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 is currently recruiting participants.
Verified September 2013 by Molnlycke Health Care AB
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01966380
First received: October 9, 2013
Last updated: October 16, 2013
Last verified: September 2013
  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: Parallel Assignment
Masking: 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:
  • Number of participants with Adverse events as a Measure of safety and telerability [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]
    Evaluate the performance of the investigational device dressing, with the regards to leakage, maceration and pain at dressing changes. ( Time fram: 2-3 weeks) ( Designated as safety issue: No)


Secondary Outcome Measures:
  • Evaluate the performance of the investigational device dressing. [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]
    Evaluate the performance of the investigational device dressing, with the regards to leakage, maceration and pain at dressing changes.


Estimated Enrollment: 36
Study Start Date: September 2013
Estimated Study Completion Date: February 2014
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01966380

Locations
Sweden
Sahlgrenska clinical trial center Recruiting
Göteborg, Sweden, 41346
Contact: Dan Curiac, MD    +46313421000      
Sponsors and Collaborators
Molnlycke Health Care AB
  More Information

No publications provided

Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01966380     History of Changes
Other Study ID Numbers: Leia
Study First Received: October 9, 2013
Last Updated: October 16, 2013
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014