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

Diabetic Foot Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00796744
• Other study ID #: DSC127-2008-01
• Status: Completed
• Phase: Phase 2
• First received: November 20, 2008
• Last updated: August 27, 2012
• Start date: October 2008
• Est. completion date: May 2011

Study information

• Verified date: August 2012
• Source: US Biotest, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Bay Area Footcare	Castro Valley	California
United States	Renaissance Hospital Dallas	Dallas	Texas
United States	Georgetown University Medical Center	Georgetown	Maryland
United States	Eastern Carolina Foot & Ankle Specialists	Greenville	North Carolina
United States	Passavant Area Hospital	Jacksonville	Illinois
United States	Professional Education and Research Institute	Roanoke	Virginia
United States	University of California, San Diego	San Diego	California
United States	Olive View - UCLA Medical Center	Sylmar	California
United States	Southern Arizona Limb Salvage Alliance (SALSA)	Tucson	Arizona
United States	Southern Arizona VA Health Care System	Tucson	Arizona
United States	Warren General Hospital Wound Clinic	Warren	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
US Biotest, Inc.	Derma Sciences, Inc., National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Wou — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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