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

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)

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

Study Overview

• Status: Terminated
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: Solosite gel; Device: Iodosorb

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • St Lukes Roosevelt Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Within-patient Change From Baseline in Log^10 Biofilm-protected Bacteria Count (Colony Forming Units [Cfu]/Gram[g])	The primary variable was the within-patient change from Baseline in log^10 biofilm-protected bacteria count from Baseline (initial assessment) to Week 4, as measured by curettage.	Baseline to Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ulcer Area Measurements at Each Study Visit	Calculated overall median/range measurements of the reference ulcer area (cm^2) at each study visit as well as overall study completion ulcer area measurements were assessed for the Iodosorb and Solosite arms. The ulcer area was calculated as area = length x width x 0.785.	Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
Percentage (%) Change in Ulcer Area	Overall percentage (%) of change in ulcer area from Baseline to final visit for the Iodosorb and Solosite arms.	Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
Ulcer Depth Measurements at Each Study Visit	Calculated median/range measurements of the reference ulcer depth (mm) at each study visit as well as overall study completion ulcer depth measurements were assessed for the Iodosorb and Solosite arms. The ulcer depth as measured by inserting the cotton applicator into the deepest part of the ulcer and measuring from the tip of the applicator to the level of the skin surface.	Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
Percentage (%) Change in Ulcer Depth	Overall percentage (%) of change in ulcer depth from Baseline to final visit for the Iodosorb and Solosite arms.	Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
Ulcer Volume Measurements at Each Study Visit	Calculated median/range measurements of the ulcer volume (cm^3) at each study visit as well as overall study completion ulcer volume measurements were assessed for the Iodosorb and Solosite arms. The ulcer volume was measured by calculating the length x width x depth of the ulcer.	Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
Percentage (%) Change in Ulcer Volume	Overall percentage (%) of change in ulcer volume from Baseline to final visit for the Iodosorb and Solosite arms.	Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
Presence of Biofilm by Clinical Judgment Versus Presence of Biofilm by Laboratory Test	Assessment of subjects clinically judged to have biofilm present on the wound. The presumption of biofilm was determined on visual appearance to the Investigator and compared to microbial swab laboratory test confirmation. Biofilm is a microbial colony encased in a polysaccharide matrix which can become attached to a wound surface and prevent healing. Biofilm can appear as a shiny or slimy layer (clear to yellowish in appearance) on a wound bed.	Baseline, Week 2, Week 4

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Principal Investigator: John Lantis, BSc, MD, St Lukes Roosevelt Hospital Center; Study Chair: Matthew Christensen, Smith & Nephew, Inc. - SVP Global Clinical & Medical Affairs

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 3, 2014
• First Posted (Estimated): July 4, 2014

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Anti-Infective Agents, Local; Anti-Infective Agents; Cadexomer iodine
• Other Study ID Numbers: CE048IOD