Diabetic FootPhase 2NCT02460081
Hemodynamic Effects of Intramuscular PDA-002 in Subjects Who Have Diabetic Foot Ulcer With Peripheral Arterial Disease
A Phase 2 study testing PDA-002 in people with Diabetic Foot and Peripheral Arterial Disease, run by Celularity Incorporated at 1 site in United States.
Trial summary
Study PDA-002-DFU-003 is a Phase 2, multicenter, randomized, double blind, placebo-controlled, dose range finding study in subjects who have diabetic foot ulcer (DFU) with peripheral arterial disease (PAD). The study will enroll approximately 24 subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Peripheral Arterial Disease
- 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 6 Jan 2016
- 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 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.
- 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 of greater than one month duration which has not adequately responded to conventional ulcer therapy.
- Subjects who meet one or more of the following criteria of arterial insufficiency in the foot with the index ulcer:
- Peripheral arterial disease with ABI ≥ 0.40 and ≤ 0.80 or TBI ≥0.30 and ≤ 0.65.
- Transcutaneous oxygen measurement between 20 to 40 mmHg.
- No planned revascularization or amputation over the next 3 months after screening visit, in the opinion of the investigator.
- Dosing should not begin until at least 14 days after a failed reperfusion intervention and at least 30 days after a successful reperfusion intervention
Who cannot join
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study, at the discretion of the investigator.
- 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, at the discretion of the investigator.
- Pregnant or lactating females.
- Subjects with a body mass index > 40 mg/m2 at Screening.
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 at Screening calculated using the Modification of Diet in Renal Disease Study equation or history of eGFR decline > 15 mL/min/1.73 m2 in the past year.
- Untreated chronic infection or treatment of any infection with systemic antibiotics,including the ulcer site. Subject must be antibiotic free within 1 week prior to dosing with Investigational Product (IP).
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- Known osteomyelitis or infection or cellulitis at or adjacent to the index ulcer.
- Limb 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 ≥ 300 mg/dL).
- Untreated proliferative retinopathy.
- History of malignant ventricular arrhythmia, Canadian Cardiovascular Society (CCS) Class III-IV angina pectoris, myocardial infarction/PCI (percutaneous coronary intervention)/CABG (coronary artery bypass graft) in the preceding 6 months prior to signing the Informed Consent (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 2 years 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
1 site in 1 country.
United States1 site
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase 2 Double-blind, Placebo-controlled Study to Evaluate Hemodynamic Effects of Intramuscular Injection of Human Placenta-derived Cells (Pda-002) in Subjects Who Have Diabetic Foot Ulcer With Peripheral Arterial Disease
Study PDA-002-DFU-003 is a Phase 2, multicenter, randomized, double blind, placebo-controlled, dose range finding study in subjects who have diabetic foot ulcer (DFU) with peripheral arterial disease (PAD). The study will enroll approximately 24 subjects. This study will investigate the hemodynamic effects, clinical efficacy, and safety of 3 monthly intramuscular (IM) injections of PDA-002 in subjects who have DFU with PAD.
Read the detailed description
Although the study protocol was developed, the study was withdrawn prior to enrollment. Four subjects were screened but did not meet eligibility criteria, and no participants were enrolled.
- Conditions
- Diabetic Foot, Peripheral Arterial Disease
- Being tested
- PDA-002, Placebo
- Keywords
- PDA-002, Diabetic Foot Ulcer, Peripheral arterial disease, Phase 2, Randomized
- Medical subject headings
- Diabetic Foot, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDA-002Drug
3 million dose of PDA-002
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| PDA-002 -3x10^6 cells | Experimental | Subjects will be treated with Investigational Product (IP) administered intramuscular (IM) on Study Days 1, 29 and 57. Receives: Drug: PDA-002 |
| PDA-002 - 30X10^6 cells | Experimental | Subjects will be treated with IP administered IM on Study Days 1, 29 and 57. Receives: Drug: PDA-002 |
| Placebo | Placebo comparator | Subjects will be treated with Placebo administered IM on Study Days 1, 29 and 57. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle-brachial Index (ABI)
The ankle brachial index is the ratio of the measurement of the blood pressure in the ankle and the arm.
Measured: Approximately 1 year
Transcutaneous oxygen measurement (TCOM)
Transcutaneous oxygen measurement measures the oxygen flow in vessels beneath the skin surface
Measured: Approximately 1 year
Secondary outcomes (11)
Adverse Events (AEs)
Number of participants with adverse events
Measured: Approximatly 1 year
Ulcer closure
Ulcer closure is defined as skin closure of the index ulcer without drainage or need for dressing.
Measured: Approximatly 1 year
Complete wound closure of the index ulcer
Complete wound closure is defined as closure of the index ulcer and retaining wound closure for the subsequent 4 weeks.
Measured: Approximatly 1 year
Number of ulcers
The total number of non index ulcers will be collected
Measured: Approximatly 1 year
Size of ulcers
The area of each ulcer will be collected.
Measured: Approximatly 1 year
50% closure of the index ulcer
The time to when the ulcer has closed 50 % will be collected.
Measured: Approximatly 1 year
Time to major amputation (above the ankle) of treated leg
The time to a major amputation (above the ankle) will be collected.
Measured: Approximatly 1 year
Wagner Grading Scale
The extent of the ulcer will be collected using a standard scale for ulcer assessment.
Measured: Approximatly 1 year
Rutherford Criteria
The extent of symptoms associated with decreased limb perfusion will be collected using a standard scale.
Measured: Approximately 1 year
Leg Rest Pain Score Visual Analog Scale (VAS)
Pre and Post treatment Limb Pain level will be assessed using a VAS
Measured: Approximately 1 year
Patient Global Impression of Change in Neuropathy (PGICN)
Subjects will be assessed for symptoms of diabetic neuropathy using a standard scale.
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completion6 Jan 2016
Why it stopped: The study was withdrawn prior to enrollment. Four subjects were screened but did not meet eligibility criteria; therefore, no subjects were enrolled. The study was not pursued further for administrative reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celularity Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- sharmila koppisetti, Study director, Celularity Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460081
- Sponsor's protocol ID
- CCT-PDA-002-DFU-003
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2015
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Double-blind, Placebo-controlled Study to Evaluate Hemodynamic Effects of Intramuscular Injection of Human Placenta-derived Cells (Pda-002) in Subjects Who Have Diabetic Foot Ulcer With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT02460081
- Acronym / sponsor ID
- CCT-PDA-002-DFU-003
- Conditions
- Diabetic Foot, Peripheral Arterial Disease
- Keywords
- PDA-002, Diabetic Foot Ulcer, Peripheral arterial disease, Phase 2, Randomized
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn prior to enrollment. Four subjects were screened but did not meet eligibility criteria; therefore, no subjects were enrolled. The study was not pursued further for administrative reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Celularity IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- 6 Jan 2016 (actual)
- First posted
- 2 Jun 2015 (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.
Study PDA-002-DFU-003 is a Phase 2, multicenter, randomized, double blind, placebo-controlled, dose range finding study in subjects who have diabetic foot ulcer (DFU) with peripheral arterial disease (PAD). The study will enroll approximately 24 subjects. This study will investigate the hemodynamic effects, clinical efficacy, and safety of 3 monthly intramuscular (IM) injections of PDA-002 in subjects who have DFU with PAD.
Detailed description
Although the study protocol was developed, the study was withdrawn prior to enrollment. Four subjects were screened but did not meet eligibility criteria, and no participants were enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PDA-002 -3x10^6 cells | Experimental | Drug: PDA-002Subjects will be treated with Investigational Product (IP) administered intramuscular (IM) on Study Days 1, 29 and 57. |
| PDA-002 - 30X10^6 cells | Experimental | Drug: PDA-002Subjects will be treated with IP administered IM on Study Days 1, 29 and 57. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will be treated with Placebo administered IM on Study Days 1, 29 and 57. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females, at least 18 years of age or older at the time of signing the informed consent document.
- 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 of greater than one month duration which has not adequately responded to conventional ulcer therapy.
- Subjects who meet one or more of the following criteria of arterial insufficiency in the foot with the index ulcer:
- No planned revascularization or amputation over the next 3 months after screening visit, in the opinion of the investigator.
Key exclusion criteria (20 listed)
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study, at the discretion of the investigator.
- 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, at the discretion of the investigator.
- Pregnant or lactating females.
- Subjects with a body mass index > 40 mg/m2 at Screening.
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 at Screening calculated using the Modification of Diet in Renal Disease Study equation or history of eGFR decline > 15 mL/min/1.73 m2 in the past year.
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-0023 million dose of PDA-002 | Drug | PDA-002 - 30X10^6 cells, PDA-002 -3x10^6 cells |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Ankle-brachial Index (ABI)
Time frame: Approximately 1 year
The ankle brachial index is the ratio of the measurement of the blood pressure in the ankle and the arm.
Transcutaneous oxygen measurement (TCOM)
Time frame: Approximately 1 year
Transcutaneous oxygen measurement measures the oxygen flow in vessels beneath the skin surface
11 secondary outcomes
Adverse Events (AEs)
Time frame: Approximatly 1 year
Ulcer closure
Time frame: Approximatly 1 year
Complete wound closure of the index ulcer
Time frame: Approximatly 1 year
Number of ulcers
Time frame: Approximatly 1 year
Size of ulcers
Time frame: Approximatly 1 year
50% closure of the index ulcer
Time frame: Approximatly 1 year
Time to major amputation (above the ankle) of treated leg
Time frame: Approximatly 1 year
Wagner Grading Scale
Time frame: Approximatly 1 year
Rutherford Criteria
Time frame: Approximately 1 year
Leg Rest Pain Score Visual Analog Scale (VAS)
Time frame: Approximately 1 year
Patient Global Impression of Change in Neuropathy (PGICN)
Time frame: Approximately 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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 study director
Celularity Incorporated
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 PDA-002 in people with Diabetic Foot and Peripheral Arterial Disease, run by Celularity Incorporated at 1 site 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 8 inclusion and 20 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: withdrawn, as of the sponsor's last update on 29 Apr 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Ankle-brachial Index (ABI) (time frame: Approximately 1 year). 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 29 Apr 2026.