenta-Derived Cells (PDA-002) in Subjects With Diabetic Foot Ulcer With and Without Peripheral Arterial Disease.
- ClinicalTrials.gov ID
- NCT02264288
- Acronym / sponsor ID
- DFU-002 / CCT-PDA-002-DFU-002
- Conditions
- Peripheral Arterial Disease, Diabetic Foot
- Keywords
- Peripheral Arterial Disease, Diabetic Foot, Placenta Derived Stem Cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to a business decision.
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Celularity IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2014 (actual)
- Primary completion
- 27 Feb 2018 (actual)
- Study completion
- 27 Feb 2018 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Posted 12 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of intramuscular administration of human placenta-derived cells (PDA-002) in subjects with diabetic foot ulcers (DFU), including subjects with and without peripheral arterial disease (PAD). Subjects were randomized to receive one of three dose levels of PDA-002 or placebo. Randomization was stratified by PAD status. The study evaluated wound healing and safety outcomes over the follow-up period.
Detailed description
This Phase 2 study was designed to evaluate the efficacy and safety of PDA-002, a human placenta-derived cell therapy, administered via intramuscular injection in subjects with diabetic foot ulcers (DFU). The study included subjects with and without peripheral arterial disease (PAD), reflecting a broader DFU population.
Subjects were randomized in a parallel-group design to receive PDA-002 at one of three dose levels (3 × 10^6, 10 × 10^6, or 30 × 10^6 cells) or matching placebo, administered on Study Days 1 and 8. Randomization was stratified by PAD status.
The primary objective was to assess efficacy in terms of wound healing outcomes, with secondary objectives evaluating vascular parameters such as ankle-brachial index (ABI), toe-brachial index (TBI), and transcutaneous oxygen pressure (TcPO2), as well as overall safety.
The study was terminated early due to a business decision; however, subjects were followed according to protocol-defined follow-up schedules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PDA-002 3 x 10^6 cells | Experimental | Biological: PDA-002Subjects randomized to receive PDA-002 at a dose of 3 × 10^6 cells administered intramuscularly on Study Days 1 and 8. Randomization was stratified by peripheral arterial disease (PAD) status (subjects with PAD and subjects without PAD). |
| PDA-002 10 x 10^6 cells | Experimental | Biological: PDA-002Subjects randomized to receive PDA-002 at a dose of 10 × 10^6 cells administered intramuscularly on Study Days 1 and 8. Randomization was stratified by peripheral arterial disease (PAD) status (subjects with PAD and subjects without PAD). |
| PDA-002 30 x 10^6 cells | Experimental | Biological: PDA-002Subjects randomized to receive PDA-002 at a dose of 30 × 10^6 cells administered intramuscularly on Study Days 1 and 8. Randomization was stratified by peripheral arterial disease (PAD) status (subjects with PAD and subjects without PAD). |
| Placebo | Placebo comparator | Other: PlaceboSubjects randomized to receive matching placebo administered intramuscularly on Study Days 1 and 8. Randomization was stratified by peripheral arterial disease (PAD) status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females, at least 18 years of age or older at the time of signing the informed consent document.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
- Able to adhere to the study visit schedule and other protocol requirements.
- Diabetes mellitus Type 1 or Type 2.
- Diabetic foot ulcer with severity of Grade 1 (full thickness only) or Grade 2 on the Wagner Grading Scale (Appendix A) of greater than one month duration which has not adequately responded to conventional ulcer therapy with a size of at least of 1cm2 except if present on the toe. The maximum lesion size range in the index ulcer is ≤ 10cm2. The measurement of the index ulcer is to be evaluated and measured after debridement (if necessary) at the Screening Visit. If located on the plantar aspect of the foot, the index ulcer must be able to be adequately offloaded in the assessment of the investigator.
Key exclusion criteria (26 listed)
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he or she were to participate in the study.
- Any condition that confounds the ability to interpret data from the study.
- Pregnant or lactating females.
- Subjects with a body mass index > 45 kg/m2 at Screening.
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 |
|---|---|---|
| PDA-002Human placenta-derived cells administered intramuscularly on Study Days 1 and 8 at assigned dose levels. | Biological | PDA-002 10 x 10^6 cells, PDA-002 3 x 10^6 cells, PDA-002 30 x 10^6 cells |
| PlaceboMatching placebo administered intramuscularly on Study Days 1 and 8. | Other | Placebo |
Primary outcome
Percentage of Subjects With Complete Wound Closure of the Index Ulcer Within 3 Months
Time frame: Within 3 months after dosing, with confirmation over the subsequent 4 weeks
Complete wound closure is defined as closure of the index ulcer within 3 months after dosing and retaining wound closure for the subsequent 4 weeks.
2 secondary outcomes
Percentage of Subjects With Complete Wound Closure of the Index Ulcer Within 3 Months by PAD Status
Time frame: Within 3 months after dosing, with confirmation over the subsequent 4 weeks
Percentage of Subjects With Improvement in Rutherford Classification at Month 3 in Subjects With PAD
Time frame: Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41077558Pollak R, Anderson J, Altmanshofer B, Caporusso J, Fantini G, Koppisetti S, Brigido S, Hariri R. Human Placenta-Derived Cells (PDA-002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi-Center, Randomised, Double-Blind, Placebo-Controlled Trial. Int Wound J. 2025 Oct;22(10):e70769. doi: 10.1111/iwj.70769.
- Individual participant dataSharing planned: No
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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.
Sharmila Koppisetti, MD study director
Celularity Incorporated
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PDA-002 in people with Peripheral Arterial Disease and Diabetic Foot, run by Celularity Incorporated at 45 sites in United States.
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 10 inclusion and 26 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: stopped early, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. 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?
Yes. Results are posted in the registry (first posted 12 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects With Complete Wound Closure of the Index Ulcer Within 3 Months (time frame: Within 3 months after dosing, with confirmation over the subsequent 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02264288, which also lists 1 linked publication.
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 Jun 2026.