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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Foot Ulcer, Diabetic; Diabetic Foot	Drug: NorLeu3-A(1-7) in a gel formulation	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	78 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial to Evaluate the Safety and Effectiveness of DSC127 in Treating Subjects With Diabetic Ulcers
Study Start Date :	October 2008
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	May 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Placebo Comparator: Placebo Vehicle Control; control placebo vehicle gel	Drug: NorLeu3-A(1-7) in a gel formulation; 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.; Other Names: NorLeu3-Angiotensin(1-7); DSC127
Active Comparator: 0.03% DSC127; 0.03 % DSC127 in Vehicle Control	Drug: NorLeu3-A(1-7) in a gel formulation; 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.; Other Names: NorLeu3-Angiotensin(1-7); DSC127
Active Comparator: 0.01% DSC127; 0.01% DSC127 in Vehicle Control	Drug: NorLeu3-A(1-7) in a gel formulation; 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.; Other Names: NorLeu3-Angiotensin(1-7); DSC127

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Arizona
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
Southern Arizona Limb Salvage Alliance (SALSA)
Tucson, Arizona, United States, 85724
United States, California
Bay Area Footcare
Castro Valley, California, United States, 94546
University of California, San Diego
San Diego, California, United States, 92103-8896
Olive View - UCLA Medical Center
Sylmar, California, United States, 91342-1438
United States, Illinois
Passavant Area Hospital
Jacksonville, Illinois, United States, 62650
United States, Maryland
Georgetown University Medical Center
Georgetown, Maryland, United States, 20007
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, North Carolina
Eastern Carolina Foot & Ankle Specialists
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
Warren General Hospital Wound Clinic
Warren, Pennsylvania, United States, 16365
United States, Texas
Renaissance Hospital Dallas
Dallas, Texas, United States, 75224
United States, Virginia
Professional Education and Research Institute
Roanoke, Virginia, United States, 24016

Sponsors and Collaborators

US Biotest, Inc.

National Institutes of Health (NIH)

Integra LifeSciences Corporation

Investigators

Study Director:	Gere diZerega, MD	US Biotest, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Balingit PP, Armstrong DG, Reyzelman AM, Bolton L, Verco SJ, Rodgers KE, Nigh KA, diZerega GS. NorLeu3-A(1-7) stimulation of diabetic foot ulcer healing: results of a randomized, parallel-group, double-blind, placebo-controlled phase 2 clinical trial. Wound Repair Regen. 2012 Jul-Aug;20(4):482-90. doi: 10.1111/j.1524-475X.2012.00804.x. Epub 2012 Jun 7.

Other Publications:

Rodgers KE, Ellefson DD, Espinoza T, Roda N, Maldonado S, Dizerega GS. Effect of NorLeu3-A(1-7) on scar formation over time after full-thickness incision injury in the rat. Wound Repair Regen. 2005 May-Jun;13(3):309-17.

Rodgers KE, Espinoza T, Felix J, Roda N, Maldonado S, diZerega G. Acceleration of healing, reduction of fibrotic scar, and normalization of tissue architecture by an angiotensin analogue, NorLeu3-A(1-7). Plast Reconstr Surg. 2003 Mar;111(3):1195-206.

Rodgers K, Xiong S, Felix J, Roda N, Espinoza T, Maldonado S, Dizerega G. Development of angiotensin (1-7) as an agent to accelerate dermal repair. Wound Repair Regen. 2001 May-Jun;9(3):238-47.

Rodgers KE, Roda N, Felix JE, Espinoza T, Maldonado S, diZerega G. Histological evaluation of the effects of angiotensin peptides on wound repair in diabetic mice. Exp Dermatol. 2003 Dec;12(6):784-90.

Responsible Party:	US Biotest, Inc.
ClinicalTrials.gov Identifier:	NCT00796744 History of Changes
Other Study ID Numbers:	DSC127-2008-01
First Posted:	November 24, 2008
Results First Posted:	September 27, 2012
Last Update Posted:	September 27, 2012
Last Verified:	August 2012

Keywords provided by US Biotest, Inc.:

Diabetes mellitus; Diabetic neuropathy; Peripheral vascular disease	Infection; Topical application; plantar foot ulcers

Additional relevant MeSH terms:

Ulcer; Diabetic Foot; Foot Ulcer; Pathologic Processes; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer	Skin Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases; Angiotensin I (1-7); Antihypertensive Agents; Vasodilator Agents