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Clinical Trials in the USA / NCT05608317
Recruiting Not applicable

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

NCT05608317 · tracked via the Priya Life Science USA tracker
Sponsor
Molnlycke Health Care AB
Phase
Not applicable
Started
2022-11-08
Last updated
2024-05-06

Condition(s) studied

WoundsWound of SkinWound LegVenous Leg Ulcer

Investigational drug(s) / intervention(s)

ALLEVYN Non-Adhesive

ALLEVYN Non-Adhesive: ALLEVYN Non-Adhesive combines patient comfort with the tri-layer fluid management system that enables moist wound healing. It utilizes a unique triple action technology that manages fluid to maintain optimal moist wound healing conditions. It is ideal for fragile and sensitive skin due to its non-adherent wound contact layer and soft and conformable construction. ALLEVYN Non-Adhesive consists of the following layers: * Breathable top film * Highly absorbent foam core * Non-adhesive wound contact layer

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Wound progress of the total effect of treatment using ALLEVYN Non-Adhesive — From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
    Wound progress is the total effect of treatment using ALLEVYN Non-Adhesive as the absorbent dressing and includes the changes in an objectively measured wound area and subjectively evaluated wound condition by the treating investigator/designee. Wound progress will be assessed as deteriorated, no change, improved, or healed at each visit. Wound area will be measured by an independent evaluator assisted by digital software at each visit and recorded as cm2 using the formula, A= π\*L\*W/4.

Trial sites (3)

FacilityCityRegionStatus
Center for Clinical Trials, Inc. San Francisco California Not Yet Recruiting
University of Miami Miami Florida Recruiting
Serena Group Research Institute Pittsburgh Pennsylvania Recruiting

More Molnlycke Health Care AB trials in the USA

A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing. Recruiting
Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns Active, not recruiting

Other trials for the same condition

Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC Active, not recruiting
A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing. Recruiting
MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers Recruiting
Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center Recruiting
Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05608317 on ClinicalTrials.gov ↗ ← All trials in the USA