A RCT to Compare the Effects of Two Wound Products on Biofilm Disruption in DFUs

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Iodosorb
* Device: Solosite gel


Participation Criteria
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Eligibility Criteria
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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 Patients who have participated in this study previously and who healed or were withdrawn.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. 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 Patients with severe renal impairment Patients with an ulcer less than 3cm diameter. Patients with an ulcer that is not exuding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Solosite gel<br>Hydrogel with preservatives, used to create a moist wound environment. | Device: Solosite gel<br>* Hydrogel<br>|
| Active Comparator: Iodosorb<br>Cadexomer iodine gel | Device: Iodosorb<br>* Cadexomer iodine gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in number (cfu/g) of biofilm protected bacteria |  | weeks 0 to 4 |