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| Name | Class |
|---|---|
| Integrium | INDUSTRY |
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To evaluate the safety of topical 0.03% DSC127 Gel when used for one or more continuous treatment periods on a chronic Wagner Grade 1 or 2 foot ulcer(target ulcer) or multiple ulcers in diabetic subjects. The maximum duration of any treatment period is 24 weeks.
All eligible subjects enrolled will begin daily Treatment with topical 0.03% DSC127 gel until complete wound closure (defined as skin re-epithelialization without drainage or dressing requirement) or 24 weeks, whichever occurs first.
If a patient has multiple ulcers on one foot, all may be treated, within the maximum of 24 weeks. If the ulcer does not heal, after a wash out period of 1 week, a new treatment period of up to 24 weeks may be initiated. Ulcer may be retreated if it recurs or if a new ulcer develops that meets study criteria.
For the entire duration of each treatment period the standard of care for DFU will be maintained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.03% DSC127 topical gel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.03% DSC127 topical gel | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of all subjects reporting Adverse Events and Serious Adverse Events related to study treatment | 2.5yrs |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in laboratory evaluations (clinically significant changes) | 2.5yrs | |
| Proportion of all subjects treated and terminating prematurely due to adverse events related to study treatment. | 2.5yrs |
Inclusion Criteria:
Male or female ambulatory subjects who are at least 18 years of age at screening
Have at least one ulcer:
Have an ABI > 0.7, or have a TcPO2 > 40 mm Hg or great toe systolic pressure > 50 mmHg to ensure healing potential.
Have Type I or Type II diabetes under metabolic control as confirmed by glycosylated hemoglobin (HbA1c) of ≤ 14%, obtained at enrollment or within 30 days prior to study enrollment.
Female subjects of child-bearing potential must have a negative pregnancy test at the time of enrollment and at the initiation of each study treatment period.
Female subjects of child-bearing potential 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, double barrier, or abstinence during the treatment periods of study participation.
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 |
|---|---|---|
| John Caminis, MD | Integra LifeSciences Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WILMAX Clinical Research | Mobile | Alabama | 36608 | United States | ||
| Reliance Institute of Clinical Research |
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| Chino |
| California |
| 91710 |
| United States |
| Roy O. Kroeker, DMP, Inc. | Fresno | California | 93710 | United States |
| Limb Preservation Platform (LPP) | Fresno | California | 93720 | United States |
| Foot and Ankle Clinic | Los Angeles | California | 90010 | United States |
| Center for Clinical Research, Inc. | San Francisco | California | 94115 | United States |
| Olive View - UCLA Medical Center | 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 |
| Phoenix Medical Research, LLC | Miami | Florida | 33165 | 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 | 33169 | United States |
| Professional Health Care of Pinellas | St. Petersburg | Florida | 33713 | United States |
| Eastern Carolina Foot & Ankle Specialists | Greenville | North Carolina | 27834 | United States |
| O'Malley Foot and Ankle | Wilmington | North Carolina | 28411 | United States |
| Martin Foot & Ankle | York | Pennsylvania | 17402 | United States |
| Carolina Musculoskeletal Institute | Aiken | South Carolina | 29801 | 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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