Venous Leg UlcerPhase 3LTFUNCT01891760
Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
A Phase 3 study testing Dermagraft and Profore in people with Venous Leg Ulcer, run by Shire Regenerative Medicine, Inc. at 28 sites in 6 countries.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Dermagraft and Profore
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 28 sitesin 6 countries
- Study dates
- May 2010to Jun 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
United States12 sites
Saint Vincent Health Center
Erie, Pennsylvania, 16544
Dr. Jagpreet S. Mukker
Fresno, California, 93722
Advanced Foot & Ankle Center
Las Vegas, Nevada, 89119
VA Northern California Health Care Sytem
Mather, California, 95665
University of Miami Miller School of Medicine
Miami, Florida, 33125
North Amercian Center for Limb Preservation
New Haven, Connecticut, 06515
Carl T. Hayden VA Medical Center
Phoenix, Arizona, 85012
Hope Research Institute
Phoenix, Arizona, 85018
Covenant Wound Healing Center
Saginaw, Michigan, 48602
Doctor's Research Network
South Miami, Florida, 33143
Stony Brook University Medical Center
Stony Brook, New York, 11794
South Florida Wound Care Group, P.A.
Tamarac, Florida, 33321
Poland6 sites
AKMed Medical Center, Department of Vascular Surgery
Krakow, 30-312
Vascular Surgery, Tomasz Aleksiejew-Kleszczynski (Chirurgia Naczyn)
Krakow, 30-347
NZOZ "'Dermed" Medical Center (Centrum Medyczne Sp. z o.o.
Lodz, 90-265
"Medicos" Medical Center
Lublin, 20-844
"NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology
Nowy Sącz, 33-300
NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wrocławskie Centrum Zdrowia)
Wroclaw, 54-610
South Africa6 sites
Lakeview Hospital
Benoni, 1500
Josha Research
Bloemfontein, 9300
Randles Road Medical Centre
Durban, 4091
GCT-Mercantile Clinical Trial Centre
Port Elizabeth, 6014
Cachetnied Medical Centre
Potchefstroom, 2530
Boland Ethical Research Group
Worcester, 6850
Germany2 sites
Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt
Freiburg im Breisgau, D-79100
Gemeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter
Hamburg, D-22177
Estonia1 site
East-Tallinn Central Hospital Department of Rheumatology
Tallinn, 11312
United Kingdom1 site
Cardiff University Dept. of Wound Healing School of Medicine
Cardiff, CF 14 4XN
About this study
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
- 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)
- Conditions
- Venous Leg Ulcer
- Being tested
- Dermagraft, Profore
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermagraftDevice
Dermagraft treatment regimen of one application applied topically to the ulcer, weekly, for a maximum of 8 weeks (8 application maximum).
ProforeDevice
Four-layer compression bandaging therapy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Dermagraft - Allogenic Neonatal Dermal Fibroblasts Seeded on poly(glycolide-co-L-lactide)(PGLLA)Scaffold Receives: Device: Dermagraft |
| Reference Therapy | Active comparator | Profore - Four-layer compression bandaging therapy Receives: Device: Profore |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of study ulcer recurrence
Measured: 1 year
Secondary outcomes (5)
Incidence of complete study ulcer healing
Measured: 1 year
Incidence of study ulcer infection-related events
Measured: 1 year
Time to study ulcer recurrence
Measured: 1 year
Change in ulcer size
Measured: 1 year
Time to study ulcer healing
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startMay 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire Regenerative Medicine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mollie Carter, MD, Study director, Shire Regenerative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891760
- Sponsor's protocol ID
- ABH-Dermagraft-001-09
- Acronym
- LTFU
- Status last verified
- Aug 2013
- First submitted
- 28 Jun 2013
- Last updated
- 21 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01891760
- Acronym / sponsor ID
- LTFU / ABH-Dermagraft-001-09
- Conditions
- Venous Leg Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Shire Regenerative Medicine, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 3 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: DermagraftDermagraft - Allogenic Neonatal Dermal Fibroblasts Seeded on poly(glycolide-co-L-lactide)(PGLLA)Scaffold |
| Reference Therapy | Active comparator | Device: ProforeProfore - Four-layer compression bandaging therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DermagraftDermagraft treatment regimen of one application applied topically to the ulcer, weekly, for a maximum of 8 weeks (8 application maximum). | Device | Treatment |
| ProforeFour-layer compression bandaging therapy. | Device | Reference Therapy |
Primary outcome
The incidence of study ulcer recurrence
Time frame: 1 year
5 secondary outcomes
Incidence of complete study ulcer healing
Time frame: 1 year
Incidence of study ulcer infection-related events
Time frame: 1 year
Time to study ulcer recurrence
Time frame: 1 year
Change in ulcer size
Time frame: 1 year
Time to study ulcer healing
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
- ClinicalTrials.gov registry for the Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers (DEVO)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mollie Carter, MD study director
Shire Regenerative Medicine
28 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dermagraft and Profore in people with Venous Leg Ulcer, run by Shire Regenerative Medicine, Inc. at 28 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Poland, South Africa, Germany, Estonia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of study ulcer recurrence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2013.