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NCT05608317 · ClinicalTrials.gov registry record · NA
A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing
A NA study of Venous Leg Ulcer and Wound of Skin, sponsored by Molnlycke Health Care AB.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 3
- Study locations
NCT05608317: Recruiting NA study of Venous Leg Ulcer and Wound of Skin, sponsored by Molnlycke Health Care AB.
NCT05608317 is a NA study of Venous Leg Ulcer and Wound of Skin that is actively recruiting participants, run by Molnlycke Health Care AB. The registered enrollment target is 20 participants, below the 244-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (92% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05608317, a NA study of Venous Leg Ulcer and Wound of Skin, is actively recruiting participants, sponsored by Molnlycke Health Care AB.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 3
- Study locations
Study Summary
The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing. 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 the 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 ALLEVYN Non-Adhesive 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 ALLEVYN Non-Adhesive
Study Locations (3)
California
- Center for Clinical Trials, Inc. - San Francisco
Florida
- University of Miami - Miami
Pennsylvania
- Serena Group Research Institute - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-11-08 |
| Est. Completion | 2024-11-30 |
| Phase | NA |
What NCT05608317 shows while recruiting
NCT05608317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 244-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (92% lower).
The record links to 4 conditions, with Venous Leg Ulcer appearing as the primary indexed condition, and to 1 intervention - of which ALLEVYN Non-Adhesive is the first listed.
NCT05608317 reports a single indexed study location in California, Florida, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05608317 about?
NCT05608317 is a clinical study titled "A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing". The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing. 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 th...
What is the current status of trial NCT05608317?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2022-11-08. Estimated completion is 2024-11-30.
What conditions does trial NCT05608317 study?
This clinical trial studies the following conditions: Venous Leg Ulcer, Wound of Skin, Wounds, Wound Leg.
What interventions are being tested in trial NCT05608317?
The interventions under investigation include: ALLEVYN Non-Adhesive (DEVICE).
Who is sponsoring clinical trial NCT05608317?
This trial is sponsored by Molnlycke Health Care AB, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05608317 being conducted?
This trial has 3 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 NCT05608317's enrollment target sits among peer trials
20 33rd of 35 higher than 2 of 35 other Venous Leg Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Venous Leg 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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