Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers
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| ClinicalTrials.gov Identifier: NCT00796744 |
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Recruitment Status :
Completed
First Posted : November 24, 2008
Results First Posted : September 27, 2012
Last Update Posted : September 27, 2012
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Sponsor:
US Biotest, Inc.
Collaborators:
National Institutes of Health (NIH)
Integra LifeSciences Corporation
Information provided by (Responsible Party):
US Biotest, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Foot Ulcer, Diabetic Diabetic Foot | Drug: NorLeu3-A(1-7) in a gel formulation | Phase 2 |
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).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 78 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, 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 |
| Study Start Date : | October 2008 |
| Actual Primary Completion Date : | December 2010 |
| Actual Study Completion Date : | May 2011 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo Vehicle Control
control placebo vehicle gel
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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:
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Active Comparator: 0.03% DSC127
0.03 % DSC127 in Vehicle Control
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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:
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Active Comparator: 0.01% DSC127
0.01% DSC127 in Vehicle Control
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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:
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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 ]
Secondary Outcome Measures :
- The Proportion of Subjects in Each Treatment Group Reporting Adverse Events. [ Time Frame: Duration of subject's participation (24 weeks) ]
- The Rate of Re-epithelialization of the Ulcer Site. [ Time Frame: 12 weeks ]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. [ Time Frame: 24 weeks ]Average time to complete re-epithelialization of baseline ulcer area.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)
Integra LifeSciences Corporation
Investigators
| Study Director: | Gere diZerega, MD | US Biotest, Inc. |
Publications of Results:
Other Publications:
| Responsible Party: | US Biotest, Inc. |
| ClinicalTrials.gov Identifier: | NCT00796744 History of Changes |
| Other Study ID Numbers: |
DSC127-2008-01 |
| First Posted: | November 24, 2008 Key Record Dates |
| Results First Posted: | September 27, 2012 |
| Last Update Posted: | September 27, 2012 |
| Last Verified: | August 2012 |
Keywords provided by US Biotest, Inc.:
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Diabetes mellitus Diabetic neuropathy Peripheral vascular disease |
Infection Topical application plantar foot ulcers |
Additional relevant MeSH terms:
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Ulcer Diabetic Foot Foot Ulcer Pathologic Processes Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Leg Ulcer Skin Ulcer |
Skin Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies Foot Diseases Angiotensin I (1-7) Antihypertensive Agents Vasodilator Agents |