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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Cadexomer iodine gel
Hydrogel
St Lukes Roosevelt Hospital
New York, New York, United States
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.
Time frame: Baseline to Week 4
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days
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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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 2, Week 4