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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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01966380
First Posted: October 21, 2013
Last Update Posted: December 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Molnlycke Health Care AB
  Purpose
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.

Condition Intervention Phase
Leg Ulcer Diabetic Foot Ulcer Pressure Ulcer Device: Leia Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Molnlycke Health Care AB:

Primary Outcome Measures:
  • Absorption of Wound Exudates. [ Time Frame: 2-3 weeks ]
    Absorption capacity measured subjectively: NA/POOR/GOOD/VERY GOOD/EXCELLENT


Enrollment: 6
Study Start Date: September 2013
Study Completion Date: March 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966380


Locations
Sweden
Sahlgrenska clinical trial center
Göteborg, Sweden, 41346
Sponsors and Collaborators
Molnlycke Health Care AB
  More Information

Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01966380     History of Changes
Other Study ID Numbers: Leia
First Submitted: October 9, 2013
First Posted: October 21, 2013
Results First Submitted: January 14, 2015
Results First Posted: December 23, 2015
Last Update Posted: December 23, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Leg Ulcer
Pressure Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases