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Recruitment challenges
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This study is a prospective comparative study to determine if an Iodine Gel (Iodosorbâ—Š) is better than standard dressing (Solositeâ—Š gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the wound bed diabetic foot ulcers.
â—Š Trademark of Smith & Nephew
IODOSORB gel is a cadexomer iodine product indicated for use in wet ulcers and wounds. As the use of IODOSORB has an anti-microbial effect and removes exudate continuously from the wound, a reduction in pain, odour, oedema, exudate, pus and debris, and microbial load including biofilm can be achieved, hence providing an environment conducive to the normal healing process. While evidence exists to support the use of IODOSORB in diabetic foot ulcers (DFUs) for the reduction of planktonic bacteria, little evidence exits for the effect of any topical therapy on non-planktonic or biofilm bacteria in-vivo. The aim of this study is to explore the effects of IODOSORB on biofilm in the wound, wound healing, and associated factors, such as odour, pain, and reduction of slough.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solosite gel | Placebo Comparator | Hydrogel with preservatives, used to create a moist wound environment. |
|
| Iodosorb | Active Comparator | Cadexomer iodine gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodosorb | Device | Cadexomer iodine gel |
| |
| Solosite gel |
| Measure | Description | Time Frame |
|---|---|---|
| Within-patient Change From Baseline in Log^10 Biofilm-protected Bacteria Count (Colony Forming Units [Cfu]/Gram[g]) | 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. | Baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Ulcer Area Measurements at Each Study Visit | 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. | Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Lantis, BSc, MD | St Lukes Roosevelt Hospital Center | Principal Investigator |
| Matthew Christensen | Smith & Nephew, Inc. - SVP Global Clinical & Medical Affairs | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Lukes Roosevelt Hospital | New York | New York | 10019 | United States |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | SOLOSITE | Hydrogel with preservatives, used to create a moist wound environment. SOLOSITE Gel: Hydrogel |
| FG001 | IODOSORB | Cadexomer iodine gel IODOSORB: Cadexomer iodine gel |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The reporting of baseline measures is based on the confirmed biofilm analysis set, defined as all subjects enrolled in the study and available for analysis for which the presence of biofilm was confirmed using curettage samples.
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| ID | Title | Description |
|---|---|---|
| BG000 | SOLOSITE Gel | Hydrogel with preservatives, used to create a moist wound environment. SOLOSITE Gel: Hydrogel |
| BG001 | IODOSORB | Cadexomer iodine gel IODOSORB: Cadexomer iodine gel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Within-patient Change From Baseline in Log^10 Biofilm-protected Bacteria Count (Colony Forming Units [Cfu]/Gram[g]) | 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. | 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. | Posted | Median | 95% Confidence Interval | log^10 CFU/g | Baseline to Week 4 |
|
Adverse event data were collected from the time of randomization up through 28 days (+/- 4 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Solosite Gel | Hydrogel with preservatives, used to create a moist wound environment. Solosite gel: Hydrogel |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right Foot Abscess with Osteomyelitis | General disorders | Systematic Assessment | Right foot abscess with osteomyelitis; right proximal phalanx and metatarsal head resection with washout and primary closure; not related to study or investigational product; resulted in study withdrawal. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot Laceration | General disorders | Systematic Assessment | Patient visited emergency room due to having stepped on glass; not study or investigational product related. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Christensen | Smith & Nephew, Inc. | +1-303-249-5812 | Matthew.Christensen@smith-nephew.com |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| Device |
Hydrogel |
|
| Percentage (%) Change in Ulcer Area | Overall percentage (%) of change in ulcer area from Baseline to final visit for the Iodosorb and Solosite arms. | Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days |
| Ulcer Depth Measurements at Each Study Visit | 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. | Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days |
| Percentage (%) Change in Ulcer Depth | Overall percentage (%) of change in ulcer depth from Baseline to final visit for the Iodosorb and Solosite arms. | Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days |
| Ulcer Volume Measurements at Each Study Visit | 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. | Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days |
| Percentage (%) Change in Ulcer Volume | Overall percentage (%) of change in ulcer volume from Baseline to final visit for the Iodosorb and Solosite arms. | Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days |
| Presence of Biofilm by Clinical Judgment Versus Presence of Biofilm by Laboratory Test | 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. | Baseline, Week 2, Week 4 |
| Enrollment Hold |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height (centimeters [cm]) | Mean | Standard Deviation | cm |
|
| Weight (kilograms [kg]) | Mean | Standard Deviation | kg |
|
| Baseline Reference Ulcer: Area (centimeters squared [cm^2]) | Median | Full Range | cm^2 |
|
| Baseline Reference Ulcer: Depth (millimeters [mm]) | Median | Full Range | mm |
|
| Reference Ulcer: Volume (centimeters cubed [cm^3]) | Median | Full Range | cm^3 |
|
| OG001 |
| Iodosorb |
Cadexomer iodine gel Iodosorb: Cadexomer iodine gel |
|
|
| Secondary | Ulcer Area Measurements at Each Study Visit | 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. | 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). | Posted | Median | Full Range | cm^2 | Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days |
|
|
|
| Secondary | Percentage (%) Change in Ulcer Area | Overall percentage (%) of change in ulcer area from Baseline to final visit for the Iodosorb and Solosite arms. | Posted | Mean | Standard Deviation | percent change | Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days |
|
|
|
| Secondary | Ulcer Depth Measurements at Each Study Visit | 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. | 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). | Posted | Median | Full Range | mm | Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days |
|
|
|
| Secondary | Percentage (%) Change in Ulcer Depth | Overall percentage (%) of change in ulcer depth from Baseline to final visit for the Iodosorb and Solosite arms. | Posted | Mean | Standard Deviation | percent change | Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days |
|
|
|
| Secondary | Ulcer Volume Measurements at Each Study Visit | 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. | 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). | Posted | Median | Full Range | cm^3 | Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days |
|
|
|
| Secondary | Percentage (%) Change in Ulcer Volume | Overall percentage (%) of change in ulcer volume from Baseline to final visit for the Iodosorb and Solosite arms. | Posted | Mean | Standard Deviation | percent change | Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days |
|
|
|
| Secondary | Presence of Biofilm by Clinical Judgment Versus Presence of Biofilm by Laboratory Test | 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. | 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). | Posted | Count of Participants | Participants | Baseline, Week 2, Week 4 |
|
|
|
| 0 |
| 9 |
| 1 |
| 9 |
| 1 |
| 9 |
| EG001 | Iodosorb | Cadexomer iodine gel Iodosorb: Cadexomer iodine gel | 0 | 10 | 1 | 10 | 1 | 10 |
|
| Spinal Infection | General disorders | Systematic Assessment | Not related to study or investigational product; resulted in study withdrawal. |
|
|
| Open Ulcer, Left Great Toe | General disorders | Systematic Assessment | Open ulcer (non-target ulcer) on left great toe which was not present one week prior; not related to study or investigational product. |
|
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| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| Week 1 Ulcer Area Measurement |
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| Week 2 Ulcer Area Measurement |
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| Week 3 Ulcer Area Measurement |
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| Week 4 Ulcer Area Measurement |
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| Study Completion Ulcer Area Measurement |
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| Week 1 Ulcer Depth Measurement |
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| Week 2 Ulcer Depth Measurement |
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| Week 3 Ulcer Depth Measurement |
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| Week 4 Ulcer Depth Measurement |
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| Study Completion Ulcer Depth Measurement |
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| Week 1 Ulcer Volume Measurement |
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| Week 2 Ulcer Volume Measurement |
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| Week 3 Ulcer Volume Measurement |
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| Week 4 Ulcer Volume Measurement |
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| Study Completion Ulcer Volume Measurement |
|
|
| No |
|
| Biofilm Present by Clinical Judgment at Baseline |
|
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| Biofilm Present by Laboratory Test at Week 2 |
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| Biofilm Present by Clinical Judgment at Week 2 |
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| Biofilm Present by Laboratory Test at Week 4 |
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| Biofilm Present by Clinical Judgment at Week 4 |
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|