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

Primary Purpose

Diabetic Foot Ulcer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Iodosorb
Solosite gel
Sponsored by
Smith & Nephew Medical Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Patients who have participated in this study previously and who healed or were withdrawn.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.

Sites / Locations

  • St Lukes Roosevelt Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Solosite gel

Iodosorb

Arm Description

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

Cadexomer iodine gel

Outcomes

Primary Outcome Measures

Difference in number (cfu/g) of biofilm protected bacteria

Secondary Outcome Measures

Full Information

First Posted
July 2, 2014
Last Updated
November 16, 2015
Sponsor
Smith & Nephew Medical Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02181621
Brief Title
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

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
Recruitment challenges
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew Medical Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Solosite gel
Arm Type
Placebo Comparator
Arm Description
Hydrogel with preservatives, used to create a moist wound environment.
Arm Title
Iodosorb
Arm Type
Active Comparator
Arm Description
Cadexomer iodine gel
Intervention Type
Device
Intervention Name(s)
Iodosorb
Intervention Description
Cadexomer iodine gel
Intervention Type
Device
Intervention Name(s)
Solosite gel
Intervention Description
Hydrogel
Primary Outcome Measure Information:
Title
Difference in number (cfu/g) of biofilm protected bacteria
Time Frame
weeks 0 to 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Lantis, BSc, Doctor of Medicine
Organizational Affiliation
St Lukes Roosevelt Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Lukes Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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