search
Back to results

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

Primary Purpose

Foot Ulcer, Diabetic, Diabetic Foot

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NorLeu3-A(1-7) in a gel formulation
Sponsored by
US Biotest, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Ulcer, Diabetic focused on measuring Diabetes mellitus, Diabetic neuropathy, Peripheral vascular disease, Infection, Topical application, plantar foot ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southern Arizona VA Health Care System
  • Southern Arizona Limb Salvage Alliance (SALSA)
  • Bay Area Footcare
  • University of California, San Diego
  • Olive View - UCLA Medical Center
  • Passavant Area Hospital
  • Georgetown University Medical Center
  • Boston University School of Medicine
  • Eastern Carolina Foot & Ankle Specialists
  • Warren General Hospital Wound Clinic
  • Renaissance Hospital Dallas
  • Professional Education and Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo Vehicle Control

0.03% DSC127

0.01% DSC127

Arm Description

control placebo vehicle gel

0.03 % DSC127 in Vehicle Control

0.01% DSC127 in Vehicle Control

Outcomes

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.

Secondary Outcome Measures

The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.
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.
The Time to Re-epithelialization of the Ulcer Site.
Average time to complete re-epithelialization of baseline ulcer area.

Full Information

First Posted
November 20, 2008
Last Updated
August 27, 2012
Sponsor
US Biotest, Inc.
Collaborators
National Institutes of Health (NIH), Integra LifeSciences Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00796744
Brief Title
Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers
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 Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Biotest, Inc.
Collaborators
National Institutes of Health (NIH), Integra LifeSciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Diabetic, Diabetic Foot
Keywords
Diabetes mellitus, Diabetic neuropathy, Peripheral vascular disease, Infection, Topical application, plantar foot ulcers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Vehicle Control
Arm Type
Placebo Comparator
Arm Description
control placebo vehicle gel
Arm Title
0.03% DSC127
Arm Type
Active Comparator
Arm Description
0.03 % DSC127 in Vehicle Control
Arm Title
0.01% DSC127
Arm Type
Active Comparator
Arm Description
0.01% DSC127 in Vehicle Control
Intervention Type
Drug
Intervention Name(s)
NorLeu3-A(1-7) in a gel formulation
Other Intervention Name(s)
NorLeu3-Angiotensin(1-7), DSC127
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.
Time Frame
Duration of subject's participation (24 weeks)
Title
The Rate of Re-epithelialization of the Ulcer Site.
Description
The overall healing rate of the ulcers, based on the percent of unhealed ulcer area re-epithelialized per week.
Time Frame
12 weeks
Title
The Time to Re-epithelialization of the Ulcer Site.
Description
Average time to complete re-epithelialization of baseline ulcer area.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gere diZerega, MD
Organizational Affiliation
US Biotest, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Southern Arizona VA Health Care System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Southern Arizona Limb Salvage Alliance (SALSA)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Bay Area Footcare
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8896
Country
United States
Facility Name
Olive View - UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342-1438
Country
United States
Facility Name
Passavant Area Hospital
City
Jacksonville
State/Province
Illinois
ZIP/Postal Code
62650
Country
United States
Facility Name
Georgetown University Medical Center
City
Georgetown
State/Province
Maryland
ZIP/Postal Code
20007
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Eastern Carolina Foot & Ankle Specialists
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Warren General Hospital Wound Clinic
City
Warren
State/Province
Pennsylvania
ZIP/Postal Code
16365
Country
United States
Facility Name
Renaissance Hospital Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75224
Country
United States
Facility Name
Professional Education and Research Institute
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15953051
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. doi: 10.1111/j.1067-1927.2005.130314.x.
Results Reference
background
PubMed Identifier
12621191
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. doi: 10.1097/01.PRS.0000047403.23105.66.
Results Reference
background
PubMed Identifier
11472620
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. doi: 10.1046/j.1524-475x.2001.00238.x.
Results Reference
background
PubMed Identifier
14714558
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. doi: 10.1111/j.0906-6705.2003.00087.x.
Results Reference
background
PubMed Identifier
22672145
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs