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NCT05588583 · ClinicalTrials.gov registry record · NA
A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
A NA study of Diabetic Foot Ulcer and Venous Leg Ulcer, sponsored by Molnlycke Health Care AB.
- Recruiting
- Registry status
- NA
- Development phase
- 68
- Enrollment target
- 4
- Study locations
NCT05588583: Recruiting NA study of Diabetic Foot Ulcer and Venous Leg Ulcer, sponsored by Molnlycke Health Care AB.
NCT05588583 is a NA study of Diabetic Foot Ulcer and Venous Leg Ulcer that is actively recruiting participants, run by Molnlycke Health Care AB. The registered enrollment target is 68 participants, below the 254-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (73% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05588583, a NA study of Diabetic Foot Ulcer and Venous Leg Ulcer, is actively recruiting participants, sponsored by Molnlycke Health Care AB.
- RECRUITING
- Registry status
- NA
- Development phase
- 68 participants
- Enrollment target
- 4
- Study locations
Study 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 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.
Primary Outcome
Wound progress is the total effect of treatment using Mepilex Up as the absorbent dressing and includes the changes in an objectively measured wound area and subjectively evaluated wound condition by the treating investigator/designee. Wound progress will be assessed as deteriorated, no change, improved, or healed at each visit. Wound area will be measured by an independent evaluator assisted by digital software at each visit and recorded as cm2 using the formula, A= π\*L\*W/4.
Conditions Studied
Interventions
- DEVICE Mepilex Up
Study Locations (4)
California
- Center for Clinical Research, Inc. - Castro Valley
- Felix Sigal, DPM - Los Angeles
Florida
- University of Miami - Miami
Pennsylvania
- Serena Group Research Institute - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2022-10-31 |
| Est. Completion | 2024-03 |
| Phase | NA |
What NCT05588583 shows while recruiting
NCT05588583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 254-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (73% lower).
The record links to 6 conditions, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 1 intervention - of which Mepilex Up is the first listed.
NCT05588583 reports a single indexed study location in California, Florida, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05588583 about?
NCT05588583 is a clinical study titled "A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.". 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. Partic...
What is the current status of trial NCT05588583?
This trial is currently recruiting. It is a NA study. The enrollment target is 68 participants. The study started on 2022-10-31. Estimated completion is 2024-03.
What conditions does trial NCT05588583 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer, Venous Leg Ulcer, Wound of Skin, Wounds, Wound; Foot.
What interventions are being tested in trial NCT05588583?
The interventions under investigation include: Mepilex Up (DEVICE).
Who is sponsoring clinical trial NCT05588583?
This trial is sponsored by Molnlycke Health Care AB, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05588583 being conducted?
This trial has 4 study locations across California, Florida, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05588583's enrollment target sits among peer trials
68 43rd of 67 higher than 25 of 67 other Diabetic Foot Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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