Trial Outcomes & Findings for A RCT to Compare the Effects of Two Wound Products on Biofilm Disruption in DFUs (NCT NCT02181621)
NCT ID: NCT02181621
Last Updated: 2024-02-29
Results Overview
The primary variable was the within-patient change from Baseline in log\^10 biofilm-protected bacteria count from Baseline (initial assessment) to Week 4, as measured by curettage.
TERMINATED
NA
19 participants
Baseline to Week 4
2024-02-29
Participant Flow
Initial assessment screening/enrollment occurred at a single site in the United States from 05Aug2014 to 11Sep2015. Eligible participants were randomized to receive either IODOSORB or SOLOSITE for up to 4 weeks (28 +/- 4 days) or until reference ulcer closure (whichever came first).
Participant milestones
| Measure |
SOLOSITE
Hydrogel with preservatives, used to create a moist wound environment.
SOLOSITE Gel: Hydrogel
|
IODOSORB
Cadexomer iodine gel
IODOSORB: Cadexomer iodine gel
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
Week 1 Assessment
|
7
|
8
|
|
Overall Study
Week 2 Assessment
|
6
|
8
|
|
Overall Study
Week 3 Assessment
|
6
|
7
|
|
Overall Study
Week 4 Assessment
|
6
|
7
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
SOLOSITE
Hydrogel with preservatives, used to create a moist wound environment.
SOLOSITE Gel: Hydrogel
|
IODOSORB
Cadexomer iodine gel
IODOSORB: Cadexomer iodine gel
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Previously Enrolled
|
0
|
1
|
|
Overall Study
Enrollment Hold
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SOLOSITE Gel
n=7 Participants
Hydrogel with preservatives, used to create a moist wound environment.
SOLOSITE Gel: Hydrogel
|
IODOSORB
n=7 Participants
Cadexomer iodine gel
IODOSORB: Cadexomer iodine gel
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
51.4 years
STANDARD_DEVIATION 9 • n=7 Participants
|
57 years
STANDARD_DEVIATION 10.2 • n=14 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=14 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
7 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=14 Participants
|
|
Height (centimeters [cm])
|
178.9 cm
STANDARD_DEVIATION 12.6 • n=7 Participants
|
179.9 cm
STANDARD_DEVIATION 9.9 • n=7 Participants
|
179.4 cm
STANDARD_DEVIATION 10.9 • n=14 Participants
|
|
Weight (kilograms [kg])
|
91.9 kg
STANDARD_DEVIATION 31.5 • n=7 Participants
|
114.5 kg
STANDARD_DEVIATION 37.8 • n=7 Participants
|
103.2 kg
STANDARD_DEVIATION 35.5 • n=14 Participants
|
|
Baseline Reference Ulcer: Area (centimeters squared [cm^2])
|
9.4 cm^2
n=7 Participants
|
8.5 cm^2
n=7 Participants
|
9 cm^2
n=14 Participants
|
|
Baseline Reference Ulcer: Depth (millimeters [mm])
|
4 mm
n=7 Participants
|
2 mm
n=7 Participants
|
3 mm
n=14 Participants
|
|
Reference Ulcer: Volume (centimeters cubed [cm^3])
|
3.8 cm^3
n=7 Participants
|
1.7 cm^3
n=7 Participants
|
2.3 cm^3
n=14 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: The reporting of this outcome measure is based on the confirmed biofilm analysis set, defined as all subjects admitted to the study and for which the presence of biofilm was confirmed using curettage samples. Week 4 data were included for a total of 12 subjects (SOLOSITE N= 6; IODOSORB N = 6) in the biofilm analysis set.
The primary variable was the within-patient change from Baseline in log\^10 biofilm-protected bacteria count from Baseline (initial assessment) to Week 4, as measured by curettage.
Outcome measures
| Measure |
Solosite Gel
n=6 Participants
Hydrogel with preservatives, used to create a moist wound environment.
Solosite gel: Hydrogel
|
Iodosorb
n=6 Participants
Cadexomer iodine gel
Iodosorb: Cadexomer iodine gel
|
|---|---|---|
|
Within-patient Change From Baseline in Log^10 Biofilm-protected Bacteria Count (Colony Forming Units [Cfu]/Gram[g])
|
0.8 log^10 CFU/g
Interval -1.1 to 3.5
|
1.0 log^10 CFU/g
Interval -2.2 to 5.8
|
SECONDARY outcome
Timeframe: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 daysPopulation: The reporting of this outcome measure is based on the confirmed biofilm analysis set, defined as all subjects admitted to the study and for which the presence of biofilm was confirmed using curettage samples (Initial Visit: N=14; Week 1: N=14; Week 2: N=13; Week 3: N=12; Week 4: N=12; Study Completion: N=14).
Calculated overall median/range measurements of the reference ulcer area (cm\^2) at each study visit as well as overall study completion ulcer area measurements were assessed for the Iodosorb and Solosite arms. The ulcer area was calculated as area = length x width x 0.785.
Outcome measures
| Measure |
Solosite Gel
n=7 Participants
Hydrogel with preservatives, used to create a moist wound environment.
Solosite gel: Hydrogel
|
Iodosorb
n=7 Participants
Cadexomer iodine gel
Iodosorb: Cadexomer iodine gel
|
|---|---|---|
|
Ulcer Area Measurements at Each Study Visit
Week 3 Ulcer Area Measurement
|
8.0 cm^2
Interval 2.9 to 12.0
|
7.0 cm^2
Interval 0.8 to 10.4
|
|
Ulcer Area Measurements at Each Study Visit
Baseline Ulcer Area Measurement
|
9.4 cm^2
Interval 5.1 to 21.2
|
8.5 cm^2
Interval 2.1 to 13.0
|
|
Ulcer Area Measurements at Each Study Visit
Week 1 Ulcer Area Measurement
|
9.4 cm^2
Interval 3.9 to 19.4
|
7.3 cm^2
Interval 1.2 to 12.1
|
|
Ulcer Area Measurements at Each Study Visit
Week 2 Ulcer Area Measurement
|
8.1 cm^2
Interval 4.0 to 14.1
|
7.8 cm^2
Interval 0.9 to 11.2
|
|
Ulcer Area Measurements at Each Study Visit
Week 4 Ulcer Area Measurement
|
6.1 cm^2
Interval 4.4 to 9.7
|
6.8 cm^2
Interval 0.8 to 11.5
|
|
Ulcer Area Measurements at Each Study Visit
Study Completion Ulcer Area Measurement
|
5.5 cm^2
Interval 4.4 to 9.7
|
7.8 cm^2
Interval 0.8 to 11.5
|
SECONDARY outcome
Timeframe: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 daysOverall percentage (%) of change in ulcer area from Baseline to final visit for the Iodosorb and Solosite arms.
Outcome measures
| Measure |
Solosite Gel
n=7 Participants
Hydrogel with preservatives, used to create a moist wound environment.
Solosite gel: Hydrogel
|
Iodosorb
n=7 Participants
Cadexomer iodine gel
Iodosorb: Cadexomer iodine gel
|
|---|---|---|
|
Percentage (%) Change in Ulcer Area
|
29.4 percent change
Standard Deviation 23.1
|
24.8 percent change
Standard Deviation 39.0
|
SECONDARY outcome
Timeframe: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 daysPopulation: The reporting of this outcome measure is based on the confirmed biofilm analysis set, defined as all subjects admitted to the study and for which the presence of biofilm was confirmed using curettage samples (Initial Visit: N=14; Week 1: N=14; Week 2: N=13; Week 3: N=12; Week 4: N=12; Study Completion: N=14).
Calculated median/range measurements of the reference ulcer depth (mm) at each study visit as well as overall study completion ulcer depth measurements were assessed for the Iodosorb and Solosite arms. The ulcer depth as measured by inserting the cotton applicator into the deepest part of the ulcer and measuring from the tip of the applicator to the level of the skin surface.
Outcome measures
| Measure |
Solosite Gel
n=7 Participants
Hydrogel with preservatives, used to create a moist wound environment.
Solosite gel: Hydrogel
|
Iodosorb
n=7 Participants
Cadexomer iodine gel
Iodosorb: Cadexomer iodine gel
|
|---|---|---|
|
Ulcer Depth Measurements at Each Study Visit
Baseline Ulcer Depth Measurement
|
4 mm
Interval 0.7 to 20.0
|
2 mm
Interval 0.2 to 6.0
|
|
Ulcer Depth Measurements at Each Study Visit
Week 1 Ulcer Depth Measurement
|
3 mm
Interval 0.2 to 30.0
|
2 mm
Interval 1.0 to 4.0
|
|
Ulcer Depth Measurements at Each Study Visit
Week 2 Ulcer Depth Measurement
|
2.5 mm
Interval 2.0 to 28.0
|
2 mm
Interval 1.0 to 3.0
|
|
Ulcer Depth Measurements at Each Study Visit
Week 3 Ulcer Depth Measurement
|
2 mm
Interval 1.0 to 30.0
|
1.5 mm
Interval 1.0 to 3.0
|
|
Ulcer Depth Measurements at Each Study Visit
Week 4 Ulcer Depth Measurement
|
2.5 mm
Interval 1.0 to 5.0
|
1.5 mm
Interval 1.0 to 3.0
|
|
Ulcer Depth Measurements at Each Study Visit
Study Completion Ulcer Depth Measurement
|
3 mm
Interval 1.0 to 5.0
|
2 mm
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 daysOverall percentage (%) of change in ulcer depth from Baseline to final visit for the Iodosorb and Solosite arms.
Outcome measures
| Measure |
Solosite Gel
n=7 Participants
Hydrogel with preservatives, used to create a moist wound environment.
Solosite gel: Hydrogel
|
Iodosorb
n=7 Participants
Cadexomer iodine gel
Iodosorb: Cadexomer iodine gel
|
|---|---|---|
|
Percentage (%) Change in Ulcer Depth
|
-7.9 percent change
Standard Deviation 143.8
|
-38.1 percent change
Standard Deviation 165.2
|
SECONDARY outcome
Timeframe: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 daysPopulation: The reporting of this outcome measure is based on the confirmed biofilm analysis set, defined as all subjects admitted to the study and for which the presence of biofilm was confirmed using curettage samples (Initial Visit: N=14; Week 1: N=14; Week 2: N=13; Week 3: N=12; Week 4: N=12; Study Completion: N=14).
Calculated median/range measurements of the ulcer volume (cm\^3) at each study visit as well as overall study completion ulcer volume measurements were assessed for the Iodosorb and Solosite arms. The ulcer volume was measured by calculating the length x width x depth of the ulcer.
Outcome measures
| Measure |
Solosite Gel
n=7 Participants
Hydrogel with preservatives, used to create a moist wound environment.
Solosite gel: Hydrogel
|
Iodosorb
n=7 Participants
Cadexomer iodine gel
Iodosorb: Cadexomer iodine gel
|
|---|---|---|
|
Ulcer Volume Measurements at Each Study Visit
Baseline Ulcer Volume Measurement
|
3.8 cm^3
Interval 0.8 to 15.8
|
1.7 cm^3
Interval 0.0 to 6.4
|
|
Ulcer Volume Measurements at Each Study Visit
Week 1 Ulcer Volume Measurement
|
3.3 cm^3
Interval 0.2 to 34.3
|
0.9 cm^3
Interval 0.1 to 3.6
|
|
Ulcer Volume Measurements at Each Study Visit
Week 2 Ulcer Volume Measurement
|
2.6 cm^3
Interval 0.8 to 19.4
|
1.3 cm^3
Interval 0.2 to 3.4
|
|
Ulcer Volume Measurements at Each Study Visit
Week 3 Ulcer Volume Measurement
|
1.7 cm^3
Interval 0.6 to 22.8
|
1.1 cm^3
Interval 0.1 to 3.0
|
|
Ulcer Volume Measurements at Each Study Visit
Week 4 Ulcer Volume Measurement
|
1.8 cm^3
Interval 0.5 to 2.9
|
1.1 cm^3
Interval 0.1 to 2.4
|
|
Ulcer Volume Measurements at Each Study Visit
Study Completion Ulcer Volume Measurement
|
1.6 cm^3
Interval 0.5 to 2.9
|
1.1 cm^3
Interval 0.1 to 2.4
|
SECONDARY outcome
Timeframe: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 daysOverall percentage (%) of change in ulcer volume from Baseline to final visit for the Iodosorb and Solosite arms.
Outcome measures
| Measure |
Solosite Gel
n=7 Participants
Hydrogel with preservatives, used to create a moist wound environment.
Solosite gel: Hydrogel
|
Iodosorb
n=7 Participants
Cadexomer iodine gel
Iodosorb: Cadexomer iodine gel
|
|---|---|---|
|
Percentage (%) Change in Ulcer Volume
|
15.0 percent change
Standard Deviation 119.1
|
21.5 percent change
Standard Deviation 57.5
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4Population: The reporting of this outcome measure is based on the confirmed biofilm analysis set, defined as all subjects admitted to the study and for which the presence of biofilm was confirmed using curettage samples (Initial Visit: N=14; Week 1: N=14; Week 2: N=13; Week 3: N=12; Week 4: N=12; Study Completion: N=14).
Assessment of subjects clinically judged to have biofilm present on the wound. The presumption of biofilm was determined on visual appearance to the Investigator and compared to microbial swab laboratory test confirmation. Biofilm is a microbial colony encased in a polysaccharide matrix which can become attached to a wound surface and prevent healing. Biofilm can appear as a shiny or slimy layer (clear to yellowish in appearance) on a wound bed.
Outcome measures
| Measure |
Solosite Gel
n=7 Participants
Hydrogel with preservatives, used to create a moist wound environment.
Solosite gel: Hydrogel
|
Iodosorb
n=7 Participants
Cadexomer iodine gel
Iodosorb: Cadexomer iodine gel
|
|---|---|---|
|
Presence of Biofilm by Clinical Judgment Versus Presence of Biofilm by Laboratory Test
Biofilm Present by Laboratory Test at Baseline · Yes
|
7 Participants
|
7 Participants
|
|
Presence of Biofilm by Clinical Judgment Versus Presence of Biofilm by Laboratory Test
Biofilm Present by Laboratory Test at Baseline · No
|
0 Participants
|
0 Participants
|
|
Presence of Biofilm by Clinical Judgment Versus Presence of Biofilm by Laboratory Test
Biofilm Present by Clinical Judgment at Baseline · Yes
|
7 Participants
|
7 Participants
|
|
Presence of Biofilm by Clinical Judgment Versus Presence of Biofilm by Laboratory Test
Biofilm Present by Clinical Judgment at Baseline · No
|
0 Participants
|
0 Participants
|
|
Presence of Biofilm by Clinical Judgment Versus Presence of Biofilm by Laboratory Test
Biofilm Present by Laboratory Test at Week 2 · Yes
|
6 Participants
|
6 Participants
|
|
Presence of Biofilm by Clinical Judgment Versus Presence of Biofilm by Laboratory Test
Biofilm Present by Laboratory Test at Week 2 · No
|
0 Participants
|
1 Participants
|
|
Presence of Biofilm by Clinical Judgment Versus Presence of Biofilm by Laboratory Test
Biofilm Present by Clinical Judgment at Week 2 · Yes
|
6 Participants
|
5 Participants
|
|
Presence of Biofilm by Clinical Judgment Versus Presence of Biofilm by Laboratory Test
Biofilm Present by Clinical Judgment at Week 2 · No
|
0 Participants
|
2 Participants
|
|
Presence of Biofilm by Clinical Judgment Versus Presence of Biofilm by Laboratory Test
Biofilm Present by Laboratory Test at Week 4 · Yes
|
5 Participants
|
4 Participants
|
|
Presence of Biofilm by Clinical Judgment Versus Presence of Biofilm by Laboratory Test
Biofilm Present by Laboratory Test at Week 4 · No
|
1 Participants
|
2 Participants
|
|
Presence of Biofilm by Clinical Judgment Versus Presence of Biofilm by Laboratory Test
Biofilm Present by Clinical Judgment at Week 4 · Yes
|
5 Participants
|
4 Participants
|
|
Presence of Biofilm by Clinical Judgment Versus Presence of Biofilm by Laboratory Test
Biofilm Present by Clinical Judgment at Week 4 · No
|
1 Participants
|
2 Participants
|
Adverse Events
Solosite Gel
Iodosorb
Serious adverse events
| Measure |
Solosite Gel
n=9 participants at risk
Hydrogel with preservatives, used to create a moist wound environment.
Solosite gel: Hydrogel
|
Iodosorb
n=10 participants at risk
Cadexomer iodine gel
Iodosorb: Cadexomer iodine gel
|
|---|---|---|
|
General disorders
Right Foot Abscess with Osteomyelitis
|
0.00%
0/9 • Adverse event data were collected from the time of randomization up through 28 days (+/- 4 days).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from the time of randomization up through 28 days (+/- 4 days).
|
|
General disorders
Spinal Infection
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of randomization up through 28 days (+/- 4 days).
|
0.00%
0/10 • Adverse event data were collected from the time of randomization up through 28 days (+/- 4 days).
|
Other adverse events
| Measure |
Solosite Gel
n=9 participants at risk
Hydrogel with preservatives, used to create a moist wound environment.
Solosite gel: Hydrogel
|
Iodosorb
n=10 participants at risk
Cadexomer iodine gel
Iodosorb: Cadexomer iodine gel
|
|---|---|---|
|
General disorders
Foot Laceration
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected from the time of randomization up through 28 days (+/- 4 days).
|
0.00%
0/10 • Adverse event data were collected from the time of randomization up through 28 days (+/- 4 days).
|
|
General disorders
Open Ulcer, Left Great Toe
|
0.00%
0/9 • Adverse event data were collected from the time of randomization up through 28 days (+/- 4 days).
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected from the time of randomization up through 28 days (+/- 4 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place