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The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care, as compared to placebo cream plus standard local wound care, in the treatment of mildly infected diabetic foot ulcers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical placebo control | Placebo Comparator |
| |
| Topical pexiganan cream 0.8% | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical pexiganan cream 0.8% | Drug | 14 days of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Response | The numbers of participants with Clinical Response, defined as resolution of infection, are reported. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Microbiological Success | The numbers of participants with Microbiological Response, defined as eradication of all initial pathogens, are reported. | 28 days |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael H. Silverman, MD | BioStrategics Consulting Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
No wash-out or run-in periods; eligible subjects were immediately assigned to treatment
Subjects recruited at outpatient clinics and practices
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical Pexiganan Cream 0.8% | Topical pexiganan cream 0.8%: 14 days of treatment + 14 days of follow-up (28-day trial period) Standard wound care: 28-day trial period |
| FG001 | Topical Placebo Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Topical placebo cream | Drug | 14 days of treatment |
|
| Standard wound care | Other | 14 days of treatment |
|
The numbers of participants with TEAEs, including those with Serious TEAEs, are reported |
| 28 days |
| Glendale |
| Arizona |
| United States |
| Mesa | Arizona | United States |
| Tucson | Arizona | United States |
| Jonesboro | Arkansas | United States |
| Bakersfield | California | United States |
| Fair Oaks | California | United States |
| Fresno | California | United States |
| Los Angeles | California | United States |
| Boynton Beach | Florida | United States |
| Hialeah | Florida | United States |
| Miami | Florida | United States |
| North Miami Beach | Florida | United States |
| South Miami | Florida | United States |
| Lexington | Kentucky | United States |
| Baltimore | Maryland | United States |
| Cambridge | Massachusetts | United States |
| Missoula | Montana | United States |
| Las Vegas | Nevada | United States |
| Emerson | New Jersey | United States |
| Greenville | North Carolina | United States |
| Toledo | Ohio | United States |
| Pittsburgh | Pennsylvania | United States |
| Aiken | South Carolina | United States |
| Baytown | Texas | United States |
| Dallas | Texas | United States |
| McAllen | Texas | United States |
| McKinney | Texas | United States |
| San Antonio | Texas | United States |
| Salt Lake City | Utah | United States |
Topical placebo cream: 14 days of treatment + 14 days of follow-up (28-day trial period)
Standard wound care: 28-day trial period
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topical Pexiganan Cream 0.8% | Topical pexiganan cream 0.8%: 14 days of treatment Standard wound care: 28-day trial period |
| BG001 | Topical Placebo Control | Topical placebo cream: 14 days of treatment Standard wound care: 28-day trial period |
| BG002 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Wound surface area | Count of Participants | 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 | Number of Participants With Clinical Response | The numbers of participants with Clinical Response, defined as resolution of infection, are reported. | Intent-To-Treat | Posted | Count of Participants | Participants | 28 days |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Microbiological Success | The numbers of participants with Microbiological Response, defined as eradication of all initial pathogens, are reported. | Intent-To-Treat Microbiological (positive for baseline pathogens) | Posted | Count of Participants | Participants | 28 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAE) | The numbers of participants with TEAEs, including those with Serious TEAEs, are reported | Safety | Posted | Count of Participants | Participants | 28 days |
|
|
28 days
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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 | Topical Pexiganan Cream 0.8% | Topical pexiganan cream 0.8%: 14 days of treatment | 0 | 85 | 9 | 85 | 6 | 85 |
| EG001 | Topical Placebo Control | Topical placebo cream: 14 days of treatment | 0 | 104 | 3 | 104 | 4 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteomyelitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Diabetes inadequate control | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
|
If no multi-site publication within 18 months of study completion, Site shall have right to publish subject to: 1) Prior to submitting/presenting, Site shall provide Sponsor a copy; Sponsor shall have 60 days to review/comment. 2) Site shall remove any Confidential Information prior to submitting/presenting the materials. 3) Site shall further delay publication/presentation for up to 120 days to allow Sponsor to protect its interests in any Sponsor Inventions described in any such materials.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert J DeLuccia | Dipexium Pharmaceuticals, Inc | +19145226503 | delucciarj@gmail.com |
| ID | Term |
|---|---|
| C093828 | pexiganan |
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| Male |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 - <2 sq cm |
|
| >=2 sq cm |
|
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