Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers - Full Text View

Sponsor:	US Biotest, Inc.
Collaborators:	National Institutes of Health (NIH) Derma Sciences, Inc.
Information provided by:	US Biotest, Inc.
ClinicalTrials.gov Identifier:	NCT00796744

Purpose

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	Intervention	Phase
Foot Ulcer, Diabetic Diabetic Foot	Drug: NorLeu3-A(1-7) in a gel formulation	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Foot Foot Health

U.S. FDA Resources

Further study details as provided by US Biotest, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The proportion of subjects in each treatment group reporting adverse events, by severity and relationship to study medication as assessed by the investigator. [ Time Frame: Duration of subject's participation ] [ Designated as safety issue: Yes ]
The rate of re-epithelialization of the ulcer site, percentage of ulcers that are re-epithelialized at 3, 5, 7, 9 and 12 weeks, time to re-epithelialization of the ulcer site, and DU percent contraction and depth reduction in millimeter and percent. [ Time Frame: Duration of subject's participation ] [ Designated as safety issue: Yes ]
Differences among treatment groups in time-to-re-epithelization and changes in DU mm and % depth and estimated ulcer site area. [ Time Frame: Duration of subject's participation ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	75
Study Start Date:	October 2008
Study Completion Date:	May 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo Vehicle Control without DSC127	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: 2 0.03 % DSC127 in Vehicle	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: 3 0.01% DSC127 in Vehicle	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

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 an the integrity is assessed four and twelve weeks later (usually weeks 16 and 24 of the study).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796744

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)

Derma Sciences, Inc.

Investigators

Study Director:

Gere diZerega, MD

US Biotest, Inc.

More Information

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:	Dr Gere diZerega / CEO, US Biotest Inc
ClinicalTrials.gov Identifier:	NCT00796744 History of Changes
Other Study ID Numbers:	DSC127-2008-01
Study First Received:	November 20, 2008
Last Updated:	May 26, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by US Biotest, Inc.:

Diabetes mellitus
Diabetic neuropathy
Peripheral vascular disease

Infection
Topical application
plantar foot ulcers

Additional relevant MeSH terms:

Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases

Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Angiotensin I (1-7)
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012