Hemodynamic Effects of Intramuscular PDA-002 in Subjects Who Have Diabetic Foot Ulcer With Periph… (NCT02460081) | Clinical Trial Compass
WithdrawnPhase 2
Hemodynamic Effects of Intramuscular PDA-002 in Subjects Who Have Diabetic Foot Ulcer With Peripheral Arterial Disease
Stopped: The study was withdrawn prior to enrollment. Four subjects were screened but did not meet eligibility criteria; therefore, no subjects were enrolled. The study was not pursued further for administrative reasons.
United States0Started 2015-06
Plain-language 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.
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.
. 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.
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.
. 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
Exclusion criteria
. 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.