A RCT to Compare the Effects of Two Wound Products on Biofilm Disruption in DFUs (NCT02181621) | Clinical Trial Compass
TerminatedNot Applicable
A RCT to Compare the Effects of Two Wound Products on Biofilm Disruption in DFUs
Stopped: Recruitment challenges
United States19 participantsStarted 2014-08
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Within-patient Change From Baseline in Log^10 Biofilm-protected Bacteria Count (Colony Forming Units [Cfu]/Gram[g])
. The patient's ulcer is suitable to be dressed with IODOSORB or SOLOSITE.
. The patient has an ABPI \>0.49; or toe pressure \>50mmHg.
Exclusion criteria
. 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.
. Patients with a known sensitivity to iodine or any of the other ingredients in IODOSORB, SOLOSITE or ALLEVYN Non-adhesive