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

Primary Purpose

Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer

Status
Terminated
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Leia
Sponsored by
Molnlycke Health Care AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Ulcer

Eligibility Criteria

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

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

Sites / Locations

  • Sahlgrenska clinical trial center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Device, dressing

Dressing , device

Arm Description

Intervention: Device, Leia dressing

Intervention: Device: Hydroactive surgical dressing

Outcomes

Primary Outcome Measures

Absorption of Wound Exudates.
Absorption capacity measured subjectively: NA/POOR/GOOD/VERY GOOD/EXCELLENT

Secondary Outcome Measures

Full Information

First Posted
October 9, 2013
Last Updated
December 22, 2015
Sponsor
Molnlycke Health Care AB
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1. Study Identification

Unique Protocol Identification Number
NCT01966380
Brief Title
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device, dressing
Arm Type
Experimental
Arm Description
Intervention: Device, Leia dressing
Arm Title
Dressing , device
Arm Type
Active Comparator
Arm Description
Intervention: Device: Hydroactive surgical dressing
Intervention Type
Device
Intervention Name(s)
Leia
Other Intervention Name(s)
Leia consist of conducting and absorbing part., Device: Hydroactive surgical dressing, It is a synergetic combination of a hydroactive surgical dressing
Primary Outcome Measure Information:
Title
Absorption of Wound Exudates.
Description
Absorption capacity measured subjectively: NA/POOR/GOOD/VERY GOOD/EXCELLENT
Time Frame
2-3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sahlgrenska clinical trial center
City
Göteborg
ZIP/Postal Code
41346
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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