Diabetic Foot Ulcer
Conditions
Keywords
Diabetes, ulcers, ulcerations, infection
Brief summary
The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard daily wound care and an oral antibiotic (levofloxacin) is safe and effective in treating moderately infected skin ulcers compared to treatment only with standard daily wound care and an oral antibiotic (levofloxacin).
Detailed description
Infected skin ulcers with diabetes can be very debilitating because they are difficult to heal. Diabetic ulcers are responsible for frequent health care visits, and are a major predictor of amputation. Diabetic ulcers can be caused by a patient's inability to sense pain or warmth as well as peripheral vascular disease, which causes diminished blood flow to the foot. Early aggressive treatment is necessary to treat infection and ultimately prevent the need for amputation. Gentamicin is an antibiotic that is effective in treating certain kinds of infection. Collagen is a protein that is found in all mammals. The gentamicin-collagen sponge is a thin flat sponge made out of collagen that comes from cow tendons and containing gentamicin. When applied to an open ulcer, the collagen breaks down and the gentamicin is released into the ulcer, but very little is absorbed into the blood stream. The high levels of gentamicin in the open infected ulcer may help treat the infection. In this study, all subjects will be given the necessary supplies and taught how to take care their foot ulcer. All subjects will also receive oral an antibiotic (levofloxacin). Additionally, subjects who are randomly assigned to receive the gentamicin-collagen sponge will place a gentamicin-collagen sponge on their ulcer during daily wound care.
Interventions
DRUGgentamicin-collagen sponge and levofloxacin
Topical Gentamicin Collagen Sponge: 10 × 10 cm in size And 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours.
DRUGLevofloxacin only
levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours
Sponsors
Premier Research
Innocoll
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Is a man or woman aged ≥ 18 and ≤ 80 years. * Has diabetes mellitus, according to the American Diabetes Association criteria. * Has a single infected skin ulcer below the knee, defined as moderate by the Infectious Disease Society of America (IDSA) Guidelines for whom, in the Investigator's opinion, intravenous (IV) or oral antimicrobial therapy is appropriate * Has had an x ray of the infected area within the 2 days immediately preceding or at Visit 1 (Baseline/Randomization) to document the presence or absence of osteomyelitis. Patients with osteomyelitis must receive appropriate surgical intervention to remove all necrotic and infected bone and otherwise meet enrollment criteria before being enrolled in the study. * Meets certain minimal laboratory criteria * Has an ankle brachial index (ABI) \> or = 0.7 and ≤ 1.3. (Note: Patients with ABI \< 0.7 or \> 1.3 may be included if they have either a transcutaneous oxygen pressure or a toe pressure \> or = 40 mm Hg on limb with ulcer.) * If female, is nonpregnant (negative pregnancy test results at the Baseline/Randomization Visit) and nonlactating. * If female, is either not of childbearing potential (defined as postmenopausal for ≥ 1 year or surgically sterile \[bilateral tubal ligation, bilateral oophorectomy or hysterectomy\]) or practicing a medically acceptable methods of birth control and agrees to continue with the regimen throughout the study * Willing to return to the study facility for the Final Study Visit. * Must be able to fluently speak and understand English and be able to provide meaningful written informed consent for the study.
Exclusion criteria
* Has a known history of hypersensitivity to gentamicin (or other systemic aminoglycosides) or levofloxacin or drugs in the same class, or any of the test article or reference product components. * Has a known hypersensitivity to bovine collagen. * Has any uncontrolled illnesses that, in the opinion of the Investigator, would interfere with interpreting the results of the study. * Has a target ulcer with a wound size \> 10 × 10 cm. * Has gangrenous tissue of the affected limb that cannot be removed with a single debridement. * Has wound known to contain isolates resistant to levofloxacin. * Has a wound associated with prosthetic material or device. * Received any topical or systemic antimicrobial therapy within the 2 weeks prior to study entry (Visit 1 \[Day 1\]). * If severely immunocompromised, may be excluded at the discretion of the Investigator. * Has a history of alcohol or substance abuse in the past 12 months. * Has serum creatinine \> 3 mg/dL, is undergoing dialysis (renal or peritoneal) or has a history of kidney transplant. * Has a history of myasthenia gravis or other neurological condition where gentamicin use is contraindicated as determined by the Investigator. * Has a history of epilepsy * Has a history of tendon disorders related to fluoroquinolone administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Number of Participants With Pathogen Eradication by Visit | Day 3, 7, 10, 14, 21 & 28 | — |
| 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. |
| 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 |
| 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. |
| 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. |
| Time to Clinical Cure | Days 1 through 49 | clinical cure is defined as having a positive clinical response and with pathogen eradication |
Countries
United States
Participant flow
Recruitment details
Investigative medical sites
Participants by arm
| Arm | Count |
|---|---|
| Gentamicin Sponge Gentamicin sponge applied into wound plus levofloxacin, 750 mg by mouth (po) or intravenous (IV) every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing
gentamicin-collagen sponge and levofloxacin: Topical Gentamicin Collagen Sponge: 10 × 10 cm in size And 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours. | 26 |
| Levofloxacin Levofloxacin, 750 mg po or IV every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing
Levofloxacin only: levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours | 10 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | protocol noncompliance after randomized | 1 | 0 |
| Overall Study | Protocol Violation | 12 | 8 |
Baseline characteristics
| Characteristic | Gentamicin Sponge | Levofloxacin | Total |
|---|---|---|---|
| Age, Continuous | 61.1 years STANDARD_DEVIATION 9.17 | 55.1 years STANDARD_DEVIATION 14.3 | 59.4 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment United States | 26 Participants | 10 Participants | 36 Participants |
| Sex: Female, Male Female | 9 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Male | 17 Participants | 8 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 18 |
| other Total, other adverse events | 4 / 38 | 1 / 18 |
| serious Total, serious adverse events | 5 / 38 | 1 / 18 |
Outcome results
Primary
Number of Participants With a Clinical Cure at Visit 3 (Day 7)
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.
Time frame: Day 7 of treatment
Population: modified intent-to-treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gentamicin Sponge | Number of Participants With a Clinical Cure at Visit 3 (Day 7) | 0 Participants |
| Levofloxacin | Number of Participants With a Clinical Cure at Visit 3 (Day 7) | 3 Participants |
Secondary
Change From Baseline in Total Wound Surface Area Measured in cm^2
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.
Time frame: Day 3, 7, 10, 14, 21, 28 & 42
Population: mITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gentamicin Sponge | Change From Baseline in Total Wound Surface Area Measured in cm^2 | Visit 2 Day 3 | 4.50 cm^2 | Standard Deviation 8.53 |
| Gentamicin Sponge | Change From Baseline in Total Wound Surface Area Measured in cm^2 | Visit 7 Day 28 | 2.67 cm^2 | Standard Deviation 5.474 |
| Gentamicin Sponge | Change From Baseline in Total Wound Surface Area Measured in cm^2 | Final Study Visit Day 42 | 3.73 cm^2 | Standard Deviation 9.047 |
| Gentamicin Sponge | Change From Baseline in Total Wound Surface Area Measured in cm^2 | Visit 4 Day 10 | 4.31 cm^2 | Standard Deviation 8.73 |
| Gentamicin Sponge | Change From Baseline in Total Wound Surface Area Measured in cm^2 | Visit 6 Day 21 | 2.93 cm^2 | Standard Deviation 5.517 |
| Gentamicin Sponge | Change From Baseline in Total Wound Surface Area Measured in cm^2 | Visit 3 Day 7 | 4.47 cm^2 | Standard Deviation 8.19 |
| Gentamicin Sponge | Change From Baseline in Total Wound Surface Area Measured in cm^2 | Visit 5 Day 14 | 4.14 cm^2 | Standard Deviation 9.041 |
| Gentamicin Sponge | Change From Baseline in Total Wound Surface Area Measured in cm^2 | Visit 1 Day 1 | 5.11 cm^2 | Standard Deviation 9.249 |
| Levofloxacin | Change From Baseline in Total Wound Surface Area Measured in cm^2 | Visit 7 Day 28 | .93 cm^2 | Standard Deviation 0.606 |
| Levofloxacin | Change From Baseline in Total Wound Surface Area Measured in cm^2 | Visit 1 Day 1 | 1.24 cm^2 | Standard Deviation 0.998 |
| Levofloxacin | Change From Baseline in Total Wound Surface Area Measured in cm^2 | Visit 3 Day 7 | .76 cm^2 | Standard Deviation 0.707 |
| Levofloxacin | Change From Baseline in Total Wound Surface Area Measured in cm^2 | Visit 4 Day 10 | 1.14 cm^2 | Standard Deviation 0.76 |
| Levofloxacin | Change From Baseline in Total Wound Surface Area Measured in cm^2 | Visit 5 Day 14 | 0.95 cm^2 | Standard Deviation 0.656 |
| Levofloxacin | Change From Baseline in Total Wound Surface Area Measured in cm^2 | Visit 6 Day 21 | 1 cm^2 | Standard Deviation 0.671 |
| Levofloxacin | Change From Baseline in Total Wound Surface Area Measured in cm^2 | Final Study Visit Day 42 | .64 cm^2 | Standard Deviation 0.846 |
| Levofloxacin | Change From Baseline in Total Wound Surface Area Measured in cm^2 | Visit 2 Day 3 | .92 cm^2 | Standard Deviation 0.78 |
Secondary
Lipsky Wound Score
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.
Time frame: Days 3, 7, 10, 14, 21, 28, 42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gentamicin Sponge | Lipsky Wound Score | Visit 1 Day 1 | 17.67 score on a scale | Standard Deviation 4.498 |
| Gentamicin Sponge | Lipsky Wound Score | Visit 5 Day 14 | 8.36 score on a scale | Standard Deviation 4.315 |
| Gentamicin Sponge | Lipsky Wound Score | Visit 2 Day 3 | 13.58 score on a scale | Standard Deviation 4.373 |
| Gentamicin Sponge | Lipsky Wound Score | Visit 3 Day 7 | 10.79 score on a scale | Standard Deviation 4.364 |
| Gentamicin Sponge | Lipsky Wound Score | Visit 4 Day 10 | 9.17 score on a scale | Standard Deviation 4.108 |
| Gentamicin Sponge | Lipsky Wound Score | Visit 6 Day 21 | 7.29 score on a scale | Standard Deviation 3.97 |
| Gentamicin Sponge | Lipsky Wound Score | Visit 7 Day 28 | 5.10 score on a scale | Standard Deviation 2.87 |
| Gentamicin Sponge | Lipsky Wound Score | Final Study Visit Day 42 | 6.18 score on a scale | Standard Deviation 4.239 |
| Levofloxacin | Lipsky Wound Score | Final Study Visit Day 42 | 4.80 score on a scale | Standard Deviation 2.251 |
| Levofloxacin | Lipsky Wound Score | Visit 4 Day 10 | 8.29 score on a scale | Standard Deviation 3.147 |
| Levofloxacin | Lipsky Wound Score | Visit 3 Day 7 | 7.60 score on a scale | Standard Deviation 4.3 |
| Levofloxacin | Lipsky Wound Score | Visit 5 Day 14 | 5.33 score on a scale | Standard Deviation 1.633 |
| Levofloxacin | Lipsky Wound Score | Visit 7 Day 28 | 3.67 score on a scale | Standard Deviation 1.155 |
| Levofloxacin | Lipsky Wound Score | Visit 1 Day 1 | 13.10 score on a scale | Standard Deviation 5.043 |
| Levofloxacin | Lipsky Wound Score | Visit 6 Day 21 | 4.33 score on a scale | Standard Deviation 2.309 |
| Levofloxacin | Lipsky Wound Score | Visit 2 Day 3 | 11 score on a scale | Standard Deviation 3.771 |
Secondary
Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7)
clinical cure is defined as having a positive clinical response and with pathogen eradication
Time frame: Day 3, 10, 14, 21, 28 & 42
Population: mITT
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gentamicin Sponge | Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7) | Visit 5 Day 14 | 10 Participants |
| Gentamicin Sponge | Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7) | Visit 6 Day 21 | 4 Participants |
| Gentamicin Sponge | Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7) | Final Visit Day 42 | 22 Participants |
| Gentamicin Sponge | Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7) | Visit 2 Day 3 | 0 Participants |
| Gentamicin Sponge | Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7) | Visit 4 Day 10 | 1 Participants |
| Gentamicin Sponge | Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7) | Visit 7 Day 28 | 9 Participants |
| Levofloxacin | Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7) | Visit 7 Day 28 | 1 Participants |
| Levofloxacin | Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7) | Visit 5 Day 14 | 3 Participants |
| Levofloxacin | Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7) | Visit 4 Day 10 | 0 Participants |
| Levofloxacin | Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7) | Visit 6 Day 21 | 0 Participants |
| Levofloxacin | Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7) | Final Visit Day 42 | 7 Participants |
| Levofloxacin | Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7) | Visit 2 Day 3 | 0 Participants |
Secondary
Number of Participants With a Positive Clinical Response at Each Time Point
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
Time frame: Day 3, 7, 10,14, 21, 28 and 42
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gentamicin Sponge | Number of Participants With a Positive Clinical Response at Each Time Point | Final Study Visit Day 42 | 22 Participants |
| Gentamicin Sponge | Number of Participants With a Positive Clinical Response at Each Time Point | Visit 2 Day 3 | 24 Participants |
| Gentamicin Sponge | Number of Participants With a Positive Clinical Response at Each Time Point | Visit 4 Day 10 | 25 Participants |
| Gentamicin Sponge | Number of Participants With a Positive Clinical Response at Each Time Point | Visit 3 Day 7 | 26 Participants |
| Gentamicin Sponge | Number of Participants With a Positive Clinical Response at Each Time Point | Visit 6 Day 21 | 14 Participants |
| Gentamicin Sponge | Number of Participants With a Positive Clinical Response at Each Time Point | Visit 7 Day 28 | 10 Participants |
| Gentamicin Sponge | Number of Participants With a Positive Clinical Response at Each Time Point | Visit 5 Day 14 | 24 Participants |
| Levofloxacin | Number of Participants With a Positive Clinical Response at Each Time Point | Final Study Visit Day 42 | 10 Participants |
| Levofloxacin | Number of Participants With a Positive Clinical Response at Each Time Point | Visit 4 Day 10 | 7 Participants |
| Levofloxacin | Number of Participants With a Positive Clinical Response at Each Time Point | Visit 5 Day 14 | 6 Participants |
| Levofloxacin | Number of Participants With a Positive Clinical Response at Each Time Point | Visit 7 Day 28 | 3 Participants |
| Levofloxacin | Number of Participants With a Positive Clinical Response at Each Time Point | Visit 2 Day 3 | 9 Participants |
| Levofloxacin | Number of Participants With a Positive Clinical Response at Each Time Point | Visit 6 Day 21 | 3 Participants |
| Levofloxacin | Number of Participants With a Positive Clinical Response at Each Time Point | Visit 3 Day 7 | 10 Participants |
Secondary
Number of Participants With Pathogen Eradication by Visit
Time frame: Day 3, 7, 10, 14, 21 & 28
Population: mITT
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gentamicin Sponge | Number of Participants With Pathogen Eradication by Visit | Visit 2 Day 3 | 20 Participants |
| Gentamicin Sponge | Number of Participants With Pathogen Eradication by Visit | Visit 7 Day 28 | 5 Participants |
| Gentamicin Sponge | Number of Participants With Pathogen Eradication by Visit | Visit 3 Day 7 | 24 Participants |
| Gentamicin Sponge | Number of Participants With Pathogen Eradication by Visit | Visit 4 Day 10 | 23 Participants |
| Gentamicin Sponge | Number of Participants With Pathogen Eradication by Visit | Visit 5 Day 14 | 18 Participants |
| Gentamicin Sponge | Number of Participants With Pathogen Eradication by Visit | Visit 6 Day 21 | 12 Participants |
| Levofloxacin | Number of Participants With Pathogen Eradication by Visit | Visit 5 Day 14 | 2 Participants |
| Levofloxacin | Number of Participants With Pathogen Eradication by Visit | Visit 4 Day 10 | 2 Participants |
| Levofloxacin | Number of Participants With Pathogen Eradication by Visit | Visit 7 Day 28 | 0 Participants |
| Levofloxacin | Number of Participants With Pathogen Eradication by Visit | Visit 2 Day 3 | 1 Participants |
| Levofloxacin | Number of Participants With Pathogen Eradication by Visit | Visit 6 Day 21 | 0 Participants |
| Levofloxacin | Number of Participants With Pathogen Eradication by Visit | Visit 3 Day 7 | 2 Participants |
Secondary
Time to Clinical Cure
clinical cure is defined as having a positive clinical response and with pathogen eradication
Time frame: Days 1 through 49
Population: mITT
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gentamicin Sponge | Time to Clinical Cure | 21 Days |
| Levofloxacin | Time to Clinical Cure | 14 Days |
Secondary
Visual Analog Scale (VAS) for Pain Assessment
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.
Time frame: Day 3, 7, 10, 14, 21, 28 & 42
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gentamicin Sponge | Visual Analog Scale (VAS) for Pain Assessment | Visit 2 Day 3 | 27.6 score on a scale*days | Standard Deviation 32.22 |
| Gentamicin Sponge | Visual Analog Scale (VAS) for Pain Assessment | Visit 4 Day 10 | 17.2 score on a scale*days | Standard Deviation 23.34 |
| Gentamicin Sponge | Visual Analog Scale (VAS) for Pain Assessment | Visit 6 Day 21 | 22.9 score on a scale*days | Standard Deviation 34.2 |
| Gentamicin Sponge | Visual Analog Scale (VAS) for Pain Assessment | Visit 7 Day 28 | 14.3 score on a scale*days | Standard Deviation 30.96 |
| Gentamicin Sponge | Visual Analog Scale (VAS) for Pain Assessment | Final Study Visit Day42 | 17.3 score on a scale*days | Standard Deviation 28.84 |
| Gentamicin Sponge | Visual Analog Scale (VAS) for Pain Assessment | Visit 1 Day 1 | 39.2 score on a scale*days | Standard Deviation 36.79 |
| Gentamicin Sponge | Visual Analog Scale (VAS) for Pain Assessment | Visit 3 Day 7 | 17.5 score on a scale*days | Standard Deviation 23.58 |
| Gentamicin Sponge | Visual Analog Scale (VAS) for Pain Assessment | Visit 5 Day 14 | 13.3 score on a scale*days | Standard Deviation 20.99 |
| Levofloxacin | Visual Analog Scale (VAS) for Pain Assessment | Final Study Visit Day42 | 2.3 score on a scale*days | Standard Deviation 28.84 |
| Levofloxacin | Visual Analog Scale (VAS) for Pain Assessment | Visit 1 Day 1 | 26.3 score on a scale*days | Standard Deviation 21.77 |
| Levofloxacin | Visual Analog Scale (VAS) for Pain Assessment | Visit 4 Day 10 | 13.6 score on a scale*days | Standard Deviation 20.98 |
| Levofloxacin | Visual Analog Scale (VAS) for Pain Assessment | Visit 2 Day 3 | 18.7 score on a scale*days | Standard Deviation 19.6 |
| Levofloxacin | Visual Analog Scale (VAS) for Pain Assessment | Visit 6 Day 21 | 14.3 score on a scale*days | Standard Deviation 22.28 |
| Levofloxacin | Visual Analog Scale (VAS) for Pain Assessment | Visit 5 Day 14 | 13.2 score on a scale*days | Standard Deviation 21.45 |
| Levofloxacin | Visual Analog Scale (VAS) for Pain Assessment | Visit 7 Day 28 | 9.3 score on a scale*days | Standard Deviation 10.07 |
| Levofloxacin | Visual Analog Scale (VAS) for Pain Assessment | Visit 3 Day 7 | 12.6 score on a scale*days | Standard Deviation 19.67 |