Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers
NCT ID: NCT00796744
Last Updated: 2012-09-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
78 participants
INTERVENTIONAL
2008-10-31
2011-05-31
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo Vehicle Control
control placebo vehicle gel
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.
0.03% DSC127
0.03 % DSC127 in Vehicle Control
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.
0.01% DSC127
0.01% DSC127 in Vehicle Control
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Integra LifeSciences Corporation
INDUSTRY
US Biotest, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gere diZerega, MD
Role: STUDY_DIRECTOR
US Biotest, Inc.
Locations
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Southern Arizona VA Health Care System
Tucson, Arizona, United States
Southern Arizona Limb Salvage Alliance (SALSA)
Tucson, Arizona, United States
Bay Area Footcare
Castro Valley, California, United States
University of California, San Diego
San Diego, California, United States
Olive View - UCLA Medical Center
Sylmar, California, United States
Passavant Area Hospital
Jacksonville, Illinois, United States
Georgetown University Medical Center
Georgetown, Maryland, United States
Boston University School of Medicine
Boston, Massachusetts, United States
Eastern Carolina Foot & Ankle Specialists
Greenville, North Carolina, United States
Warren General Hospital Wound Clinic
Warren, Pennsylvania, United States
Renaissance Hospital Dallas
Dallas, Texas, United States
Professional Education and Research Institute
Roanoke, Virginia, United States
Countries
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References
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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. doi: 10.1111/j.1067-1927.2005.130314.x.
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. doi: 10.1097/01.PRS.0000047403.23105.66.
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. doi: 10.1046/j.1524-475x.2001.00238.x.
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. doi: 10.1111/j.0906-6705.2003.00087.x.
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 Identifiers
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DSC127-2008-01
Identifier Type: -
Identifier Source: org_study_id