What this study is
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.
What's being tested
- ALLEVYN Non-Adhesive
Intervention · 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
- Official title
- A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Venous Leg Ulcers Using a Non-Bordered Foam Dressing
- Sponsor
- Molnlycke Health Care AB
- Conditions
- Wounds · Wound of Skin · Wound Leg · Venous Leg Ulcer
- Enrolling
- 20 people
- Starts
- 2022-11-08
- Est. completion
- 2024-11-30
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openCenter for Clinical Trials, Inc.
San Francisco, California, United States
- Gayana Sarkisova, CCRC · Contact800-363-1063 ext. 104gayana@ccr-trials.com
- Alexander Reyzelman, DPO · Principal investigator
Not yet recruitingUniversity of Miami
Miami, Florida, United States
- Aliette Espinosa · Contact305-689-3376a.espinosa2@med.miami.edu
- Hadar Lev-Tov, MD · Principal investigator
RecruitingSerena Group Research Institute
Pittsburgh, Pennsylvania, United States
- Laura Serena · Contact412-335-0764lserena@serenagroups.com
- Thomas Serena, MD · Principal investigator
Recruiting
Study team
Sponsor
Molnlycke Health Care AB
Study ID DIPLO NBF
Principal investigator
Hadar Lev-Tov, MD, MAS
University of Miami
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.