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

Part of paid clinical trials in San Francisco, California.

Sponsor
Molnlycke Health Care AB
Study ID
NCT05608317
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ALLEVYN Non-Adhesive — DEVICE
    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 Details

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.

Key Dates

Start date
Nov 8, 2022
Status verified
May 2024
Primary completion
Jul 30, 2024
Completion
Nov 30, 2024

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Supportive Care with Non-Bordered Foam Dressing
    All Subjects will use a non-bordered foam dressing as the absorbent primary dressing.

Primary Outcome Measure

Wound progress of the total effect of treatment using ALLEVYN Non-Adhesive [ Time Frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Center for Clinical Trials, Inc.San FranciscoCalifornia94115
Gayana Sarkisova, CCRC
[email protected]
800-363-1063
Alexander Reyzelman, DPO (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33125
Aliette Espinosa
[email protected]
305-689-3376
Hadar Lev-Tov, MD (PRINCIPAL_INVESTIGATOR)
Serena Group Research InstitutePittsburghPennsylvania15222
Laura Serena
[email protected]
412-335-0764
Thomas Serena, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Center for Clinical Trials, Inc.· San Francisco, CAUniversity of Miami· Miami, FLSerena Group Research Institute· Pittsburgh, PA

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