Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess if the experimental drug, DSC127, is safe, how well it can be tolerated, and how different doses effect the healing of the chronic foot ulcers in diabetic subjects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Biotest, Inc.
• Collaborators: Derma Sciences, Inc.; Integra LifeSciences Corporation; National Institutes of Health (NIH)
• Treatments: Angiotensin I (1-7)

Criteria

Inclusion Criteria:

• Have at least one chronic non-healing Wagner Grade 1 or Grade 2 plantar neuropathic diabetic ulcer between 1.0-6.0 cm2 on the midfoot or forefoot, including the toes but excluding the heel.

• ABI greater than 0.7 for neuroischemic or greater than 0.8 for neuropathic DU

• TcPO2 greater than 40 mm Hg or great toe systolic pressure greater than 50 mmHg

• Type I or Type II diabetes under metabolic control

• Female subjects must have a negative pregnancy test and be willing to use acceptable method of birth control for the duration of the study

Exclusion Criteria:

• Exposure to any investigational product within the last 30 days, or have known hypersensitivity to any of the study medication components

• Chronic renal insufficiency and/or chronic liver dysfunction

• Resting blood pressure (at the time of the initial visit of the Screening Period) which exceeds 160 systolic and/or 90 diastolic mmHg on 3 consecutive readings at least 15 minutes apart

• Malignancy of any kind

• Receiving hemodialysis or CAPD

• Current history of drug abuse, and/or known to be HIV positive

• Prior radiation therapy of the foot under study

• Current use of corticosteroids (within past 8 weeks), immunosuppressants (within past 8 weeks), or use of a biologic agent to include growth factors and skin equivalents (Regranex, Apligraft, or Dermagraft) in the past 90 days

• Ulcer is deemed clinically infected and requires topical antimicrobials or agents known to affect wound healing, or the subject has been taking systemic antibiotics for more than 7 days for any reason

• Sickle-cell anemia, Raynaud's or other peripheral vascular disease

• Wagner Grade 3 or higher DU, deep abscess or infection of the joint or tendon, or gangrene or osteomyelitis

• An EKG with a marked baseline prolongation of QT/QTc interval