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Trial record 11 of 417 for:    Foot Diseases | "Diabetic Foot"

Safety, Hemodynamic Effects and Efficacy of Intramuscular PDA-002 in Subjects Who Have Diabetic Foot Ulcer With Peripheral Arterial Disease

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ClinicalTrials.gov Identifier: NCT02460081
Recruitment Status : Withdrawn (Discontinued due to significant delays in the expected availability of data.)
First Posted : June 2, 2015
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Celularity Incorporated

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Peripheral Arterial Disease Drug: PDA-002 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose Range Finding Study to Evaluate the Safety, Hemodynamic Effects and Efficacy of Intramuscular Injection of Human Placenta-derived Cells (Pda-002) in Subjects Who Have Diabetic Foot Ulcer With Peripheral Arterial Disease
Study Start Date : June 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PDA-002 -3x10^6 cells
Subjects will be treated with Investigational Product (IP) administered intramuscular (IM) on Study Days 1, 29 and 57.
Drug: PDA-002
Experimental: PDA-002 - 30X10^6 cells
Subjects will be treated with IP administered IM on Study Days 1, 29 and 57.
Drug: PDA-002
Placebo Comparator: Placebo
Subjects will be treated with Placebo administered IM on Study Days 1, 29 and 57.
Drug: Placebo



Primary Outcome Measures :
  1. 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.

  2. Transcutaneous oxygen measurement (TCOM) [ Time Frame: Approximately 1 year ]
    Transcutaneous oxygen measurement measures the oxygen flow in vessels beneath the skin surface


Secondary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: Approximatly 1 year ]
    Number of participants with adverse events

  2. Ulcer closure [ Time Frame: Approximatly 1 year ]
    Ulcer closure is defined as skin closure of the index ulcer without drainage or need for dressing.

  3. Complete wound closure of the index ulcer [ Time Frame: Approximatly 1 year ]
    Complete wound closure is defined as closure of the index ulcer and retaining wound closure for the subsequent 4 weeks.

  4. Number of ulcers [ Time Frame: Approximatly 1 year ]
    The total number of non index ulcers will be collected

  5. Size of ulcers [ Time Frame: Approximatly 1 year ]
    The area of each ulcer will be collected.

  6. 50% closure of the index ulcer [ Time Frame: Approximatly 1 year ]
    The time to when the ulcer has closed 50 % will be collected.

  7. Time to major amputation (above the ankle) of treated leg [ Time Frame: Approximatly 1 year ]
    The time to a major amputation (above the ankle) will be collected.

  8. Wagner Grading Scale [ Time Frame: Approximatly 1 year ]
    The extent of the ulcer will be collected using a standard scale for ulcer assessment.

  9. Rutherford Criteria [ Time Frame: Approximately 1 year ]
    The extent of symptoms associated with decreased limb perfusion will be collected using a standard scale.

  10. Leg Rest Pain Score Visual Analog Scale (VAS) [ Time Frame: Approximately 1 year ]
    Pre and Post treatment Limb Pain level will be assessed using a VAS

  11. Patient Global Impression of Change in Neuropathy (PGICN) [ Time Frame: Approximately 1 year ]
    Subjects will be assessed for symptoms of diabetic neuropathy using a standard scale.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females, at least 18 years of age or older at the time of signing the informed consent document.
  2. Diabetes mellitus Type 1 or Type 2.
  3. 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.
  4. Subjects who meet one or more of the following criteria of arterial insufficiency in the foot with the index ulcer:

    1. Peripheral arterial disease with ABI ≥ 0.40 and ≤ 0.80 or TBI ≥0.30 and ≤ 0.65.
    2. Transcutaneous oxygen measurement between 20 to 40 mmHg.
  5. No planned revascularization or amputation over the next 3 months after screening visit, in the opinion of the investigator.
  6. Dosing should not begin until at least 14 days after a failed reperfusion intervention and at least 30 days after a successful reperfusion intervention

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Pregnant or lactating females.
  4. Subjects with a body mass index > 40 mg/m2 at Screening.
  5. 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.
  6. 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).
  7. Known osteomyelitis or infection or cellulitis at or adjacent to the index ulcer.
  8. Limb pain at rest due to limb ischemia.
  9. 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).
  10. Poorly controlled diabetes mellitus (hemoglobin A1c >12% or a screening serum glucose of ≥ 300 mg/dL).
  11. Untreated proliferative retinopathy.
  12. 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.
  13. Abnormal ECG: new right bundle branch block (BBB) ≥ 120 msec in the preceding 3 months prior to signing the ICF.
  14. Uncontrolled hypercoagulation syndrome.
  15. Life expectancy less than 2 years due to concomitant illnesses.
  16. In the opinion of the investigator, the subject is unsuitable for cellular therapy.
  17. 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.
  18. History of hypersensitivity to any of the components of the product formulation (including bovine or porcine products, dextran 40, and dimethyl sulfoxide [DMSO]).
  19. 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.
  20. Subject has received previous investigational gene or cell therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460081


Locations
United States, Pennsylvania
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Celularity Incorporated
Investigators
Study Director: Monica E Luchi, MD Celularity Incorporated

Responsible Party: Celularity Incorporated
ClinicalTrials.gov Identifier: NCT02460081     History of Changes
Other Study ID Numbers: CCT-PDA-002-DFU-003
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: April 2016

Keywords provided by Celularity Incorporated:
PDA-002
Diabetic Foot Ulcer
Peripheral arterial disease
Phase 2
Randomized

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Skin Diseases
Endocrine System Diseases
Foot Diseases
Arterial Occlusive Diseases
Diabetic Angiopathies
Leg Ulcer
Skin Ulcer
Diabetes Complications
Diabetes Mellitus
Diabetic Neuropathies
Atherosclerosis
Arteriosclerosis