Efficacy and Safety of Intramuscular PDA-002 in Subjects With Diabetic Foot Ulcer With and Withou… (NCT02264288) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety of Intramuscular PDA-002 in Subjects With Diabetic Foot Ulcer With and Without PAD.
Stopped: The study was terminated early due to a business decision.
United States159 participantsStarted 2014-10-23
Plain-language summary
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.
Who can participate
Age range
18 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, 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.
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
Percentage of Subjects With Complete Wound Closure of the Index Ulcer Within 3 Months
Timeframe: Within 3 months after dosing, with confirmation over the subsequent 4 weeks
. 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.
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.
. 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.