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

NCT02460081 | Withdrawn Phase 2 DMC

• 1 other identifier: CCT-PDA-002-DFU-003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Peripheral Arterial Disease

Keywords

PDA-002; Diabetic Foot Ulcer; Peripheral arterial disease; Phase 2; Randomized

Outcome Measures

Primary Outcomes (2)

• Ankle-brachial Index (ABI)

  The ankle brachial index is the ratio of the measurement of the blood pressure in the ankle and the arm.

  Approximately 1 year

• Transcutaneous oxygen measurement (TCOM)

  Transcutaneous oxygen measurement measures the oxygen flow in vessels beneath the skin surface

  Approximately 1 year

Secondary Outcomes (11)

• Adverse Events (AEs)

  Approximatly 1 year

• Ulcer closure

  Approximatly 1 year

• Complete wound closure of the index ulcer

  Approximatly 1 year

• Number of ulcers

  Approximatly 1 year

• Size of ulcers

  Approximatly 1 year

Study Arms (3)

PDA-002 -3x10^6 cells

EXPERIMENTAL

Subjects will be treated with Investigational Product (IP) administered intramuscular (IM) on Study Days 1, 29 and 57.

Drug: PDA-002

PDA-002 - 30X10^6 cells

EXPERIMENTAL

Subjects will be treated with IP administered IM on Study Days 1, 29 and 57.

Drug: PDA-002

Placebo

PLACEBO COMPARATOR

Subjects will be treated with Placebo administered IM on Study Days 1, 29 and 57.

Drug: Placebo

Interventions

PDA-002 DRUG

3 million dose of PDA-002

PDA-002 - 30X10^6 cells; PDA-002 -3x10^6 cells

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Celularity Incorporated: lead

Study Sites (1)

University of Pennsylvania Health Systems

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Study Officials

• sharmila koppisetti

  Celularity Incorporated

  STUDY DIRECTOR

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: April 21, 2015
• First Posted: June 2, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 6, 2016
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)