Study of PDA-002 in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcers (NCT01859117) | Clinical Trial Compass
CompletedPhase 1
Study of PDA-002 in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcers
United States15 participantsStarted 2013-05-23
Plain-language summary
This Phase 1, multicenter, open-label, dose-escalation study evaluated the safety and tolerability of intramuscular administration of PDA-002 (human placenta-derived cells) in subjects with peripheral arterial disease (PAD) and diabetic foot ulcers (DFU).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males and females, 18 to 80 years of age 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 2
. Ischemic or neuro-ischemic 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.
. Peripheral arterial disease with ankle-brachial index \> 0.5 and ≤ 0.9 or toe-brachial index \> 0.35 and ≤ 0.7.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose Limiting Toxicity (DLTs)
Timeframe: Through Day 15 following initial dosing
. 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 2 weeks after a failed reperfusion intervention and at least 2 months after a successful mechanical intervention.
Exclusion criteria
. 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.
. Subjects whom, in the judgment of the Investigator, are at elevated risk for the development of a malignancy. This judgment may be based on family history, history of industrial exposures, smoking history or other cancer risk factors.
. Known to be positive for human immunodeficiency virus.
. Pregnant or lactating females.
. Subjects with a body mass index \> 40 at Screening.
. Aspartate transaminase (AST) or Alanine transaminase (ALT) \> 2.5 x the upper limit of normal (ULN) at Screening.