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

Not Applicable

Terminated

Conditions: Diabetic Foot Ulcer

Interventions: Device: Solosite gel
Device: Iodosorb

Registration Number: NCT02181621

Lead Sponsor: Smith & Nephew, Inc.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 19

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Solosite gel	Solosite gel	Hydrogel with preservatives, used to create a moist wound environment.
Iodosorb	Iodosorb	Cadexomer iodine gel

Primary Outcome Measures

Name	Time	Method
Within-patient Change From Baseline in Log^10 Biofilm-protected Bacteria Count (Colony Forming Units [Cfu]/Gram[g])	Baseline to Week 4	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.

Secondary Outcome Measures

Name	Time	Method
Ulcer Volume Measurements at Each Study Visit	Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days	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.
Ulcer Area Measurements at Each Study Visit	Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days	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.
Ulcer Depth Measurements at Each Study Visit	Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days	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.
Percentage (%) Change in Ulcer Depth	Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days	Overall percentage (%) of change in ulcer depth from Baseline to final visit for the Iodosorb and Solosite arms.
Percentage (%) Change in Ulcer Volume	Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days	Overall percentage (%) of change in ulcer volume from Baseline to final visit for the Iodosorb and Solosite arms.
Presence of Biofilm by Clinical Judgment Versus Presence of Biofilm by Laboratory Test	Baseline, Week 2, Week 4	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.
Percentage (%) Change in Ulcer Area	Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days	Overall percentage (%) of change in ulcer area from Baseline to final visit for the Iodosorb and Solosite arms.