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

NCT00796744 | Completed Phase 2 Results

• 1 other identifier: DSC127-2008-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 12

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.

Conditions

Foot Ulcer, Diabetic; Diabetic Foot

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Time to Re-epithelialization of the Ulcer Site.

  24 weeks

Study Arms (3)

Placebo Vehicle Control

PLACEBO COMPARATOR

control placebo vehicle gel

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

0.03% DSC127

ACTIVE COMPARATOR

0.03 % DSC127 in Vehicle Control

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

0.01% DSC127

ACTIVE COMPARATOR

0.01% DSC127 in Vehicle Control

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

Interventions

NorLeu3-A(1-7) in a gel formulation DRUG

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.

Also known as: NorLeu3-Angiotensin(1-7), DSC127

0.01% DSC127; 0.03% DSC127; Placebo Vehicle Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Biotest, Inc.: lead
• National Institutes of Health (NIH): collaborator
• Integra LifeSciences Corporation: collaborator

Study Sites (12)

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

Location

Southern Arizona Limb Salvage Alliance (SALSA)

Tucson, Arizona, 85724, United States

Location

Bay Area Footcare

Castro Valley, California, 94546, United States

Location

University of California, San Diego

San Diego, California, 92103-8896, United States

Location

Olive View - UCLA Medical Center

Sylmar, California, 91342-1438, United States

Location

Passavant Area Hospital

Jacksonville, Illinois, 62650, United States

Location

Georgetown University Medical Center

Georgetown, Maryland, 20007, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Eastern Carolina Foot & Ankle Specialists

Greenville, North Carolina, 27834, United States

Location

Warren General Hospital Wound Clinic

Warren, Pennsylvania, 16365, United States

Location

Renaissance Hospital Dallas

Dallas, Texas, 75224, United States

Location

Professional Education and Research Institute

Roanoke, Virginia, 24016, United States

Location

Related Publications (5)

• 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.

  PMID: 15953051 BACKGROUND

• 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.

  PMID: 12621191 BACKGROUND

• 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.

  PMID: 11472620 BACKGROUND

• 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.

  PMID: 14714558 BACKGROUND

• 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.

  PMID: 22672145 RESULT

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Diabetic Neuropathies; Peripheral Vascular Diseases; Infections

Interventions

norLeu3-A(1-7); aclerastide

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Shelagh Verco
• Organization: US Biotest

shelagh.verco@usbiotest.com

805-595-1300

Study Officials

• Gere diZerega, MD

  US Biotest, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 24, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: May 1, 2011
• Last Updated: September 27, 2012
• Results First Posted: September 27, 2012

Record last verified: 2012-08

Locations

US (12)