A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
Recruiting now · Not applicable
Conditions studied: Wounds, Wound of Skin, Wound Leg, Wound; Foot, Diabetic Foot Ulcer, Venous Leg Ulcer
In brief
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.
Key facts
- Study ID
- NCT05588583
- Run by
- Molnlycke Health Care AB
- People needed
- 68
- Starts
- 2022-10-31
- Expected to finish
- 2024-03-01
- Last updated by the study team
- 2023-04-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify 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
- Patients participating in the DIPLO NBF study
- Use of wound fillers
Where it is running
- Center for Clinical Research, Inc. — Castro Valley, California, United States (enrolling)
- Felix Sigal, DPM — Los Angeles, California, United States (enrolling)
- University of Miami — Miami, Florida, United States (enrolling)
- Serena Group Research Institute — Pittsburgh, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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