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

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.

Timeline

Start

2015-06

Primary completion

2016-01

Completion

2016-01-06

Outcome

Outcome not reported

Stopped (Enrollment): “The study was withdrawn prior to enrollment.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.”

Drugs

Indications