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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 | Drug: Topical placebo cream |
|
| Topical pexiganan cream 0.8% | Experimental | Drug: Topical pexiganan cream 0.8% |
|
| 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 Response | The numbers of participants with Microbiological Response, defined are eradication of all baseline 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 |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36781451 | Derived | You Y, Liu H, Zhu Y, Zheng H. Rational design of stapled antimicrobial peptides. Amino Acids. 2023 Apr;55(4):421-442. doi: 10.1007/s00726-023-03245-w. Epub 2023 Feb 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical Pexiganan Cream 0.8% | Drug: 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 number of participants with TEAEs, including Serious TEAEs, are reported |
| 28 days |
| Tucson |
| Arizona |
| United States |
| Jonesboro | Arkansas | United States |
| Castro Valley | California | United States |
| Davis | California | United States |
| Los Angeles | California | United States |
| Napa | California | United States |
| San Francisco | California | United States |
| Santa Rosa | California | United States |
| Sylmar | California | United States |
| Vacaville | California | United States |
| Norwalk | Connecticut | United States |
| Coral Gables | Florida | United States |
| Doral | Florida | United States |
| Hialeah | Florida | United States |
| Homestead | Florida | United States |
| Jacksonville | Florida | United States |
| Largo | Florida | United States |
| Miami | Florida | United States |
| Miami Lakes | Florida | United States |
| Miami Shores | Florida | United States |
| Pinellas Park | Florida | United States |
| Evans | Georgia | United States |
| North Chicago | Illinois | United States |
| Hutchinson | Kansas | United States |
| New Orleans | Louisiana | United States |
| Mineola | New York | United States |
| Charlotte | North Carolina | United States |
| Wilmington | North Carolina | United States |
| Duncansville | Pennsylvania | United States |
| York | Pennsylvania | United States |
| Columbia | South Carolina | United States |
| El Paso | Texas | United States |
| Fort Worth | Texas | United States |
| Lewisville | Texas | United States |
| Salt Lake City | Utah | United States |
| St. George | Utah | United States |
| Roanoke | Virginia | United States |
| Richland | Washington | United States |
Drug: Topical placebo cream Topical placebo cream: 14 days of treatment + 14 days of follow-up (28-day trial period) Standard wound care: 28-day trial period |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topical Pexiganan Cream 0.8% | Drug: 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 | Drug: Topical placebo cream 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 Response | The numbers of participants with Microbiological Response, defined are eradication of all baseline 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 number of participants with TEAEs, including 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% | Drug: Topical pexiganan cream 0.8% Topical pexiganan cream 0.8%: 14 days of treatment | 0 | 97 | 8 | 97 | 6 | 97 |
| EG001 | Topical Placebo Control | Drug: Topical placebo cream Topical placebo cream: 14 days of treatment | 0 | 103 | 2 | 103 | 0 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Diabetic ketoacidiosis | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Foot surgery | Surgical and medical procedures | MedDRA (17.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteomyelitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal 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 |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| 1 - <2 sq cm |
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| >=2 sq cm |
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| Missing |
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