Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers
Condition: Foot Ulcer, Diabetic; Diabetic Foot
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Intervention: NorLeu3-A(1-7) in a gel formulation
Intervention description: Gel will be applied to the wound once daily for four weeks (treatment period). Gel will have either no active ingredient (placebo), 0.03% or 0.01% active ingredient.
Intervention MeSH terms: Angiotensin I (1-7)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes mellitus; Diabetic neuropathy; Peripheral vascular disease; Infection; Topical application; plantar foot ulcers

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.
    

Eligibility 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