Trial · NCT00593567
Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With a Mild Infection of a Foot Ulcer
NCT00593567, Phase 2, Completed, Innocoll; results first posted 2022-05-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With a Mild Infection of a Foot Ulcer. Trials, record NCT00593567. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00593567
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With a Mild Infection of a Foot Ulcer
- NCT number
- NCT00593567
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- Innocoll
- Conditions
- Diabetic Foot Ulcer
- Interventions
- gentamicin-collagen sponge, Levofloxacin
- First posted
- 2008-01-15
- Last updated
- 2022-05-31
- Results first posted
- 2022-05-31
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Clinical Outcome of "Clinical Cure" | Final Study Visit (Day 21 [or 28 or 35]) | Number of Participants with a clinical outcome of "clinical cure" at final visit. Clinical Cure is defined as positive clinical response and with pathogen eradication. |
| Secondary | Number of Participants With a Clinical Outcome of "Clinical Cure" in Each Treatment Group | Each time point (Day 3, 7 [14 and 21 if necessary]) | Number of participants with a clinical outcome of "clinical cure" in each treatment group at/by each time point (except the Final Study Visit). Clinical Cure is defined as positive clinical response and with pathogen eradication. |
| Secondary | Time to Baseline Pathogen Eradication | assessed at each time point on days 7, 14, 21, time to pathogen eradication from baseline up to day 21 reported | |
| Secondary | Number of Participants With Complete Wound Closure by Each Visit | At each timepoint Day 3, 7, 14 & 21 | |
| Secondary | Time to Clinical Cure | Actual time assessed (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35]) | Time to Clinical Cure is measured by days to the first observed cure. Clinical Cure is defined as positive clinical response and with pathogen eradication. |
| Secondary | Time to Pathogen Eradication | Actual time assessed (Day 1-21 | Time to Baseline Pathogen Eradication summed |
| Secondary | Time to Positive Clinical Response | (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35]) |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Clinical Outcome of Clinical Cure | Final Study Visit (Day 21 [or 28 or 35]) | Modified Intent-to-Treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Clinical Outcome of Clinical Cure in Each Treatment Group | Each time point (Day 3, 7 [14 and 21 if necessary]) | Modified intent to treat population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Baseline Pathogen Eradication | assessed at each time point on days 7, 14, 21, time to pathogen eradication from baseline up to day 21 reported | mITT | Days | MEDIAN |
| SECONDARY | Number of Participants With Complete Wound Closure by Each Visit | At each timepoint Day 3, 7, 14 & 21 | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Clinical Cure | Actual time assessed (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35]) | Modified ITT | Days | MEDIAN |
| SECONDARY | Time to Pathogen Eradication | Actual time assessed (Day 1-21 | Micro Modified Intent-to-Treat Population | Days | MEDIAN |
| SECONDARY | Time to Positive Clinical Response | (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35]) | mITT | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Clinical Outcome of Clinical Cure | Gentamicin Sponge | 14 | Participants | ||
| Number of Participants With a Clinical Outcome of Clinical Cure | Levofloxacin | 7 | Participants | ||
| Number of Participants With a Clinical Outcome of Clinical Cure in Each Treatment Group | Gentamicin Sponge | Visit 2 Day 3 | 0 | Participants | |
| Number of Participants With a Clinical Outcome of Clinical Cure in Each Treatment Group | Levofloxacin | Visit 2 Day 3 | 0 | Participants | |
| Number of Participants With a Clinical Outcome of Clinical Cure in Each Treatment Group | Gentamicin Sponge | Visit 3 Day 7 | 4 | Participants | |
| Number of Participants With a Clinical Outcome of Clinical Cure in Each Treatment Group | Levofloxacin | Visit 3 Day 7 | 0 | Participants | |
| Number of Participants With a Clinical Outcome of Clinical Cure in Each Treatment Group | Gentamicin Sponge | Visit 4 Day 14 | 4 | Participants | |
| Number of Participants With a Clinical Outcome of Clinical Cure in Each Treatment Group | Levofloxacin | Visit 4 Day 14 | 6 | Participants | |
| Number of Participants With a Clinical Outcome of Clinical Cure in Each Treatment Group | Gentamicin Sponge | Visit 5 Day 21 | 8 | Participants | |
| Number of Participants With a Clinical Outcome of Clinical Cure in Each Treatment Group | Levofloxacin | Visit 5 Day 21 | 0 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gentamicin Sponge | 48 | |
| Overall Study | STARTED | Levofloxacin | 22 | |
| Overall Study | COMPLETED | Gentamicin Sponge | 28 | |
| Overall Study | COMPLETED | Levofloxacin | 12 | |
| Overall Study | NOT COMPLETED | Gentamicin Sponge | 20 | |
| Overall Study | NOT COMPLETED | Levofloxacin | 10 |
Source ClinicalTrials.gov
Adverse events70
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Gentamicin Sponge | 2 | 47 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Levofloxacin | 1 | 22 | 1 |
| other | Vomiting | Gastrointestinal disorders | Gentamicin Sponge | 1 | 47 | 1 |
| other | Vomiting | Gastrointestinal disorders | Levofloxacin | 1 | 22 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Gentamicin Sponge | 0 | 47 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Levofloxacin | 1 | 22 | 1 |
| other | Nausea | Gastrointestinal disorders | Gentamicin Sponge | 0 | 47 | 0 |
| other | Nausea | Gastrointestinal disorders | Levofloxacin | 1 | 22 | 1 |
| other | Stomach discomfort | Gastrointestinal disorders | Gentamicin Sponge | 0 | 47 | 0 |
| other | Stomach discomfort | Gastrointestinal disorders | Levofloxacin | 1 | 22 | 1 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gentamicin Sponge | 0 | 47 |
| Total, all-cause mortality | Levofloxacin | 0 | 22 |
| Total, other adverse events | Gentamicin Sponge | 15 | 47 |
| Total, other adverse events | Levofloxacin | 5 | 22 |
| Total, serious adverse events | Gentamicin Sponge | 0 | 47 |
| Total, serious adverse events | Levofloxacin | 0 | 22 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gentamicin Sponge vs Levofloxacin: deaths from any cause | Trial comparisons |
| Gentamicin Sponge vs Levofloxacin: Number of Participants With a Clinical Outcome of Clinical Cure | Trial comparisons |
| Gentamicin Sponge vs Levofloxacin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00593567
GET https://conductscience.org/api/trials/v1/NCT00593567/results?page=2