Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers
Public ClinicalTrials.gov record NCT02427802. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Randomized, Placebo-Controlled, Blinded Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge in Combination With Systemic Antibiotic Therapy in Diabetic Patients With an Infected Foot Ulcer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with either (A) daily application of a gentamicin-sponge, (B) daily application of a placebo-sponge or (C) no-sponge, in the ratio 2:1:1. Patients will be treated for approximately 28 days and return to the clinic weekly for safety and efficacy assessments. After completing treatment, patients will return to the clinic for scheduled follow-up visits approximately 10, 30, 60 and 90 days after treatment is stopped.
Study identification
- NCT ID
- NCT02427802
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 612 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2015 (Type not available)
- Primary completion
- Oct 2016 (Actual)
- Completion
- Oct 2016 (Actual)
- Last update posted
- Aug 25, 2021
2015 – 2016
United States locations
- U.S. sites
- 86
- U.S. states
- 25
- U.S. cities
- 70
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Anniston | Alabama | 36207 | — |
| Not listed | Mobile | Alabama | 36608 | — |
| Not listed | Mesa | Arizona | 85206 | — |
| Not listed | Phoenix | Arizona | 85032 | — |
| Not listed | Fayetteville | Arkansas | 72703 | — |
| Not listed | Jonesboro | Arkansas | 72401 | — |
| Not listed | Little Rock | Arkansas | 72205 | — |
| Not listed | Little Rock | Arkansas | 72212 | — |
| Not listed | Bakersfield | California | 93301 | — |
| Not listed | Chino | California | 91710 | — |
| Not listed | Corona | California | 92882 | — |
| Not listed | Fountain Valley | California | 36207 | — |
| Not listed | Fresno | California | 93720 | — |
| Not listed | Fresno | California | 93721 | — |
| Not listed | Fresno | California | 93722 | — |
| Not listed | Long Beach | California | 90822 | — |
| Not listed | Los Angeles | California | 90057 | — |
| Not listed | Oakland | California | 94609 | — |
| Not listed | San Francisco | California | 94115 | — |
| Not listed | Sylmar | California | 91342 | — |
| Not listed | Norwalk | Connecticut | 06851 | — |
| Not listed | Washington D.C. | District of Columbia | 20007 | — |
| Not listed | Clermont | Florida | 34711 | — |
| Not listed | Cooper City | Florida | 33024 | — |
| Not listed | Coral Gables | Florida | 33134 | — |
| Not listed | Coral Gables | Florida | 33146 | — |
| Not listed | DeLand | Florida | 32720 | — |
| Not listed | Fleming Island | Florida | 32003 | — |
| Not listed | Hialeah | Florida | 33012 | — |
| Not listed | Hialeah | Florida | 33016 | — |
| Not listed | Hollywood | Florida | 33024 | — |
| Not listed | Miami | Florida | 33122 | — |
| Not listed | Miami | Florida | 33126 | — |
| Not listed | Miami | Florida | 33135 | — |
| Not listed | Miami | Florida | 33136 | — |
| Not listed | Miami | Florida | 33155 | — |
| Not listed | Miami | Florida | 33174 | — |
| Not listed | Miami | Florida | 33175 | — |
| Not listed | Miami | Florida | 33185 | — |
| Not listed | Miami Lakes | Florida | 33016 | — |
| Not listed | Miami Springs | Florida | 33166 | — |
| Not listed | New Port Richey | Florida | 34653 | — |
| Not listed | St. Petersburg | Florida | 33713 | — |
| Not listed | West Palm Beach | Florida | 33406 | — |
| Not listed | Weston | Florida | 33326 | — |
| Not listed | Augusta | Georgia | 30907 | — |
| Not listed | Columbus | Georgia | 31904 | — |
| Not listed | Marietta | Georgia | 30060 | — |
| Not listed | Idaho Falls | Idaho | 83404 | — |
| Not listed | Avon | Indiana | 46123 | — |
| Not listed | Mooresville | Indiana | 46158 | — |
| Not listed | Muncie | Indiana | 47304 | — |
| Not listed | Baltimore | Maryland | 21215 | — |
| Not listed | Phoenix | Maryland | 21131 | — |
| Not listed | Boston | Massachusetts | 02118 | — |
| Not listed | Flint | Michigan | 48504 | — |
| Not listed | Butte | Montana | 59701 | — |
| Not listed | Great Falls | Montana | 59405 | — |
| Not listed | Las Vegas | Nevada | 89101 | — |
| Not listed | North Brunswick | New Jersey | 08902 | — |
| Not listed | Somerset | New Jersey | 08873 | — |
| Not listed | Hopewell Junction | New York | 12533 | — |
| Not listed | New Windsor | New York | 12553 | — |
| Not listed | Durham | North Carolina | 27710 | — |
| Not listed | Lima | Ohio | 45801 | — |
| Not listed | Oklahoma City | Oklahoma | 73104 | — |
| Not listed | Oklahoma City | Oklahoma | 73139 | — |
| Not listed | Philadelphia | Pennsylvania | 19103 | — |
| Not listed | Philadelphia | Pennsylvania | 19106 | — |
| Not listed | Greenville | South Carolina | 29605 | — |
| Not listed | Myrtle Beach | South Carolina | 29572 | — |
| Not listed | West Columbia | South Carolina | 29169 | — |
| Not listed | Dallas | Texas | 75224 | — |
| Not listed | Houston | Texas | 77024 | — |
| Not listed | Lampasas | Texas | 76550 | — |
| Not listed | Lubbock | Texas | 79410 | — |
| Not listed | McAllen | Texas | 78501 | — |
| Not listed | North Richland Hills | Texas | 76180 | — |
| Not listed | San Antonio | Texas | 78209 | — |
| Not listed | San Antonio | Texas | 78224 | — |
| Not listed | San Antonio | Texas | 78229 | — |
| Not listed | Sugar Land | Texas | 77479 | — |
| Not listed | Webster | Texas | 77598 | — |
| Not listed | Norfolk | Virginia | 23507 | — |
| Not listed | Virginia Beach | Virginia | 23464 | — |
| Not listed | Wenatchee | Washington | 98801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02427802, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2021 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02427802 live on ClinicalTrials.gov.