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

Biotest

Status and phase: Completed; Phase 2

Conditions: Foot Ulcer, Diabetic; Diabetic Foot

Treatments: Drug: NorLeu3-A(1-7) in a gel formulation

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00796744

DSC127-2008-01

Details and patient eligibility

About

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.

Full description

This study is designed as a randomized, parallel-group, double-blind, placebo-controlled trial. After a 14-day baseline to evaluate ulcer healing to ensure DU are chronic, a 4-week active treatment followed by 8 weeks of observation and assessment of the treatment will compare the effects of two concentrations of DSC127 and placebo (n = 25 evaluable subjects per group; n=75 total evaluable subjects) to identify the optimal dose of DSC127. Sustained tissue integrity will be evaluated for all subjects during a follow-up period at study weeks 16 and 24.

Subjects will be randomized in a 1:1:1 ratio to one of the three treatment groups.

Group 1: Placebo Vehicle Control Group 2: 0.03% DSC127 in Vehicle Group 3: 0.01% DSC127 in Vehicle

The four week treatment period requires daily application of the treatment to the wound site. First application each week will be at the clinic and for the remainder of the week the patient self-administers the treatment.

If wound healing occurs during the treatment or assessment periods a final assessment visit is conducted and the integrity is assessed four and twelve weeks later (usually weeks 16 and 24 of the study).

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 3 patient groups, including a placebo group

Placebo Vehicle Control

Placebo Comparator group

Description:

control placebo vehicle gel

Treatment:

Drug: NorLeu3-A(1-7) in a gel formulation

0.03% DSC127

Active Comparator group

Description:

0.03 % DSC127 in Vehicle Control

Treatment:

Drug: NorLeu3-A(1-7) in a gel formulation

0.01% DSC127

Active Comparator group

Description:

0.01% DSC127 in Vehicle Control

Treatment:

Drug: NorLeu3-A(1-7) in a gel formulation