Efficacy and Safety of Intramuscular PDA-002 in Subjects With Diabetic Foot Ulcer With and Without PAD.
Public ClinicalTrials.gov record NCT02264288. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02264288
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 159 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 22, 2014
- Primary completion
- Feb 26, 2018
- Completion
- Feb 26, 2018
- Last update posted
- Jun 11, 2026
2014 – 2018
United States locations
- U.S. sites
- 45
- U.S. states
- 17
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cardiology PC | Birmingham | Alabama | 35211 | — |
| Swagel wootoon hiatt eye center | Mesa | Arizona | 85206 | — |
| Carl T. Hayden Veterans Affairs Medical Center | Phoenix | Arizona | 85012 | — |
| Arizona Arthritis and Rheumatology Research, PLLC | Phoenix | Arizona | 85023 | — |
| NEA baptist clinic | Jonesboro | Arkansas | 72401 | — |
| Jeffrey A Klemes DPM | Beverly Hills | California | 90211 | — |
| Reliance Clinical Research | Chino | California | 91710 | — |
| Limb Preservation Platform, INC. | Fresno | California | 93720 | — |
| Foot and Ankle Clinic | Los Angeles | California | 90057 | — |
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | — |
| Center for Clinical Research Inc. | San Francisco | California | 94115 | — |
| Stanford University | Stanford | California | 94063 | — |
| Animas Foot and Ankle | Durango | Colorado | 81301 | — |
| Georgetown University Medical Center Lombardi Cancer Center | Washington D.C. | District of Columbia | 20007-2197 | — |
| Clinical Research of West Florida Inc - Clearwater | Clearwater | Florida | 33765 | — |
| Florida Research Network, LLC | Gainesville | Florida | 32605 | — |
| The Research Center | Hialeah | Florida | 33012 | — |
| University of Florida | Jacksonville | Florida | 32209 | — |
| Solutions Through Advanced Research Inc. | Jacksonville | Florida | 32258 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Well Pharma Medical Research Corporation | Miami | Florida | 33143 | — |
| GF Professional Research Group Corporation | Miami Lakes | Florida | 33016 | — |
| Podiatry 1st | Belleville | Illinois | 62226 | — |
| Weill Foot & Ankle Institute | Des Plaines | Illinois | 60016 | — |
| Rosalind Franklin University of Medicine and Science | North Chicago | Illinois | 60064 | — |
| Foot and Ankle Center of Illinois | Springfield | Illinois | 62704 | — |
| CGH Medical Center Main Clinic | Sterling | Illinois | 61081 | — |
| Hamilton Foot Care | Baltimore | Maryland | 21214 | — |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | — |
| Northwest Hospital | Randallstown | Maryland | 21133 | — |
| Revive Research Institute | Sterling Heights | Michigan | 48313 | — |
| Englewood Hospital and Medical Center | Englewood | New Jersey | 07631 | — |
| Office of Michael J. De Marco, DPM | Newark | New Jersey | 07102 | — |
| Ocean City Foot and Ankle Assoc | Toms River | New Jersey | 08753 | — |
| UNC Hospitals University of North Carolina | Chapel Hill | North Carolina | 27599-7010 | — |
| Bert J Altmanshofer and associates, LTD | Duncansville | Pennsylvania | 16635 | — |
| University of Pennsylvania Health Systems | Philadelphia | Pennsylvania | 19104 | — |
| Premier Vein and Vascular Center | Houston | Texas | 77084 | — |
| Futuro Clinical trials | McAllen | Texas | 78501-2930 | — |
| Endeavor Clinical Trials PA | San Antonio | Texas | 78229 | — |
| SAM Clinical Research Center | San Antonio | Texas | 78229 | — |
| Advanced Foot & Ankle Center | Salt Lake City | Utah | 84102 | — |
| Carilion Clinic | Roanoke | Virginia | 24013 | — |
| 1Foot 2Foot Centre for Foot & Ankle Care PC | Suffolk | Virginia | 23434 | — |
| Milwaukee Foot & Ankle Specialists | Wauwatosa | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02264288, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 11, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02264288 live on ClinicalTrials.gov.