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| Name | Class |
|---|---|
| Integrium | INDUSTRY |
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The purpose of the study is to determine if DSC127 is effective in increasing incidence of complete wound closure at 10 weeks confirmed at a visit 2 weeks later when compared to the vehicle (gel without active ingredient) in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 0.75 - 6 cm2 in size.
Subjects will undergo a two week screening period to assess plantar ulcer healing, and those healing less than 30% will be eligible for randomization, providing they meet all other inclusion criteria. Four weeks of blinded "treatment" follows the screening period, and an observation period of six weeks (to 10 weeks post first treatment) follows the 4-week treatment period. If the ulcer closes during the treatment or observation period, the closure will be confirmed two weeks later, and at this time the subject enters a durability assessment period of up to 12 weeks.
All aspects of Standard of Care are followed throughout the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSC127 | Active Comparator | DSC127 0.03% in a vehicle gel (hydroxyethyl cellulose (HEC) with parabens) |
|
| Vehicle gel | Placebo Comparator | Vehicle gel comprising HEC with parabens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSC127 | Drug | DSC127 0.03%, daily topical application to diabetic foot ulcer for a period of up to 28 days or until ulcer closure, whichever is sooner |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with a target ulcer which achieves complete wound closure (skin re-epithelialization without drainage or dressing requirements) up to 10 weeks (confirmed at a study visit 2 weeks later). | Primary endpoint of complete closure is assessed by the Principal Investigator at the site; ulcer measurements are calculated through tracings submitted to the Canfield system and photographs are collected as confirmation of closure via the Canfield system. | Target ulcer must achieve complete wound closure by 10 weeks post first treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the visit where the target ulcer achieves confirmed complete wound closure | Weekly assessments to ten weeks post first treatment dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percent reduction in ulcer area per week (closure rate) | Calculated weekly for up to ten weeks | Weekly ulcer tracings to calculate area of ulcer, measurements continue to ten weeks post first treatment dose |
| Incidence of target ulcer recurrence, time to ulcer recurrence, and number of days target ulcer remains closed after confirmed complete wound closure has been established. |
Inclusion Criteria:
Male or female ambulatory subject age ≥18 years at the time of informed consent
Has type 1 or type 2 DM under metabolic control as confirmed by a glycosylated hemoglobin (HbA1c) of ≤12% and a serum creatinine level of ≤3mg/dL
At Screening and at Baseline (prior to randomization), subject has at least one ulcer that fulfills all of the following criteria:
Present for ≥1 month and ≤1 year
Partial- or full- thickness and not involving bone, tendon, or capsule (probing to tendon or capsule), i.e. Wagner Grade 1 or 2
Has no sign of infection or osteomyelitis
Plantar neuropathic ulcer; ulcer must be predominantly on the plantar surface of the foot to ensure adequate off-loading and may include the toes
Size of the target ulcer must be 0.75 - 6 cm2
Target ulcer must be non-healing as defined as <30% reduction in size in response to standard of care during the two week Screening Period
Has an ankle brachial index (ABI) ≥ 0.7 on the foot with the target ulcer
Has an assessment of the baseline level of neuropathy of the foot using Semmes-Weinstein filaments.
A female subject of childbearing potential must have a negative serum pregnancy test at the time of Screening, and must be willing to use a medically acceptable method of birth control, such as Essure®, hormonal contraception (oral pills, implantable device, or skin patch), intrauterine device, tubal ligation, or double barrier throughout the study. A female subject of childbearing potential who practices abstinence is not required to employ birth control.
Has the ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study or initiation of study procedures
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gere S diZerega, MD | Integra LifeSciences Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WILMAX Clinical Research Inc | Mobile | Alabama | 36680 | United States | ||
| Center for Clinical Research |
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| placebo vehicle gel | Drug |
|
| Assessed during a 12 week durability period following the confirmation of complete wound closure |
| Fair Oaks |
| California |
| 95628 |
| United States |
| Roy O Kroeker, DPM, Inc | Fresno | California | 93710 | United States |
| Foot and Ankle Clinic | Los Angeles | California | 90010 | United States |
| Brian O'Carroll, DPM, Inc. | Pismo Beach | California | 93449 | United States |
| UCLA Medical Center - Olive View | Sylmar | California | 91342 | United States |
| Orange County Research Center | Tustin | California | 92780 | United States |
| Advanced Research Institute of Miami | Homestead | Florida | 33030 | United States |
| UF Health Orthopaedic Surgery Clinic | Jacksonville | Florida | 32209 | United States |
| Miami Dade Medical Research Institute | Miami | Florida | 33176 | United States |
| GF Professional Research | Miami Lakes | Florida | 33016 | United States |
| Barry University Clinical Research | North Miami Beach | Florida | 33013 | United States |
| Professional Health Care of Pinellas | St. Petersburg | Florida | 33713 | United States |
| Memorial Medical Group | Granger | Indiana | 46530 | United States |
| LaPorte Medical Group | La Porte | Indiana | 46350 | United States |
| Boston University Medical Center | Boston | Massachusetts | 02118 | United States |
| East Carolina Foot and Ankle Specialists | Greenville | North Carolina | 27834 | United States |
| Clinical Research Center | Eugene | Oregon | 97401 | United States |
| Center for Clinical Research | Portland | Oregon | 97232 | United States |
| Carolina Musculoskeletel Institute | Aiken | South Carolina | 29801 | United States |
| ClinSearch, LLC | Chattanooga | Tennessee | 37421 | United States |
| Dallas VA Medical Center | Dallas | Texas | 75216 | United States |
| Fort Worth Diagnostic Clinic | Fort Worth | Texas | 76104 | United States |
| Endeavor Clinical Trials | San Antonio | Texas | 78229 | United States |
| Professional Education and Research Institute | Roanoke | Virginia | 24016 | United States |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| 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 |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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| ID | Term |
|---|---|
| C000629415 | aclerastide |
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