Actively Recruiting
A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
Led by Molnlycke Health Care AB · Updated on 2023-04-20
68
Participants Needed
4
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. 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 Mepilex Up 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 Wounds Using Mepilex® Up as the Primary Dressing.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed consent to participate, including consent for digital imaging
- Adults aged 18 years or older
- Diagnosed with a chronic, exuding venous leg ulcer or diabetic foot ulcer
- Wound exudate amount is moderate to large
- Wound size from 3 cm2 to 30 cm2 for venous leg ulcers, or at least 1 cm2 for diabetic foot ulcers
- For venous leg ulcers: Ankle Brachial Pressure Index (ABPI) within 3 months greater than 0.7
- For venous leg ulcers: If ABPI is greater than 1.4, big toe pressure greater than 60 mmHg or alternative normal distal arterial flow measurement is required
- For venous leg ulcers: 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 dressing materials
- Participation in the DIPLO NBF study
- Use of wound fillers
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Center for Clinical Research, Inc.
Castro Valley, California, United States, 94546
Actively Recruiting
2
Felix Sigal, DPM
Los Angeles, California, United States, 90010
Actively Recruiting
3
University of Miami
Miami, Florida, United States, 33125
Actively Recruiting
4
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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