NCT01966380

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 21, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

December 23, 2015

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

5 months

First QC Date

October 9, 2013

Results QC Date

January 14, 2015

Last Update Submit

December 22, 2015

Conditions

Leg UlcerDiabetic Foot UlcerPressure Ulcer

Outcome Measures

Primary Outcomes (1)

  • Absorption of Wound Exudates.

    Absorption capacity measured subjectively: NA/POOR/GOOD/VERY GOOD/EXCELLENT

    2-3 weeks

Study Arms (2)

Device, dressing

EXPERIMENTAL

Intervention: Device, Leia dressing

Device: Leia

Dressing , device

ACTIVE COMPARATOR

Intervention: Device: Hydroactive surgical dressing

Device: Leia

Interventions

LeiaDEVICE
Also known as: Leia consist of conducting and absorbing part., Device: Hydroactive surgical dressing, It is a synergetic combination of a hydroactive surgical dressing
Device, dressingDressing , device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska clinical trial center

Gothenburg, 41346, Sweden

Location

MeSH Terms

Conditions

Leg UlcerDiabetic FootPressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Results Point of Contact

Title
Prof. Jan Faergemann
Organization
Sahlgrenska university hospital
jan.faergemann@derm.gu.se
031-3421000

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2013

First Posted

October 21, 2013

Study Start

September 1, 2013

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

December 23, 2015

Results First Posted

December 23, 2015

Record last verified: 2015-12

Locations

SE(1)