Actively Recruiting
A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing
Led by Molnlycke Health Care AB · Updated on 2024-05-06
20
Participants Needed
3
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed consent to participate (including consent for digital imaging)
- Adult aged 60;18 years
- Diagnosed with a chronic, exuding venous leg ulcer
- Exudate amount moderate to large
- Wound size from 3 cm2 to 30 cm2, as determined by the clinician
- ABPI (within 3 months) �3E 0.7. If ABPI �3E 1.4, then big toe pressure �3E 60 mmHg is required or an alternative measurement verifying normal distal arterial flow
- Willing to be compliant with compression therapy
You will not qualify if you...
- Infected ulcer requiring systemic antibiotic therapy at enrollment
- Circumferential wound
- Known allergy or hypersensitivity to the dressing materials
- Use of wound fillers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Center for Clinical Trials, Inc.
San Francisco, California, United States, 94115
Not Yet Recruiting
2
University of Miami
Miami, Florida, United States, 33125
Actively Recruiting
3
Serena Group Research Institute
Pittsburgh, Pennsylvania, United States, 15222
Actively Recruiting
Research Team
J
Janet Kandrevas, MD, MS
CONTACT
A
Andrea Picchietti, MS, CCRA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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