Diabetic Foot UlcerNCT02181621
A RCT to Compare the Effects of Two Wound Products on Biofilm Disruption in DFUs
A study testing Iodosorb and Solosite gel in people with Diabetic Foot Ulcer, run by Smith & Nephew, Inc. at 1 site in United States.
Trial summary
This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the wound bed diabetic foot ulcers. ◊ Trademark of Smith \& Nephew Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Iodosorb and Solosite gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is able to understand the study and is willing to consent to the study.
- The patient consents to the ongoing use of their de-identified photos by the Sponsor for purposes outside of this study.
- The patient must be at least 18 years of age.
- Males and females - provided they are not pregnant or lactating and if of reproductive age are using contraception.
- The patient has presented with a DFU which, according to the clinical judgement of the Investigator, has a suspected biofilm
- The patient has a DFU of Grade 1 or 2 according to the Meggit-Wagner scale. Grade 1 - Superficial ulcers limited to the dermis Grade 2 - Ulcers are transdermal with exposed bone or tendon, and without osteomyelitis or abscess formation
- The patient's ulcer is suitable to be dressed with IODOSORB or SOLOSITE.
- The patient has an ABPI >0.49; or toe pressure >50mmHg.
Who cannot join
- Patients with a known history of poor compliance with medical treatment.
- Patients who have participated in this study previously and who healed or were withdrawn.
- Patients who are participating in any other clinical study.
- Patients that have received continuous treatment with Iodosorb (on any wound) in the past 8 weeks (Iodosorb must not be continuously used for more 3 months) or whose reference ulcer has been treated with Iodosorb in the past 2 weeks.
- Patients with a history of any thyroid disorders, e.g. Hashimoto's thyroiditis, Graves disease or non-toxic nodular goitre.
- Patients undergoing treatment with mercurial antiseptics, taurolidine or lithium.
Show all 10Show fewer
- Patients with a known sensitivity to iodine or any of the other ingredients in IODOSORB, SOLOSITE or ALLEVYN Non-adhesive
- Patients with severe renal impairment
- Patients with an ulcer less than 3cm diameter.
- Patients with an ulcer that is not exuding.
Trial locations and contacts
1 site in 1 country.
United States1 site
St Lukes Roosevelt Hospital
New York, New York, 10019
About this study
Official title: A Prospective, Open, Comparative, Randomized, Single-centre Study to Evaluate the Effect of Cadexomer Iodine Gel (IODOSORB) Compared to Standard Dressings (SOLOSITE) on Biofilm Disruption in Infected Diabetic Foot Ulcers (DFUs)
This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the wound bed diabetic foot ulcers.
◊ Trademark of Smith \& Nephew
Read the detailed description
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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Iodosorb, Solosite gel
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IodosorbDevice
Cadexomer iodine gel
Solosite gelDevice
Hydrogel
| Study group | Role | What they receive |
|---|---|---|
| Solosite gel | Placebo comparator | Hydrogel with preservatives, used to create a moist wound environment. Receives: Device: Solosite gel |
| Iodosorb | Active comparator | Cadexomer iodine gel Receives: Device: Iodosorb |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 4
Secondary outcomes (7)
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.
Measured: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
Percentage (%) Change in Ulcer Area
Overall percentage (%) of change in ulcer area from Baseline to final visit for the Iodosorb and Solosite arms.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 2, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: Recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Lantis, BSc, MD, Principal investigator, St Lukes Roosevelt Hospital CenterMatthew Christensen, Study chair, Smith & Nephew, Inc. - SVP Global Clinical & Medical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181621
- Sponsor's protocol ID
- CE048IOD
- Status last verified
- Jul 2015
- First submitted
- 2 Jul 2014
- Last updated
- 29 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Comparative, Randomized, Single-centre Study to Evaluate the Effect of Cadexomer Iodine Gel (IODOSORB) Compared to Standard Dressings (SOLOSITE) on Biofilm Disruption in Infected Diabetic Foot Ulcers (DFUs)
- ClinicalTrials.gov ID
- NCT02181621
- Acronym / sponsor ID
- CE048IOD
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 4 Jul 2014 (estimated)
- Results
- Posted 29 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the wound bed diabetic foot ulcers.
◊ Trademark of Smith \& Nephew
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solosite gel | Placebo comparator | Device: Solosite gelHydrogel with preservatives, used to create a moist wound environment. |
| Iodosorb | Active comparator | Device: IodosorbCadexomer iodine gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient is able to understand the study and is willing to consent to the study.
- The patient consents to the ongoing use of their de-identified photos by the Sponsor for purposes outside of this study.
- The patient must be at least 18 years of age.
- Males and females - provided they are not pregnant or lactating and if of reproductive age are using contraception.
- The patient has presented with a DFU which, according to the clinical judgement of the Investigator, has a suspected biofilm
Key exclusion criteria (10 listed)
- Patients with a known history of poor compliance with medical treatment.
- Patients who have participated in this study previously and who healed or were withdrawn.
- Patients who are participating in any other clinical study.
- Patients that have received continuous treatment with Iodosorb (on any wound) in the past 8 weeks (Iodosorb must not be continuously used for more 3 months) or whose reference ulcer has been treated with Iodosorb in the past 2 weeks.
- Patients with a history of any thyroid disorders, e.g. Hashimoto's thyroiditis, Graves disease or non-toxic nodular goitre.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IodosorbCadexomer iodine gel | Device | Iodosorb |
| Solosite gelHydrogel | Device | Solosite gel |
Primary outcome
Within-patient Change From Baseline in Log^10 Biofilm-protected Bacteria Count (Colony Forming Units [Cfu]/Gram[g])
Time frame: Baseline to Week 4
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.
7 secondary outcomes
Ulcer Area Measurements at Each Study Visit
Time frame: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
Percentage (%) Change in Ulcer Area
Time frame: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
Ulcer Depth Measurements at Each Study Visit
Time frame: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
Percentage (%) Change in Ulcer Depth
Time frame: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
Ulcer Volume Measurements at Each Study Visit
Time frame: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
Percentage (%) Change in Ulcer Volume
Time frame: 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
Time frame: Baseline, Week 2, Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Lantis, BSc, MD principal investigator
St Lukes Roosevelt Hospital Center
Matthew Christensen study chair
Smith & Nephew, Inc. - SVP Global Clinical & Medical Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iodosorb and Solosite gel in people with Diabetic Foot Ulcer, run by Smith & Nephew, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-patient Change From Baseline in Log^10 Biofilm-protected Bacteria Count (Colony Forming Units [Cfu]/Gram[g]) (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.