Clinical trial NCT02181621: A RCT to Compare the Effects of Two Wound Products on Biofilm Disruption in DFUs
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-04
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Within-patient Change From Baseline in Log^10 Biofilm-protected Bacteria Count (Colony Forming Units [Cfu]/Gram[g])
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Ulcer Area Measurements at Each Study Visit
timeFrame: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
measure: Percentage (%) Change in Ulcer Area
timeFrame: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
measure: Ulcer Depth Measurements at Each Study Visit
timeFrame: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
measure: Percentage (%) Change in Ulcer Depth
timeFrame: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
measure: Ulcer Volume Measurements at Each Study Visit
timeFrame: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
measure: Percentage (%) Change in Ulcer Volume
timeFrame: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
measure: Presence of Biofilm by Clinical Judgment Versus Presence of Biofilm by Laboratory Test
timeFrame: Baseline, Week 2, Week 4
Other outcomes:
Locations:
city: New York
country: United States
facility: St Lukes Roosevelt Hospital
state: New York
Study officials:
affiliation: St Lukes Roosevelt Hospital Center
name: John Lantis, BSc, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Smith & Nephew, Inc. - SVP Global Clinical & Medical Affairs
name: Matthew Christensen
role: STUDY_CHAIR
References: