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

Molnlycke Health Care

Status and phase: Terminated; Phase 2

Conditions: Pressure Ulcer; Diabetic Foot Ulcer; Leg Ulcer

Treatments: Device: Leia

Study type: Interventional

Funder types: Industry

Identifiers

NCT01966380

Leia

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Device, dressing

Experimental group

Description:

Intervention: Device, Leia dressing

Treatment:

Device: Leia

Dressing , device

Active Comparator group

Description:

Intervention: Device: Hydroactive surgical dressing

Treatment:

Device: Leia