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Stopped: The study was withdrawn prior to enrollment.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 range18 Years
SexALL
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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.
✓. 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
. 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.