Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia

December 22, 2015 updated by: Molnlycke Health Care AB

An Open Randomised, Prospective, Crossover, Proof of Concept (Design Validation) Clinical Investigation to Caompare the Performance and Safety of Wound Dressing(Leia) Compared to and Hydroactive Surgical Dressing on Low to Highly Exuding Wounds

The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic foot ulcer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Göteborg, Sweden, 41346
        • Sahlgrenska clinical trial center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Low to highly exuding chronic wound(wound history > 2 months) such as Leg Ulcer, Pressure Ulcer Category III to IV or Diabetic Foot Ulcer
  • Male of female, 18 years and above
  • Signed Informed Consent Form

Exclusion Criteria:

  • Pregnancy or lactation
  • Wound size not suitable for the wound dressing size
  • Known allergy/hypersensitivity to any of the components in the dressing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device, dressing
Intervention: Device, Leia dressing
Device: Leia
Other Names:
  • Leia consist of conducting and absorbing part.
  • Device: Hydroactive surgical dressing
  • It is a synergetic combination of a hydroactive surgical dressing
Active Comparator: Dressing , device
Intervention: Device: Hydroactive surgical dressing
Device: Leia
Other Names:
  • Leia consist of conducting and absorbing part.
  • Device: Hydroactive surgical dressing
  • It is a synergetic combination of a hydroactive surgical dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absorption of Wound Exudates.
Time Frame: 2-3 weeks
Absorption capacity measured subjectively: NA/POOR/GOOD/VERY GOOD/EXCELLENT
2-3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Molnlycke Health Care AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

October 16, 2013

First Posted (Estimate)

October 21, 2013

Study Record Updates

Last Update Posted (Estimate)

December 23, 2015

Last Update Submitted That Met QC Criteria

December 22, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Leia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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