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

NCT02181621 | Terminated Results

• 1 other identifier: CE048IOD
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Ulcer Area Measurements at Each Study Visit

  Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days

• Percentage (%) Change in Ulcer Area

  Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days

• Ulcer Depth Measurements at Each Study Visit

  Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days

• Percentage (%) Change in Ulcer Depth

  Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days

• Ulcer Volume Measurements at Each Study Visit

  Baseline up through Week 4 +/- 4 days or End of Study Visit, up to 32 days

Study Arms (2)

Solosite gel

PLACEBO COMPARATOR

Hydrogel with preservatives, used to create a moist wound environment.

Device: Solosite gel

Iodosorb

ACTIVE COMPARATOR

Cadexomer iodine gel

Device: Iodosorb

Interventions

Iodosorb DEVICE

Cadexomer iodine gel

Iodosorb

Solosite gel DEVICE

Hydrogel

Solosite gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (1)

St Lukes Roosevelt Hospital

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Matthew Christensen
• Organization: Smith & Nephew, Inc.

Matthew.Christensen@smith-nephew.com

+1-303-249-5812

Study Officials

• John Lantis, BSc, MD

  St Lukes Roosevelt Hospital Center

  PRINCIPAL INVESTIGATOR

• Matthew Christensen

  Smith & Nephew, Inc. - SVP Global Clinical & Medical Affairs

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 4, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 29, 2024
• Results First Posted: February 29, 2024

Record last verified: 2015-07

Locations

US (1)