Study Stopped
Business decision with all subjects completing at least 1 year follow-up
Efficacy and Safety of Intramuscular PDA-002 in Subjects Who Have Diabetic Foot Ulcer With and Without Peripheral Arterial Disease
A Phase 2 Multicenter, Randomized, Doubleblind, Placebo-Controlled, Dose Range Finding Study to Evaluate the Efficacy and Safety of Intramuscular Injection of Human Placenta-derived Cells (Pda-002) in Subjects Who Have Diabetic Foot Ulcer With Peripheral Arterial Disease
1 other identifier
interventional
159
1 country
55
Brief Summary
The PDA-002-DFU-002 trial is a Phase 2, multicenter, randomized, double blind, placebo controlled, dose range finding study. The study will enroll approximately 133 subjects in four treatment groups. The primary objective of the study is to assess the efficacy and safety of PDA-002 administered intramuscular (IM) in subjects who have DFU with and without PAD. The secondary objective is to explore potential clinical efficacy by assessing changes in vascular parameters such as Ankle-Brachial Index and Toe-Brachial Index (ABI and/or TBI), Transcutaneous oxygen measurements (TcPO2).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2014
Typical duration for phase_2
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2014
CompletedFirst Posted
Study publicly available on registry
October 15, 2014
CompletedStudy Start
First participant enrolled
October 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2018
CompletedJuly 22, 2020
February 1, 2019
3.4 years
October 2, 2014
July 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Up to 4 months
Safety (adverse events [type, frequency, and severity of AEs, and relationship of AEs to study drug], laboratory abnormalities, and hospitalizations
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study.
Up to 24 months
Secondary Outcomes (13)
Time to ulcer closure
Up to 6 months
Ankle Brachial Index (ABI ) and Toe-Brachial Index (TBI)
Up to 6 months
50% Closure of Index Ulcer
Up to 24 months
Transcutaneous oxygen
Up to 6 months
Time to amputation, ulcer opening closing, gangrene and infection
Up to 24 months
- +8 more secondary outcomes
Study Arms (4)
3 x 10^6 cells
EXPERIMENTALHuman Placenta Derived cells (PDA-002) administered intramuscularly (IM) on Study Days 1 and 8
10 x 10^6 cells
EXPERIMENTAL10 x 10\^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8
30 x 10^6 cells
EXPERIMENTAL30 x 10\^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8
Placebo
PLACEBO COMPARATORIdentically matching placebo administered IM on Study Days 1 and 8
Interventions
3 x 10\^6 cells administered on Study Days 1 and 8
10 x 10\^6 Human Placenta Derived cells (PDA-002) administered on Study Days 1 and 8
30 x 10\^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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).
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
Cardiology PC
Birmingham, Alabama, 35211, United States
TFi Medical
Mobile, Alabama, 36608, United States
East Valley Foot and Ankle Specialist
Mesa, Arizona, 85206, United States
Carl T. Hayden Veterans Affairs Medical Center
Phoenix, Arizona, 85012, United States
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, 85023, United States
Aung Foothealth Clinics and Advanced Wound Care Center
Tucson, Arizona, 85710, United States
Northeast Arkansas Baptist Clinic
Jonesboro, Arkansas, 72401, United States
Jeffrey A Klemes DPM
Beverly Hills, California, 90211, United States
Center for Clinical Research Inc.
Castro Valley, California, 94546-5306, United States
Reliance Clinical Research
Chino, California, 91710, United States
Limb Preservation Platform, INC.
Fresno, California, 93720, United States
Foot and Ankle Clinic
Los Angeles, California, 90010, United States
UCLA
Los Angeles, California, 90095, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
Stanford University
Stanford, California, 94035-5821, United States
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, 20007-2197, United States
Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida, 33765, United States
Barry University
Fort Lauderdale, Florida, 33321, United States
Florida Research Network, LLC
Gainesville, Florida, 32605, United States
The Research Center
Hialeah, Florida, 33012, United States
University of Florida
Jacksonville, Florida, 32209, United States
Solutions Through Advanced Research Inc.
Jacksonville, Florida, 32258, United States
University of Miami
Miami, Florida, 33136, United States
Well Pharma Medical Research Corporation
Miami, Florida, 33143, United States
GF Professional Research Group Corporation
Miami Lakes, Florida, 33016, United States
Med-Care Research Inc
North Miami Beach, Florida, 33162, United States
Podiatry 1st
Belleville, Illinois, 62226, United States
University of Illinois at Chicago Cancer Center
Chicago, Illinois, 60612, United States
Weill Foot & Ankle Institute
Des Plaines, Illinois, 60016, United States
Rosalind Franklin University of Medicine and Science
North Chicago, Illinois, 60064, United States
Southern Illinois University
Springfield, Illinois, 62702, United States
Foot and Ankle Center of Illinois
Springfield, Illinois, 62704, United States
CGH Medical Center Main Clinic
Sterling, Illinois, 61081, United States
Hamilton Foot Care
Baltimore, Maryland, 21214, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Northwest Hospital
Randallstown, Maryland, 21133, United States
Revive Research Institute
Sterling Heights, Michigan, 48313, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
Office of Michael J. De Marco, DPM
Tinton Falls, New Jersey, 07724, United States
Ocean City Foot and Ankle Assoc
Toms River, New Jersey, 08753, United States
Animas Foot and Ankle
Gallup, New Mexico, 87301, United States
Office of Gerard J. Furst, DPM, PLLC
East Setauket, New York, 11733, United States
Syracuse VA Medical Center
Syracuse, New York, 13210, United States
UNC Hospitals University of North Carolina
Chapel Hill, North Carolina, 27599-7010, United States
Clinical Research Associates of Central Pennsylvania
Duncansville, Pennsylvania, 16635, United States
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, 19104, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9068, United States
Premier Vein and Vascular Center
Houston, Texas, 77084, United States
Complete Family Foot Care - McAllen Office
McAllen, Texas, 78501-2930, United States
Endeavor Clinical Trials PA
San Antonio, Texas, 78229, United States
SAM Clinical Research Center
San Antonio, Texas, 78229, United States
Advanced Foot & Ankle Center
Salt Lake City, Utah, 84102, United States
Carilion Clinic
Roanoke, Virginia, 24013, United States
1Foot 2Foot Centre for Foot & Ankle Care PC
Suffolk, Virginia, 23434, United States
Milwaukee Foot & Ankle Specialists
Wauwatosa, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Solveig Ericson, MD
Celularity Incorporated
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2014
First Posted
October 15, 2014
Study Start
October 23, 2014
Primary Completion
February 28, 2018
Study Completion
February 28, 2018
Last Updated
July 22, 2020
Record last verified: 2019-02