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Recruitment Status : Withdrawn (Discontinued due to significant delays in the expected availability of data.)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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: PDA-002 -3x10^6 cells
Subjects will be treated with Investigational Product (IP) administered intramuscular (IM) on Study Days 1, 29 and 57.
Experimental: PDA-002 - 30X10^6 cells
Subjects will be treated with IP administered IM on Study Days 1, 29 and 57.
Placebo Comparator: Placebo
Subjects will be treated with Placebo administered IM on Study Days 1, 29 and 57.
- 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
- Adverse Events (AEs) [ Time Frame: Approximatly 1 year ]Number of participants with adverse events
- Ulcer closure [ Time Frame: Approximatly 1 year ]Ulcer closure is defined as skin closure of the index ulcer without drainage or need for dressing.
- 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.
- Number of ulcers [ Time Frame: Approximatly 1 year ]The total number of non index ulcers will be collected
- Size of ulcers [ Time Frame: Approximatly 1 year ]The area of each ulcer will be collected.
- 50% closure of the index ulcer [ Time Frame: Approximatly 1 year ]The time to when the ulcer has closed 50 % will be collected.
- 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.
- Wagner Grading Scale [ Time Frame: Approximatly 1 year ]The extent of the ulcer will be collected using a standard scale for ulcer assessment.
- Rutherford Criteria [ Time Frame: Approximately 1 year ]The extent of symptoms associated with decreased limb perfusion will be collected using a standard scale.
- 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
- 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.
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
|United States, Pennsylvania|
|University of Pennsylvania Health Systems|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Director:||Monica E Luchi, MD||Celularity Incorporated|