Chronic wound repair and healing in older adults: current status and future research.
Lisa Gould, Peter Abadir, Harold Brem...
https://pubmed.ncbi.nlm.nih.gov/25486905Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05588583
A Prospective, Open, Multi-Center, Interventional Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex Up
Led by Molnlycke Health Care AB · Updated on 2023-04-20
68
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the progress of chronic wounds, specifically venous leg ulcers (VLU) and diabetic foot ulcers (DFU), using an absorbent dressing called Mepilex Up. This study is a prospective, open, multi-center, interventional trial designed to observe wound healing over a period of up to six weeks. The goal is to track changes in wound area and condition while participants receive treatment according to local standards of care. Participants will use the Mepilex Up dressing, which is a soft, silicone-based absorbent foam dressing designed to manage wound exudate and protect the skin. The dressing will be applied as the primary dressing and changed weekly for up to six weeks or until the wound heals. The study includes seven visits: a baseline visit followed by weekly visits to monitor wound healing and dressing performance. During each visit, researchers will assess wound progress through measurements and evaluations of wound area, volume, tissue quality, exudate, and skin condition. Participants will report on pain, comfort, and quality of life related to wound care. Safety will be monitored at all visits. The total treatment period is a maximum of 44 days or until healing occurs, with detailed tracking of dressing wear time, wound changes, and any adverse events.
CONDITIONS
Brief Title
A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed consent to participate, including consent for digital imaging
- Adult aged �3e= 18 years
- Diagnosed with a chronic, exuding venous leg ulcer or diabetic foot ulcer
- Moderate to large amount of wound drainage (exudate)
- Wound size from 3 cm2 to 30 cm2 for venous leg ulcers and �3e= 1 cm2 for diabetic foot ulcers
- For venous leg ulcers: ABPI within 3 months > 0.7, or if ABPI > 1.4, big toe pressure > 60 mmHg or alternative test confirming normal blood flow
- For venous leg ulcers: Willing to comply with compression therapy
You will not qualify if you...
- Infected ulcer requiring systemic antibiotic therapy at enrollment
- Circumferential wound
- Known allergy or hypersensitivity to dressing materials
- Participation in the DIPLO NBF study
- Use of wound fillers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 weeks or until healed
Participants use Mepilex Up as the primary dressing for their chronic exuding wounds and attend weekly visits to assess wound progression, dressing properties, pain, comfort, quality of life, and safety.
7 visits (1 baseline and 6 weekly follow-up visits, in-person)
Trial Site Locations
Total: 4 locations
1
Center for Clinical Research, Inc.
Castro Valley, California, United States, 94546
Actively Recruiting
2
Felix Sigal, DPM
Los Angeles, California, United States, 90010
Actively Recruiting
3
University of Miami
Miami, Florida, United States, 33125
Actively Recruiting
4
Serena Group Research Institute
Pittsburgh, Pennsylvania, United States, 15222
Actively Recruiting
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Research Team
J
Janet Kandrevas, MD, MS
A
Andrea Picchietti, MS, CCRA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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Published Research Related To This Trial
Wound exudate: a survey of current understanding and clinical competency.
Joy Tickle
https://pubmed.ncbi.nlm.nih.gov/27119542Correlation between health-related quality of life and venous leg ulcer's severity and characteristics: a cross-sectional study.
Héctor González de la Torre, María L Quintana-Lorenzo, Estrella Perdomo-Pérez...
https://pubmed.ncbi.nlm.nih.gov/27112627Impact of exudate and odour from chronic venous leg ulceration.
J E Jones, Jude Robinson, Wally Barr...
https://pubmed.ncbi.nlm.nih.gov/18686695A study to compare a new self-adherent soft silicone dressing with a self-adherent polymer dressing in stage II pressure ulcers.
Sylive Maume, Dirk Van De Looverbosch, Hilde Heyman...
https://pubmed.ncbi.nlm.nih.gov/14581709Managing the problem of excess exudate.
Zena Moore, Helen Strapp
https://pubmed.ncbi.nlm.nih.gov/26266558Taking the trauma out of wound care: the importance of undisturbed healing.
M Rippon, P Davies, R White
https://pubmed.ncbi.nlm.nih.gov/22885308The influence of wound geometry on the measurement of wound healing rates in clinical trials.
D R Gorin, P R Cordts, W W LaMorte...
https://pubmed.ncbi.nlm.nih.gov/8601898Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review.
Marianne Jensen Hjermstad, Peter M Fayers, Dagny F Haugen...
https://pubmed.ncbi.nlm.nih.gov/21621130Validity and feasibility of the wound-QoL questionnaire on health-related quality of life in chronic wounds.
Matthias Augustin, Elena Conde Montero, Nicole Zander...
https://pubmed.ncbi.nlm.nih.gov/29080332