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New treatment option for Wounds
Official title A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
ClinicalTrials.gov ID: NCT05588583
What this study is testing
- What it's testing
- 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.
- Time commitment: about 6 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely 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...
- Circumferential wound
- Known allergy/hypersensitivity to the materials of the dressing
- Patients participating in the DIPLO NBF study
- Use of wound fillers
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Castro Valley, California, United States
- Los Angeles, California, United States
- Miami, Florida, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Castro Valley, California, United States; Los Angeles, California, United States; Miami, Florida, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.