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 (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
Who can participate
Age range18 Years
SexALL
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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
✓. 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 Patients who have participated in this study previously and who healed or were withdrawn.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.
What they're measuring
1
Within-patient Change From Baseline in Log^10 Biofilm-protected Bacteria Count (Colony Forming Units [Cfu]/Gram[g])