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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Integra LifeSciences Corporation | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Vehicle Control | Placebo Comparator | control placebo vehicle gel |
|
| 0.03% DSC127 | Active Comparator | 0.03 % DSC127 in Vehicle Control |
|
| 0.01% DSC127 | Active Comparator | 0.01% DSC127 in Vehicle Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The overall healing rate of the ulcers, based on the percent of unhealed ulcer area re-epithelialized per week. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gere diZerega, MD | US Biotest, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Arizona VA Health Care System | Tucson | Arizona | 85723 | United States | ||
| Southern Arizona Limb Salvage Alliance (SALSA) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15953051 | Background | 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. | |
| 12621191 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Vehicle Control | control placebo vehicle |
| FG001 | 0.03 % DSC127 | 0.03% DSC127 in Vehicle Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| 12 weeks |
| The Time to Re-epithelialization of the Ulcer Site. | Average time to complete re-epithelialization of baseline ulcer area. | 24 weeks |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Bay Area Footcare | Castro Valley | California | 94546 | United States |
| University of California, San Diego | San Diego | California | 92103-8896 | United States |
| Olive View - UCLA Medical Center | Sylmar | California | 91342-1438 | United States |
| Passavant Area Hospital | Jacksonville | Illinois | 62650 | United States |
| Georgetown University Medical Center | Georgetown | Maryland | 20007 | United States |
| Boston University School of Medicine | Boston | Massachusetts | 02118 | United States |
| Eastern Carolina Foot & Ankle Specialists | Greenville | North Carolina | 27834 | United States |
| Warren General Hospital Wound Clinic | Warren | Pennsylvania | 16365 | United States |
| Renaissance Hospital Dallas | Dallas | Texas | 75224 | United States |
| Professional Education and Research Institute | Roanoke | Virginia | 24016 | United States |
| 11472620 | 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. |
| 14714558 | 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. |
| 22672145 | Result | 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. |
| FG002 |
| 0.01% DSC127 |
0.01% DSC127 in Vehicle Control |
| COMPLETED |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Vehicle Control | control placebo vehicle |
| BG001 | 0.03 % DSC127 | 0.03% DSC127 in Vehicle Control |
| BG002 | 0.01% DSC127 | 0.01% DSC127 in Vehicle Control |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage. | Intent-to-Treat Population | Posted | Number | number of ulcers healed | Healing to occur within 12 weeks of first treatment |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | The Proportion of Subjects in Each Treatment Group Reporting Adverse Events. | Safety Population | Posted | Number | patients | Duration of subject's participation (24 weeks) |
|
| ||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | percent ulcer area re-epithelialized/wk | 12 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | The Time to Re-epithelialization of the Ulcer Site. | Average time to complete re-epithelialization of baseline ulcer area. | Posted | Mean | Standard Error | Weeks | 24 weeks |
|
|
24 weeks
Maximum subject participation period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Vehicle Control | control placebo vehicle | 5 | 24 | 16 | 24 | ||
| EG001 | 0.03 % DSC127 | 0.03% DSC127 in Vehicle Control | 4 | 26 | 15 | 26 | ||
| EG002 | 0.01% DSC127 | 0.01% DSC127 in Vehicle Control | 4 | 28 | 18 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial infarction | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Foot Amputation | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
| |
| Joint Arthroplasty | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
| |
| Spinal Fusion Surgery | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
| |
| Tendon Operation | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Diabetic foot infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Blood Glucose Increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Diabetic Foot | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Skin Maceration | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
The sponsor prepared an integrated clinical/statistical report. As this was a multicenter study, any publication/presentation of data was to include the entire study population. Publication/presentation of data from individual study centers is not allowed without explicit permission from US Biotest.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shelagh Verco | US Biotest | 805-595-1300 | shelagh.verco@usbiotest.com |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003920 | Diabetes Mellitus |
| D003929 | Diabetic Neuropathies |
| D016491 | Peripheral Vascular Diseases |
| D007239 | Infections |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C473306 | norLeu3-A(1-7) |
| C000629415 | aclerastide |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
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|
|