Status:
RECRUITING
A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
Lead Sponsor:
Molnlycke Health Care AB
Conditions:
Wounds
Wound of Skin
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
This investigation is designed as a prospective, open, multi-center, interventional, non-comparative investigation with the aim to follow exuding chronic wound progression for 6 weeks according to loc...
Eligibility Criteria
Inclusion Criteria:
- Signed consent to participate (including consent for digital imaging)
- Adult aged ≥18 years
- Diagnosed with a chronic, exuding VLU or DFU
- Exudate amount moderate to large
- Wound size from 3 cm2 to 30 cm2 for VLU and ≥1 cm2 for DFU, as determined by the clinician
- For VLU: 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
- For VLU: 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
- Patients participating in the DIPLO NBF study
- Use of wound fillers
Key Trial Info
Start Date :
October 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT05588583
Start Date
October 31 2022
End Date
March 1 2024
Last Update
April 20 2023
Active Locations (4)
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1
Center for Clinical Research, Inc.
Castro Valley, California, United States, 94546
2
Felix Sigal, DPM
Los Angeles, California, United States, 90010
3
University of Miami
Miami, Florida, United States, 33125
4
Serena Group Research Institute
Pittsburgh, Pennsylvania, United States, 15222