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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

NCT ID: NCT01966380

Last Updated: 2015-12-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Leg Ulcer Diabetic Foot Ulcer Pressure Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Device, dressing

Intervention: Device, Leia dressing

Group Type EXPERIMENTAL

Leia

Intervention Type DEVICE

Dressing , device

Intervention: Device: Hydroactive surgical dressing

Group Type ACTIVE_COMPARATOR

Leia

Intervention Type DEVICE

Interventions

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Leia

Intervention Type DEVICE

Other Intervention Names

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Leia consist of conducting and absorbing part. Device: Hydroactive surgical dressing It is a synergetic combination of a hydroactive surgical dressing

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Molnlycke Health Care AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sahlgrenska clinical trial center

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Leia

Identifier Type: -

Identifier Source: org_study_id