Trial Outcomes & Findings for Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With a Mild Infection of a Foot Ulcer (NCT NCT00593567)
NCT ID: NCT00593567
Last Updated: 2022-05-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Final Study Visit (Day 21 [or 28 or 35])
Results posted on
2022-05-31
Participant Flow
Participant milestones
| Measure |
Gentamicin Sponge
Daily topical gentamicin sponge and standard daily wound care
gentamicin-collagen sponge: Inserted daily into open ulcer
|
Levofloxacin
Daily oral levofloxacin 750 mg and standard daily wound care
Levofloxacin: 750mg oral levofloxacin daily
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
22
|
|
Overall Study
COMPLETED
|
28
|
12
|
|
Overall Study
NOT COMPLETED
|
20
|
10
|
Reasons for withdrawal
| Measure |
Gentamicin Sponge
Daily topical gentamicin sponge and standard daily wound care
gentamicin-collagen sponge: Inserted daily into open ulcer
|
Levofloxacin
Daily oral levofloxacin 750 mg and standard daily wound care
Levofloxacin: 750mg oral levofloxacin daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Protocol Violation
|
13
|
7
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With a Mild Infection of a Foot Ulcer
Baseline characteristics by cohort
| Measure |
Gentamicin Sponge
n=47 Participants
Daily topical gentamicin sponge and standard daily wound care
gentamicin-collagen sponge: Inserted daily into open ulcer
|
Levofloxacin
n=22 Participants
Daily oral levofloxacin 750 mg and standard daily wound care
Levofloxacin: 750mg oral levofloxacin daily
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.6 Years
STANDARD_DEVIATION 10.54 • n=5 Participants
|
58.9 Years
STANDARD_DEVIATION 14.04 • n=7 Participants
|
59.4 Years
STANDARD_DEVIATION 11.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Final Study Visit (Day 21 [or 28 or 35])Population: Modified Intent-to-Treat Population
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.
Outcome measures
| Measure |
Gentamicin Sponge
n=34 Participants
Daily topical gentamicin sponge and standard daily wound care
gentamicin-collagen sponge: Inserted daily into open ulcer
|
Levofloxacin
n=15 Participants
Daily oral levofloxacin 750 mg and standard daily wound care
Levofloxacin: 750mg oral levofloxacin daily
|
|---|---|---|
|
Number of Participants With a Clinical Outcome of "Clinical Cure"
|
14 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Each time point (Day 3, 7 [14 and 21 if necessary])Population: Modified intent to treat population.
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.
Outcome measures
| Measure |
Gentamicin Sponge
n=34 Participants
Daily topical gentamicin sponge and standard daily wound care
gentamicin-collagen sponge: Inserted daily into open ulcer
|
Levofloxacin
n=15 Participants
Daily oral levofloxacin 750 mg and standard daily wound care
Levofloxacin: 750mg oral levofloxacin daily
|
|---|---|---|
|
Number of Participants With a Clinical Outcome of "Clinical Cure" in Each Treatment Group
Visit 2 Day 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Clinical Outcome of "Clinical Cure" in Each Treatment Group
Visit 3 Day 7
|
4 Participants
|
0 Participants
|
|
Number of Participants With a Clinical Outcome of "Clinical Cure" in Each Treatment Group
Visit 4 Day 14
|
4 Participants
|
6 Participants
|
|
Number of Participants With a Clinical Outcome of "Clinical Cure" in Each Treatment Group
Visit 5 Day 21
|
8 Participants
|
0 Participants
|
|
Number of Participants With a Clinical Outcome of "Clinical Cure" in Each Treatment Group
Final Study Visit
|
14 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: assessed at each time point on days 7, 14, 21, time to pathogen eradication from baseline up to day 21 reportedPopulation: mITT
Outcome measures
| Measure |
Gentamicin Sponge
n=31 Participants
Daily topical gentamicin sponge and standard daily wound care
gentamicin-collagen sponge: Inserted daily into open ulcer
|
Levofloxacin
n=14 Participants
Daily oral levofloxacin 750 mg and standard daily wound care
Levofloxacin: 750mg oral levofloxacin daily
|
|---|---|---|
|
Time to Baseline Pathogen Eradication
|
7.0 Days
Interval 7.0 to 8.0
|
14.5 Days
Interval 7.0 to
Upper boundary not reached
|
SECONDARY outcome
Timeframe: At each timepoint Day 3, 7, 14 & 21Population: mITT
Outcome measures
| Measure |
Gentamicin Sponge
n=34 Participants
Daily topical gentamicin sponge and standard daily wound care
gentamicin-collagen sponge: Inserted daily into open ulcer
|
Levofloxacin
n=15 Participants
Daily oral levofloxacin 750 mg and standard daily wound care
Levofloxacin: 750mg oral levofloxacin daily
|
|---|---|---|
|
Number of Participants With Complete Wound Closure by Each Visit
Visit 2 Day 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Complete Wound Closure by Each Visit
Visit 3 Day 7
|
2 Participants
|
0 Participants
|
|
Number of Participants With Complete Wound Closure by Each Visit
Visit 4 Day 14
|
3 Participants
|
2 Participants
|
|
Number of Participants With Complete Wound Closure by Each Visit
Visit 5 Day 21
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Actual time assessed (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35])Population: Modified ITT
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.
Outcome measures
| Measure |
Gentamicin Sponge
n=34 Participants
Daily topical gentamicin sponge and standard daily wound care
gentamicin-collagen sponge: Inserted daily into open ulcer
|
Levofloxacin
n=15 Participants
Daily oral levofloxacin 750 mg and standard daily wound care
Levofloxacin: 750mg oral levofloxacin daily
|
|---|---|---|
|
Time to Clinical Cure
|
22.0 Days
Interval 21.0 to
17 patients censored
|
NA Days
Interval 14.0 to
8 out of 15 patients censored
|
SECONDARY outcome
Timeframe: Actual time assessed (Day 1-21Population: Micro Modified Intent-to-Treat Population
Time to Baseline Pathogen Eradication summed
Outcome measures
| Measure |
Gentamicin Sponge
n=30 Participants
Daily topical gentamicin sponge and standard daily wound care
gentamicin-collagen sponge: Inserted daily into open ulcer
|
Levofloxacin
n=14 Participants
Daily oral levofloxacin 750 mg and standard daily wound care
Levofloxacin: 750mg oral levofloxacin daily
|
|---|---|---|
|
Time to Pathogen Eradication
|
7.0 Days
Interval 7.0 to 8.0
|
14.5 Days
Interval 7.0 to
not able to calculate high boundary
|
SECONDARY outcome
Timeframe: (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35])Population: mITT
Outcome measures
| Measure |
Gentamicin Sponge
n=34 Participants
Daily topical gentamicin sponge and standard daily wound care
gentamicin-collagen sponge: Inserted daily into open ulcer
|
Levofloxacin
n=15 Participants
Daily oral levofloxacin 750 mg and standard daily wound care
Levofloxacin: 750mg oral levofloxacin daily
|
|---|---|---|
|
Time to Positive Clinical Response
|
2.0 Days
Interval 2.0 to 3.0
|
3.0 Days
Interval 2.0 to 3.0
|
Adverse Events
Gentamicin Sponge
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Levofloxacin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gentamicin Sponge
n=47 participants at risk
Daily topical gentamicin sponge and standard daily wound care
gentamicin-collagen sponge: Inserted daily into open ulcer
|
Levofloxacin
n=22 participants at risk
Daily oral levofloxacin 750 mg and standard daily wound care
Levofloxacin: 750mg oral levofloxacin daily
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
2/47 • Number of events 2 • about 35 days.
|
4.5%
1/22 • Number of events 1 • about 35 days.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
4.5%
1/22 • Number of events 1 • about 35 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/47 • about 35 days.
|
4.5%
1/22 • Number of events 1 • about 35 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/47 • about 35 days.
|
4.5%
1/22 • Number of events 1 • about 35 days.
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/47 • about 35 days.
|
4.5%
1/22 • Number of events 1 • about 35 days.
|
|
Gastrointestinal disorders
Toothache
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
General disorders
Chills
|
4.3%
2/47 • Number of events 2 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
General disorders
Odema peripheral
|
0.00%
0/47 • about 35 days.
|
4.5%
1/22 • Number of events 1 • about 35 days.
|
|
General disorders
Pitting oedema
|
0.00%
0/47 • about 35 days.
|
4.5%
1/22 • Number of events 1 • about 35 days.
|
|
Infections and infestations
Naspoharygitis
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
9.1%
2/22 • Number of events 2 • about 35 days.
|
|
Infections and infestations
Bacterial infections
|
0.00%
0/47 • about 35 days.
|
4.5%
1/22 • Number of events 1 • about 35 days.
|
|
Infections and infestations
Cellulitis
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
Infections and infestations
Urinary Tract infections
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
Injury, poisoning and procedural complications
Excoriatiosn
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
Injury, poisoning and procedural complications
Fall
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
Injury, poisoning and procedural complications
Skin lacerations
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
Injury, poisoning and procedural complications
Would complication
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
Investigations
Neutrophil count decreased
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
Investigations
Red blood cell urine positive
|
0.00%
0/47 • about 35 days.
|
4.5%
1/22 • Number of events 1 • about 35 days.
|
|
Investigations
white blood cell count decreased
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
Investigations
white blood cells urine positive
|
0.00%
0/47 • about 35 days.
|
4.5%
1/22 • Number of events 1 • about 35 days.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
4.5%
1/22 • Number of events 1 • about 35 days.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/47 • about 35 days.
|
4.5%
1/22 • Number of events 1 • about 35 days.
|
|
Nervous system disorders
Dizziness
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
Nervous system disorders
Headache
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
Nervous system disorders
Transient
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
Psychiatric disorders
Insomnia
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.1%
1/47 • Number of events 1 • about 35 days.
|
0.00%
0/22 • about 35 days.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/47 • about 35 days.
|
4.5%
1/22 • Number of events 1 • about 35 days.
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
0.00%
0/47 • about 35 days.
|
4.5%
1/22 • Number of events 1 • about 35 days.
|
Additional Information
Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management
Innocoll
Phone: 484-406-5211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place