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NCT01891760 Clinical Trial

Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers

Venous Leg Ulcer Clinical Trial

— LTFU  

Official title:
A Prospective, Multi-center, Longitudinal, Cohort Study of Dermagraft in Subjects With Venous Leg Ulcers: A Long-term Follow-up to the DEVO-Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01891760
Other study ID # ABH-Dermagraft-001-09
Secondary ID
Status Completed
Phase Phase 3
First received June 28, 2013
Last updated August 9, 2013
Start date May 2010
Est. completion date June 2012

Study information
Verified date August 2013
Source Shire Regenerative Medicine, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 225
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Subject has completed study ABH-Dermagraft-001-08

2. Subject understands study requirements

3. Subject is available to participate in the 1 year-long observational follow-up.

Exclusion Criteria:

1. Subject who withdrew or was terminated from ABH-Dermagraft-001-08 before completion

2. Subject is not available for the 1 year-long observational period.

3. Subject has any condition(s) which seriously compromises the subject's ability to complete the study

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Dermagraft
Dermagraft treatment regimen of one application applied topically to the ulcer, weekly, for a maximum of 8 weeks (8 application maximum).
• Profore
Four-layer compression bandaging therapy.

Locations
Country Name City State
Estonia East-Tallinn Central Hospital Department of Rheumatology Tallin
Germany Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt Freiburg
Germany Gemeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter Hamburg
Poland AKMed Medical Center, Department of Vascular Surgery Krakow
Poland Vascular Surgery, Tomasz Aleksiejew-Kleszczynski (Chirurgia Naczyn) Krakow
Poland NZOZ "'Dermed" Medical Center (Centrum Medyczne Sp. z o.o. Lodz
Poland "Medicos" Medical Center Lublin
Poland "NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology Nowy Sacz
Poland NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wroclawskie Centrum Zdrowia) Wroclaw
South Africa Lakeview Hospital Benoni
South Africa Josha Research Bloemfontein
South Africa Randles Road Medical Centre Durban
South Africa GCT-Mercantile Clinical Trial Centre Port Elizabeth
South Africa Cachetnied Medical Centre Potchefstroom
South Africa Boland Ethical Research Group Worcester
United Kingdom Cardiff University Dept. of Wound Healing School of Medicine Cardiff
United States Saint Vincent Health Center Erie Pennsylvania
United States Dr. Jagpreet S. Mukker Fresno California
United States Advanced Foot & Ankle Center Las Vegas Nevada
United States VA Northern California Health Care Sytem Mather California
United States University of Miami Miller School of Medicine Miami Florida
United States North Amercian Center for Limb Preservation New Haven Connecticut
United States Carl T. Hayden VA Medical Center Phoenix Arizona
United States Hope Research Institute Phoenix Arizona
United States Covenant Wound Healing Center Saginaw Michigan
United States Doctor's Research Network South Miami Florida
United States Stony Brook University Medical Center Stony Brook New York
United States South Florida Wound Care Group, P.A. Tamarac Florida

Sponsors (1)
Lead Sponsor Collaborator
Shire Regenerative Medicine, Inc.

Countries where clinical trial is conducted

United States,  Estonia,  Germany,  Poland,  South Africa,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of study ulcer recurrence 1 year
Secondary Incidence of complete study ulcer healing 1 year
Secondary Incidence of study ulcer infection-related events 1 year
Secondary Time to study ulcer recurrence 1 year
Secondary Change in ulcer size 1 year
Secondary Time to study ulcer healing 1 year
See also
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Withdrawn NCT02912858 - Intermittent Pneumatic Compression of the Foot vs Geko Plus R-2 Neuromuscular Electrostimulation Device in Venous Leg Ulcer Patients N/A
Completed NCT02482038 - Geko Venous Leg Ulcer Study N/A
Completed NCT02652572 - Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Venous Leg Ulcers Phase 1
Unknown status NCT01658618 - Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer N/A
Completed NCT05646121 - Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
Completed NCT03077165 - Dose-response Relationship Study of S42909 on Leg Ulcer Healing Phase 2
Completed NCT04461132 - The Effect of Manual Lymphatic Drainage N/A
Completed NCT05974982 - Treatment Outcome of Autologous PRP Versus Conventional Therapy Among Patients With Chronic Venous Leg Ulcers Phase 1
Completed NCT04011371 - Cyanoacrylate Closure for Treatment of Venous Leg Ulcers N/A
Not yet recruiting NCT03543007 - Evaluating the Safety and Efficacy of GrafixPL™PRIME for the Treatment of Chronic Venous Leg Ulcers N/A
Completed NCT03286140 - Early Venous Reflux Ablation Ulcer Trial N/A
Recruiting NCT05588583 - A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing. N/A
Not yet recruiting NCT04613687 - Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM) N/A
Recruiting NCT05549609 - A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers Phase 1/Phase 2
Recruiting NCT05409976 - The GORE® VIAFORT Vascular Stent IVC Study N/A
Not yet recruiting NCT05089890 - Clinical Investigation of Sorbact® Dressings N/A
Not yet recruiting NCT03670329 - Management of Infection Risk in Non-comparative Trial (MINT) N/A

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