NCT02228122

Brief Summary

The purpose of the research is to assess the effects of Aquacel Ag+ Extra dressing on chronic wound bacterial biofilms

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

7 months

First QC Date

August 26, 2014

Last Update Submit

December 1, 2015

Conditions

DiabetesChronic Foot Wounds

Keywords

Chronic woundsBiofilmsBacteria

Outcome Measures

Primary Outcomes (1)

  • A measure of the presence/absence of biofilms in over five weeks when exposed to Aquacel Ag+ Extra dressing.

    Wound debridement tissue derived from standard of care will be retained for analysis up to Day 28. Tissue to be sectioned and analysed for the presence or absence of bacterial biofilms.

    up to day 28

Secondary Outcomes (1)

  • Size of the wound and an indicator of healing

    up to day 28

Study Arms (1)

Aquacel® Ag+ Extra

EXPERIMENTAL
Device: Aquacel® Ag+ Extra

Interventions

Aquacel® Ag+ ExtraDEVICE

Aquacel® Ag+ Extra dressing will be applied to wounds as per instructions for use, dressing to be changed at least one per week for 4 weeks.

Aquacel® Ag+ Extra

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provided written informed consent
  • Be over 18 years of age
  • Must have a chronic foot wound greater than 4 weeks in duration
  • Be willing and able to attend the clinic for the required study visits -

You may not qualify if:

  • Subjects with a history of sensitivity to any one of the components of the device being studied
  • Subjects who are currently participating in or have been on a clinical study within the last 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manchester Diabetes Centre

Manchester, M13 0JE, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Andrew J McBain, BSc, PhD

    University of Manchester

    PRINCIPAL INVESTIGATOR

  • Angela Oates, BSc, MSc, PhD, FIBMS

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 26, 2014

First Posted

August 28, 2014

Study Start

October 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-12

Locations

GB(1)