Trial · NCT00659646

The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers

NCT00659646, Phase 2, Completed, Innocoll; results first posted 2021-08-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers. Trials, record NCT00659646. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00659646

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers
NCT number: NCT00659646
Status: Completed
Phases: Phase 2
Enrollment: 56 participants, actual
Lead sponsor: Innocoll
Conditions: Diabetic Foot Ulcer
Interventions: gentamicin-collagen sponge and levofloxacin, Levofloxacin only
First posted: 2008-04-16
Last updated: 2022-01-27
Results first posted: 2021-08-30

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With a Clinical Cure at Visit 3 (Day 7)	Day 7 of treatment	Number of participants with a clinical cure in each treatment group at Visit 3 (Day 7). Clinical Cure is defined as positive clinical response and with pathogen eradication.
Secondary	Number of Participants With a Positive Clinical Response at Each Time Point	Day 3, 7, 10,14, 21, 28 and 42	Number of patients with positive clinical response, defined as those with a clinical outcome of "clinical cure" or "clinical improvement" in each treatment group at/by each time point
Secondary	Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7)	Day 3, 10, 14, 21, 28 & 42	clinical cure is defined as having a positive clinical response and with pathogen eradication
Secondary	Number of Participants With Pathogen Eradication by Visit	Day 3, 7, 10, 14, 21 & 28
Secondary	Change From Baseline in Total Wound Surface Area Measured in cm^2	Day 3, 7, 10, 14, 21, 28 & 42	Wound Surface Area was measured in cm² Actual Values Total wound surface area was compared across treatments using 2-sample t-tests. Wound tracings were obtained at study visits by trained study personnel who were blinded to the patient data and regimen. A centralized imaging facility provided both wound perimeter and area measurements.
Secondary	Time to Clinical Cure	Days 1 through 49	clinical cure is defined as having a positive clinical response and with pathogen eradication
Secondary	Visual Analog Scale (VAS) for Pain Assessment	Day 3, 7, 10, 14, 21, 28 & 42	Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) at each time point. A lower score is better which means the patient experience lower pain. The score is calculated using the number of hours \* the VAS score. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. For each measure outcome - the minimum score is "0" and the maximum score is 100\* the number of hours in that period.
Secondary	Lipsky Wound Score	Days 3, 7, 10, 14, 21, 28, 42	The Lipsky wound scoring scale consists of scoring categories for purulent drainage, non-purulent drainage, erythema, induration, tenderness, pain, local warmth and wound measurements. This wound scoring system allows us to take the size and depth of the wound into consideration as well as all signs and symptoms of inflammation and infection. A quantitative score that assess wounds both at baseline and during therapy to compare wound scores over time. The higher the score the worse the inflammation and/or infection is. The Lowest score possible is "3" and the highest score possible is "64".

Source ClinicalTrials.gov

Outcomes8

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 Cure at Visit 3 (Day 7)	Day 7 of treatment	modified intent-to-treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With a Positive Clinical Response at Each Time Point	Day 3, 7, 10,14, 21, 28 and 42		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7)	Day 3, 10, 14, 21, 28 & 42	mITT	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Pathogen Eradication by Visit	Day 3, 7, 10, 14, 21 & 28	mITT	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Total Wound Surface Area Measured in cm^2	Day 3, 7, 10, 14, 21, 28 & 42	mITT	cm^2	MEAN
SECONDARY	Time to Clinical Cure	Days 1 through 49	mITT	Days	MEAN
SECONDARY	Visual Analog Scale (VAS) for Pain Assessment	Day 3, 7, 10, 14, 21, 28 & 42		score on a scale*days	MEAN
SECONDARY	Lipsky Wound Score	Days 3, 7, 10, 14, 21, 28, 42		score on a scale	MEAN

Source ClinicalTrials.gov

Results by group90

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With a Clinical Cure at Visit 3 (Day 7)	Gentamicin Sponge		0	Participants
Number of Participants With a Clinical Cure at Visit 3 (Day 7)	Levofloxacin		3	Participants
Number of Participants With a Positive Clinical Response at Each Time Point	Gentamicin Sponge	Visit 2 Day 3	24	Participants
Number of Participants With a Positive Clinical Response at Each Time Point	Levofloxacin	Visit 2 Day 3	9	Participants
Number of Participants With a Positive Clinical Response at Each Time Point	Gentamicin Sponge	Visit 3 Day 7	26	Participants
Number of Participants With a Positive Clinical Response at Each Time Point	Levofloxacin	Visit 3 Day 7	10	Participants
Number of Participants With a Positive Clinical Response at Each Time Point	Gentamicin Sponge	Visit 4 Day 10	25	Participants
Number of Participants With a Positive Clinical Response at Each Time Point	Levofloxacin	Visit 4 Day 10	7	Participants
Number of Participants With a Positive Clinical Response at Each Time Point	Gentamicin Sponge	Visit 5 Day 14	24	Participants
Number of Participants With a Positive Clinical Response at Each Time Point	Levofloxacin	Visit 5 Day 14	6	Participants

1 to 10 of 90Source ClinicalTrials.gov

See all 90 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Gentamicin-collagen Sponge and Levofloxacin	38
Overall Study	STARTED	Levofloxacin	18
Overall Study	COMPLETED	Gentamicin-collagen Sponge and Levofloxacin	23
Overall Study	COMPLETED	Levofloxacin	10
Overall Study	NOT COMPLETED	Gentamicin-collagen Sponge and Levofloxacin	15
Overall Study	NOT COMPLETED	Levofloxacin	8

Source ClinicalTrials.gov

Adverse events16

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	Tinea pedis	Infections and infestations	Gentamicin Sponge	2	38	2
other	Tinea pedis	Infections and infestations	Levofloxacin	0	18	0
other	Blood creatinine increased	Investigations	Gentamicin Sponge	2	38	2
other	Blood creatinine increased	Investigations	Levofloxacin	1	18	1
serious	Cellulitis	Infections and infestations	Gentamicin Sponge	1	38	1
serious	Cellulitis	Infections and infestations	Levofloxacin	0	18	0
serious	Infected skin ulcer	Infections and infestations	Gentamicin Sponge	0	38	0
serious	Infected skin ulcer	Infections and infestations	Levofloxacin	1	18	1
serious	Tendon rupture	Injury, poisoning and procedural complications	Gentamicin Sponge	1	38	1
serious	Tendon rupture	Injury, poisoning and procedural complications	Levofloxacin	0	18	0

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Gentamicin Sponge	0	38
Total, all-cause mortality	Levofloxacin	0	18
Total, other adverse events	Gentamicin Sponge	4	38
Total, other adverse events	Levofloxacin	1	18
Total, serious adverse events	Gentamicin Sponge	5	38
Total, serious adverse events	Levofloxacin	1	18

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22659765	RESULT

Source PubMed

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: Number of Participants With a Clinical Cure at Visit 3 (Day 7)	Trial comparisons
Gentamicin Sponge vs Levofloxacin: deaths from any cause	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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