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

Inclusion Criteria:

1. The patient is able to understand the study and is willing to consent to the study.

2. The patient consents to the ongoing use of their de-identified photos by the Sponsor
for purposes outside of this study.

3. The patient must be at least 18 years of age.

4. Males and females - provided they are not pregnant or lactating and if of
reproductive age are using contraception.

5. The patient has presented with a DFU which, according to the clinical judgement of
the Investigator, has a suspected biofilm

6. 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

7. The patient's ulcer is suitable to be dressed with IODOSORB or SOLOSITE.

8. The patient has an ABPI >0.49; or toe pressure >50mmHg.

Exclusion Criteria:

1. Patients with a known history of poor compliance with medical treatment.

2. Patients who have participated in this study previously and who healed or were
withdrawn.

3. Patients who are participating in any other clinical study.

4. 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.

5. Patients with a history of any thyroid disorders, e.g. Hashimoto's thyroiditis,
Graves disease or non-toxic nodular goitre.

6. Patients undergoing treatment with mercurial antiseptics, taurolidine or lithium.

7. Patients with a known sensitivity to iodine or any of the other ingredients in
IODOSORB, SOLOSITE or ALLEVYN Non-adhesive

8. Patients with severe renal impairment

9. Patients with an ulcer less than 3cm diameter.

10. Patients with an ulcer that is not exuding.