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Tissue Matrix
Clinical Effectiveness of DermACELL AWM in Subjects With Chronic Venous Leg Ulcers
N/A
Waitlist Available
Research Sponsored by LifeNet Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
No Placebo-Only Group
Summary
This study is a multicenter, randomized, controlled, open-label trial designed to evaluate the safety and efficacy of DermACELL in subjects with a single target chronic venous leg ulcer (VLU).
Eligible Conditions
- Venous Leg Ulcer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Healing Rate
Secondary study objectives
Time to wound closure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DermACELL AWM + Conventional CareExperimental Treatment1 Intervention
DermACELL AWM, acellular dermal matrix, plus conventional wound care- DermACELL AWM will be applied at the Baseline visit. Conventional wound care will include advanced wound dressings and multilayer compression.
Group II: Conventional CareActive Control1 Intervention
Conventional wound care will include advanced wound dressings and multilayer compression.
Find a Location
Who is running the clinical trial?
LifeNet HealthLead Sponsor
14 Previous Clinical Trials
1,192 Total Patients Enrolled