Trial Outcomes & Findings for The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers (NCT NCT00659646)
NCT ID: NCT00659646
Last Updated: 2022-01-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Day 7 of treatment
Results posted on
2022-01-27
Participant Flow
Investigative medical sites
Participant milestones
| Measure |
Gentamicin-collagen Sponge and Levofloxacin
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.
|
Levofloxacin
Levofloxacin only: levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
18
|
|
Overall Study
COMPLETED
|
23
|
10
|
|
Overall Study
NOT COMPLETED
|
15
|
8
|
Reasons for withdrawal
| Measure |
Gentamicin-collagen Sponge and Levofloxacin
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.
|
Levofloxacin
Levofloxacin only: levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours
|
|---|---|---|
|
Overall Study
Protocol Violation
|
12
|
8
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
protocol noncompliance after randomized
|
1
|
0
|
Baseline Characteristics
The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers
Baseline characteristics by cohort
| Measure |
Gentamicin Sponge
n=26 Participants
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.
|
Levofloxacin
n=10 Participants
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
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 9.17 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7 of treatmentPopulation: modified intent-to-treat
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.
Outcome measures
| Measure |
Gentamicin Sponge
n=26 Participants
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.
|
Levofloxacin
n=10 Participants
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
|
|---|---|---|
|
Number of Participants With a Clinical Cure at Visit 3 (Day 7)
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 3, 7, 10,14, 21, 28 and 42Number 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
Outcome measures
| Measure |
Gentamicin Sponge
n=26 Participants
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.
|
Levofloxacin
n=10 Participants
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
|
|---|---|---|
|
Number of Participants With a Positive Clinical Response at Each Time Point
Visit 2 Day 3
|
24 Participants
|
9 Participants
|
|
Number of Participants With a Positive Clinical Response at Each Time Point
Visit 3 Day 7
|
26 Participants
|
10 Participants
|
|
Number of Participants With a Positive Clinical Response at Each Time Point
Visit 4 Day 10
|
25 Participants
|
7 Participants
|
|
Number of Participants With a Positive Clinical Response at Each Time Point
Visit 5 Day 14
|
24 Participants
|
6 Participants
|
|
Number of Participants With a Positive Clinical Response at Each Time Point
Visit 6 Day 21
|
14 Participants
|
3 Participants
|
|
Number of Participants With a Positive Clinical Response at Each Time Point
Visit 7 Day 28
|
10 Participants
|
3 Participants
|
|
Number of Participants With a Positive Clinical Response at Each Time Point
Final Study Visit Day 42
|
22 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day 3, 10, 14, 21, 28 & 42Population: mITT
clinical cure is defined as having a positive clinical response and with pathogen eradication
Outcome measures
| Measure |
Gentamicin Sponge
n=26 Participants
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.
|
Levofloxacin
n=10 Participants
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
|
|---|---|---|
|
Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7)
Visit 4 Day 10
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7)
Visit 2 Day 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7)
Visit 5 Day 14
|
10 Participants
|
3 Participants
|
|
Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7)
Visit 6 Day 21
|
4 Participants
|
0 Participants
|
|
Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7)
Visit 7 Day 28
|
9 Participants
|
1 Participants
|
|
Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7)
Final Visit Day 42
|
22 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 3, 7, 10, 14, 21 & 28Population: mITT
Outcome measures
| Measure |
Gentamicin Sponge
n=26 Participants
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.
|
Levofloxacin
n=8 Participants
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
|
|---|---|---|
|
Number of Participants With Pathogen Eradication by Visit
Visit 2 Day 3
|
20 Participants
|
1 Participants
|
|
Number of Participants With Pathogen Eradication by Visit
Visit 3 Day 7
|
24 Participants
|
2 Participants
|
|
Number of Participants With Pathogen Eradication by Visit
Visit 4 Day 10
|
23 Participants
|
2 Participants
|
|
Number of Participants With Pathogen Eradication by Visit
Visit 5 Day 14
|
18 Participants
|
2 Participants
|
|
Number of Participants With Pathogen Eradication by Visit
Visit 6 Day 21
|
12 Participants
|
0 Participants
|
|
Number of Participants With Pathogen Eradication by Visit
Visit 7 Day 28
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 3, 7, 10, 14, 21, 28 & 42Population: mITT
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.
Outcome measures
| Measure |
Gentamicin Sponge
n=26 Participants
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.
|
Levofloxacin
n=10 Participants
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
|
|---|---|---|
|
Change From Baseline in Total Wound Surface Area Measured in cm^2
Visit 1 Day 1
|
5.11 cm^2
Standard Deviation 9.249
|
1.24 cm^2
Standard Deviation 0.998
|
|
Change From Baseline in Total Wound Surface Area Measured in cm^2
Visit 2 Day 3
|
4.50 cm^2
Standard Deviation 8.53
|
.92 cm^2
Standard Deviation .78
|
|
Change From Baseline in Total Wound Surface Area Measured in cm^2
Visit 3 Day 7
|
4.47 cm^2
Standard Deviation 8.19
|
.76 cm^2
Standard Deviation .707
|
|
Change From Baseline in Total Wound Surface Area Measured in cm^2
Visit 4 Day 10
|
4.31 cm^2
Standard Deviation 8.730
|
1.14 cm^2
Standard Deviation 0.760
|
|
Change From Baseline in Total Wound Surface Area Measured in cm^2
Visit 5 Day 14
|
4.14 cm^2
Standard Deviation 9.041
|
0.95 cm^2
Standard Deviation .656
|
|
Change From Baseline in Total Wound Surface Area Measured in cm^2
Visit 6 Day 21
|
2.93 cm^2
Standard Deviation 5.517
|
1 cm^2
Standard Deviation 0.671
|
|
Change From Baseline in Total Wound Surface Area Measured in cm^2
Visit 7 Day 28
|
2.67 cm^2
Standard Deviation 5.474
|
.93 cm^2
Standard Deviation 0.606
|
|
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
|
.64 cm^2
Standard Deviation .846
|
SECONDARY outcome
Timeframe: Days 1 through 49Population: mITT
clinical cure is defined as having a positive clinical response and with pathogen eradication
Outcome measures
| Measure |
Gentamicin Sponge
n=26 Participants
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.
|
Levofloxacin
n=10 Participants
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
|
|---|---|---|
|
Time to Clinical Cure
|
21 Days
Interval 14.0 to 28.0
|
14 Days
Interval 7.0 to 40.0
|
SECONDARY outcome
Timeframe: Day 3, 7, 10, 14, 21, 28 & 42Measured 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.
Outcome measures
| Measure |
Gentamicin Sponge
n=26 Participants
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.
|
Levofloxacin
n=10 Participants
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
|
|---|---|---|
|
Visual Analog Scale (VAS) for Pain Assessment
Visit 1 Day 1
|
39.2 score on a scale*days
Standard Deviation 36.79
|
26.3 score on a scale*days
Standard Deviation 21.77
|
|
Visual Analog Scale (VAS) for Pain Assessment
Visit 2 Day 3
|
27.6 score on a scale*days
Standard Deviation 32.22
|
18.7 score on a scale*days
Standard Deviation 19.60
|
|
Visual Analog Scale (VAS) for Pain Assessment
Visit 3 Day 7
|
17.5 score on a scale*days
Standard Deviation 23.58
|
12.6 score on a scale*days
Standard Deviation 19.67
|
|
Visual Analog Scale (VAS) for Pain Assessment
Visit 4 Day 10
|
17.2 score on a scale*days
Standard Deviation 23.34
|
13.6 score on a scale*days
Standard Deviation 20.98
|
|
Visual Analog Scale (VAS) for Pain Assessment
Visit 5 Day 14
|
13.3 score on a scale*days
Standard Deviation 20.99
|
13.2 score on a scale*days
Standard Deviation 21.45
|
|
Visual Analog Scale (VAS) for Pain Assessment
Visit 6 Day 21
|
22.9 score on a scale*days
Standard Deviation 34.20
|
14.3 score on a scale*days
Standard Deviation 22.28
|
|
Visual Analog Scale (VAS) for Pain Assessment
Visit 7 Day 28
|
14.3 score on a scale*days
Standard Deviation 30.96
|
9.3 score on a scale*days
Standard Deviation 10.07
|
|
Visual Analog Scale (VAS) for Pain Assessment
Final Study Visit Day42
|
17.3 score on a scale*days
Standard Deviation 28.84
|
2.3 score on a scale*days
Standard Deviation 28.84
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 21, 28, 42The 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".
Outcome measures
| Measure |
Gentamicin Sponge
n=24 Participants
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.
|
Levofloxacin
n=10 Participants
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
|
|---|---|---|
|
Lipsky Wound Score
Final Study Visit Day 42
|
6.18 score on a scale
Standard Deviation 4.239
|
4.80 score on a scale
Standard Deviation 2.251
|
|
Lipsky Wound Score
Visit 1 Day 1
|
17.67 score on a scale
Standard Deviation 4.498
|
13.10 score on a scale
Standard Deviation 5.043
|
|
Lipsky Wound Score
Visit 2 Day 3
|
13.58 score on a scale
Standard Deviation 4.373
|
11 score on a scale
Standard Deviation 3.771
|
|
Lipsky Wound Score
Visit 3 Day 7
|
10.79 score on a scale
Standard Deviation 4.364
|
7.60 score on a scale
Standard Deviation 4.300
|
|
Lipsky Wound Score
Visit 4 Day 10
|
9.17 score on a scale
Standard Deviation 4.108
|
8.29 score on a scale
Standard Deviation 3.147
|
|
Lipsky Wound Score
Visit 5 Day 14
|
8.36 score on a scale
Standard Deviation 4.315
|
5.33 score on a scale
Standard Deviation 1.633
|
|
Lipsky Wound Score
Visit 6 Day 21
|
7.29 score on a scale
Standard Deviation 3.970
|
4.33 score on a scale
Standard Deviation 2.309
|
|
Lipsky Wound Score
Visit 7 Day 28
|
5.10 score on a scale
Standard Deviation 2.87
|
3.67 score on a scale
Standard Deviation 1.155
|
Adverse Events
Gentamicin Sponge
Serious events: 5 serious events
Other events: 4 other events
Deaths: 0 deaths
Levofloxacin
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gentamicin Sponge
n=38 participants at risk
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.
|
Levofloxacin
n=18 participants at risk
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
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
2.6%
1/38 • Number of events 1 • Day 42
|
0.00%
0/18 • Day 42
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/38 • Day 42
|
5.6%
1/18 • Number of events 1 • Day 42
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
2.6%
1/38 • Number of events 1 • Day 42
|
0.00%
0/18 • Day 42
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.6%
1/38 • Number of events 1 • Day 42
|
0.00%
0/18 • Day 42
|
|
Renal and urinary disorders
Renal failure
|
2.6%
1/38 • Number of events 1 • Day 42
|
0.00%
0/18 • Day 42
|
|
Vascular disorders
Wound haemorrhage
|
2.6%
1/38 • Number of events 1 • Day 42
|
0.00%
0/18 • Day 42
|
Other adverse events
| Measure |
Gentamicin Sponge
n=38 participants at risk
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.
|
Levofloxacin
n=18 participants at risk
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
|
|---|---|---|
|
Infections and infestations
Tinea pedis
|
5.3%
2/38 • Number of events 2 • Day 42
|
0.00%
0/18 • Day 42
|
|
Investigations
Blood creatinine increased
|
5.3%
2/38 • Number of events 2 • Day 42
|
5.6%
1/18 • Number of events 1 • Day 42
|
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
Restriction type: OTHER