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NCT01966380 Clinical Trial

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

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01966380
Other study ID # Leia
Secondary ID
Status Terminated
Phase Phase 2
First received October 9, 2013
Last updated December 22, 2015
Start date September 2013
Est. completion date March 2014

Study information
Verified date December 2015
Source Molnlycke Health Care AB
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 6
Est. completion date March 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Leia

Locations
Country Name City State
Sweden Sahlgrenska clinical trial center Göteborg

Sponsors (1)
Lead Sponsor Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Absorption of Wound Exudates. Absorption capacity measured subjectively: NA/POOR/GOOD/VERY GOOD/EXCELLENT 2-3 weeks No
See also
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