A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing

Molnlycke Health Care

Status: Enrolling

Conditions: Venous Leg Ulcer; Wound of Skin; Wounds; Wound Leg

Treatments: Device: ALLEVYN Non-Adhesive

Study type: Interventional

Funder types: Industry

Identifiers

NCT05608317

DIPLO NBF

Details and patient eligibility

About

The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit.

Participants will be asked to wear the dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.

Full description

This investigation is designed as a prospective, open, multi-center, interventional, non-comparative investigation with the aim to follow chronic wound progression for 6 weeks according to local standard of care. Wound progress is a summary endpoint of the total effect of treatment using the non-bordered foam dressing as the absorbent dressing and includes the changes in an objectively measured wound area and subjectively evaluated wound condition. The only included indication is Venous Leg Ulcers (VLU). A total of n=20 participants will be recruited at up to 6 centers within the US and Canada.

There will be a total of seven (7) visits to the investigation site for participants during the treatment period: baseline, followed by weekly visits up to six (6) weeks post baseline. During visits, evaluations will be performed to assess wound progression and status, wound dressing properties, as well as Subject pain, comfort, and quality of life. Safety will be assessed at all visits. One target wound per participant will be included in this investigation.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed consent to participate (including consent for digital imaging)
• Adult aged ≥18 years
• Diagnosed with a chronic, exuding VLU
• Exudate amount moderate to large
• Wound size from 3 cm2 to 30 cm2, as determined by the clinician
• ABPI (within 3 months) > 0.7. If ABPI > 1.4, then big toe pressure > 60 mmHg is required or an alternative measurement verifying normal distal arterial flow
• Willing to be compliant with compression therapy

Exclusion criteria

• Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at enrollment
• Circumferential wound
• Known allergy/hypersensitivity to the materials of the dressing
• Use of wound fillers

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Supportive Care with Non-Bordered Foam Dressing

Experimental group

Description:

All Subjects will use a non-bordered foam dressing as the absorbent primary dressing.

Treatment:

Device: ALLEVYN Non-Adhesive