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

Phase 2

Completed

• Conditions: Foot Ulcer, Diabetic; Diabetic Foot
• Interventions: Drug: NorLeu3-A(1-7) in a gel formulation

• Registration Number: NCT00796744
• Lead Sponsor: US Biotest, Inc.

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-21
• Study First Posted: 2008-11-24
• Primary Completion: 2010-12
• Study Completion: 2011-05
• Disposition First Submitted: 2012-04-09
• Disposition First Submitted QC: 2012-04-09
• Disposition First Posted: 2012-04-11
• Results First Submitted: 2012-06-14
• Status Verified: 2012-08
• Results First Submitted QC: 2012-08-27
• Last Update Submitted: 2012-08-27
• Results First Posted: 2012-09-27
• Last Update Posted: 2012-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.03% DSC127	NorLeu3-A(1-7) in a gel formulation	0.03 % DSC127 in Vehicle Control
0.01% DSC127	NorLeu3-A(1-7) in a gel formulation	0.01% DSC127 in Vehicle Control
Placebo Vehicle Control	NorLeu3-A(1-7) in a gel formulation	control placebo vehicle gel

Primary Outcome Measures

Name	Time	Method
The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage.	Healing to occur within 12 weeks of first treatment

Secondary Outcome Measures

Name	Time	Method
The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.	Duration of subject's participation (24 weeks)
The Rate of Re-epithelialization of the Ulcer Site.	12 weeks	The overall healing rate of the ulcers, based on the percent of unhealed ulcer area re-epithelialized per week.
The Time to Re-epithelialization of the Ulcer Site.	24 weeks	Average time to complete re-epithelialization of baseline ulcer area.

Trial Locations

Locations (12)

Southern Arizona Limb Salvage Alliance (SALSA); 🇺🇸 Tucson, Arizona, United States

Georgetown University Medical Center; 🇺🇸 Georgetown, Maryland, United States

Renaissance Hospital Dallas; 🇺🇸 Dallas, Texas, United States

Warren General Hospital Wound Clinic; 🇺🇸 Warren, Pennsylvania, United States

Boston University School of Medicine; 🇺🇸 Boston, Massachusetts, United States

Olive View - UCLA Medical Center; 🇺🇸 Sylmar, California, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States

Professional Education and Research Institute; 🇺🇸 Roanoke, Virginia, United States

Southern Arizona VA Health Care System; 🇺🇸 Tucson, Arizona, United States

Bay Area Footcare; 🇺🇸 Castro Valley, California, United States

Eastern Carolina Foot & Ankle Specialists; 🇺🇸 Greenville, North Carolina, United States

Passavant Area Hospital; 🇺🇸 Jacksonville, Illinois, United States