NCT01891760CompletedPhase 3
A Prospective, Multi-center, Longitudinal, Cohort Study of Dermagraft in Subjects With Venous Leg Ulcers: A Long-term Follow-up to the DEVO-Trial
Shire Regenerative Medicine, Inc.56 sites in 6 countries225 target enrollmentStarted: May 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 225
- Locations
- 56
- Primary Endpoint
- The incidence of study ulcer recurrence
Study Overview
Brief Summary
- Observe the long-term (1-year) outcomes of Dermagraft, compared with conventional treatment of four-layer compression bandaging therapy alone, in subjects who completed the ABH-Dermagraft-001-08 study.
- Study Hypothesis: N/A (Long-term follow-up study)
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject has completed study ABH-Dermagraft-001-08
- •Subject understands study requirements
- •Subject is available to participate in the 1 year-long observational follow-up.
Exclusion Criteria
- •Subject who withdrew or was terminated from ABH-Dermagraft-001-08 before completion
- •Subject is not available for the 1 year-long observational period.
- •Subject has any condition(s) which seriously compromises the subject's ability to complete the study
Outcomes
Primary Outcomes
The incidence of study ulcer recurrence
Time Frame: 1 year
Secondary Outcomes
- Incidence of complete study ulcer healing(1 year)
- Incidence of study ulcer infection-related events(1 year)
- Time to study ulcer recurrence(1 year)
- Change in ulcer size(1 year)
- Time to study ulcer healing(1 year)
Investigators
Study Sites (56)
Loading locations...
Similar Trials
Completed
Not Applicable
The Dermisgraft Epithelialization and Late Scar HealingBurnsNCT05189743University Hospital, Linkoeping23
Not yet recruiting
Not Applicable
Autologous Adipose Stem Cell Assisted Skin GraftSkin GraftNCT04532593Shanghai Jiao Tong University School of Medicine75
Withdrawn
Not Applicable
Effectiveness of CelluTome Epidermal Harvesting System in Autologous Skin Grafting of Chronic Wound PatientsWounds and InjuriesNCT02492048LifeBridge Health
Not yet recruiting
Not Applicable
Double-layer Artificial Dermal Repair Material Combined With Growth Factors is Used for Exposed Tendon WoundsOpen Wound of Hip With Tendon InvolvementNCT05600166Wang xingang110
Completed
Not Applicable
Efficacy and long-term effects of a specific dermatological rehabilitation program for patients with chronic pruritusL29.9Pruritus, unspecifiedDRKS00032659Fachklinik Bad Bentheim100