Venous Leg UlcerPhase 3DEVONCT00909870

Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers

A Phase 3 study testing Dermagraft(R) and Profore in people with Venous Leg Ulcer, run by Organogenesis at 70 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Venous Leg Ulcer
What is being tested?: Dermagraft(R) and Profore
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 537 participants
Where: 70 sitesin 8 countries
Study dates: Jun 2009to Aug 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

>18 years of age
ABI > 0.80
Three or fewer venous leg ulcers, if multiple must be separated by 2 cm
Ultrasound demonstrates venous reflux >0.5 seconds
Study wound present for 1-24 months
Study wound 2-15 sq cm surface area

Show all 9Show fewer

Clean, granulating wound
Patient able and willing to sign informed consent and comply with study procedures.
Women of childbearing potential must use birth control pills, barriers or abstinence and have a negative pregnancy test.

Who cannot join

Wound etiology uncertain or not from venous hypertension.
BMI>40
Acute or chronic infectious skin disease
Allergy or intolerance to Profore(R)
Wound infection, cellulitis, osteomyelitis
>2 weeks' treatment with immunosuppressive agents in recent past

Show all 19Show fewer

Investigational drug use within 30 days
Severe malnutrition, drug and/or alcohol abuse
Malignant disease unless in remission for 5 years
History of radiation at the study site
Other conditions that could impede wound healing
Known history of HIV or AIDS
Prior participation in any Dermagraft study
Treatment with other bioengineered tissue products within 30 days
Unable to understand the aims and objectives of the trial
Inability to comply with study protocol
NYHA Class III or IV CHF
Uncontrolled diabetes mellitus
Dorsal foot ulcer

Trial locations and contacts

70 sites in 8 countries.

Country

City, postcode or hospital

70 sites in 8 countries

United States34 sites

Foot & Ankle Associates of Florida
Altamonte Springs, Florida, 32701
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744
Boston Medical Center, Department of Vascular Surgery
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of North Carolina Division of Vascular Surgery
Chapel Hill, North Carolina, 27599
Comprehensive Wound Healing Center
Clearwater, Florida, 33756
Broadlawns Medical Center
Des Moines, Iowa, 50314-1597
Saint Vincent Health Center
Erie, Pennsylvania, 16544
Aiyan Diabetes Center
Evans, Georgia, 30809
Dr. Jagpreet S. Mukker
Fresno, California, 93726
Jackson Madison County General Hospital
Jackson, Tennessee, 38301
Osceola Regional Wound Care Center
Kissimmee, Florida, 34741
Advanced Foot & Ankle Center
Las Vegas, Nevada, 89119
VA Northern California Health Care System
Mather, California, 95665
University of Miami Miller School of Medicine
Miami, Florida, 33136
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
North American Center for Limb Preservation
New Haven, Connecticut, 06515
Carl T. Hayden VA Medical Center
Phoenix, Arizona, 85012
HOPE Research Institute
Phoenix, Arizona, 85050
Sutter Roseville Medical Center Wound Care Center
Roseville, California, 95661
Covenant Wound Healing Center
Saginaw, Michigan, 48602
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
Therapeutics Clinical Research
San Diego, California, 92123
General Vascular Surgery Group
San Leandro, California, 94578
Doctor's Research Network
South Miami, Florida, 33143
Dixie Regional Meidcal Center
St. George, Utah, 84770
Pacific Wound Center
Stockton, California, 95204
Stony Brook University Medical Center
Stony Brook, New York, 11794
Overlook Hospital Wound Healing Program
Summit, New Jersey, 07901
Robert Snyder, DPM, CWS
Tamarac, Florida, 33321
Southern Arizona VA Health Care System (SAVAHCS)
Tucson, Arizona, 85723
University of Arizona College of Medicine
Tucson, Arizona, 85724
Omega Medical Research
Warwick, Rhode Island, 02886
Providence Hospital
Washington D.C., District of Columbia, 20017

Other trials in United States

South Africa13 sites

Worthwhile Clinical Trials Lakeview Hospital
Benoni, Johannesburg, 1500
Josha Research
Bloemfontein, 9301
Edenvale Hospital, c/o CEO Secretary
Edenvale, Johhanesburg, 1610
Dr. D.R.Lakha, Private Practice
Johannesburg, 1835
GCT-Mercantile Clinical Trial Centre
Korsten, Port Elizabeth, 6014
Langeberg Medical Centre
Kraaifontein, Cape Town, 7570
I Engelbrecht Research
Lyttelton, 0157
Synexus SA Watermeyer Clinical Research Centre
Meyerspark, Pretoria
Middelburg Hospital
Middelburg, 1055
Uncedo Clinical Research Services Mercantile Hospital
Port Elizabeth, 6014
Cachetmed Medical Centre
Potchefstroom, 2531
Randles Road Medical Centre
Sydenham, Durban, 4091
Clinical Projects Research SA
Worcester, 6850

Other trials in South Africa

Poland12 sites

Institution DER-ART Scientific Research and Training Centre for Dermatosurgery
Gdynia, 81-415
AKMed Medical Centre
Krakow, 30-312
NZOZ Clinical for Vascular Diseases
Krakow, 30-321
Malopolskie Centrum Medyczne
Krakow, 30-510
5 Wojskowy Szpital Kliniczny w Krakowie
Krakow, 30-901
S. Zeromski Hospital Krakow
Krakow, 31-913
NZOZ "Dermed" Medical Centre (Centrum Medyczne Sp. z.o.o.)
Lodz, 90-265
Clinical Trials Centre
Lublin, 20-022
"NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology
Nowy Sącz, 33-300
"Medyk" Medical Center
Rzeszów, 35-055
General Surgery Clinic Autonomous Public Central Clinical Hospital (SPCSK)
Warsaw, 02-097
NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wroclawskie Centrum Zdrowia)
Wroclaw, 54-610

Other trials in Poland

United Kingdom4 sites

Bradford Hospitals NHS Trust
Bradford, BD9 6RJ
Cardiff University
Cardiff, CF14 4XN
Wound Clinic on Fairfield
Croydon, Surrey, CR7 7YE
Charing Cross Hospital
London, W6 8RF

Other trials in United Kingdom

Austria2 sites

Private Practice FA fur Dermatologie Clinical Centre
Hartberg, 8230
Private Practice / Clinical Centre
Vienna, 1220

Other trials in Austria

Germany2 sites

Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt
Freiburg im Breisgau, D-79100
Germeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter
Hamburg, D-22177

Other trials in Germany

Sweden2 sites

University of Lund Dept of Dermatology
Lund
Overlakare/Klinikchef Hud Kliniken
Stockholm, SE-118 83

Other trials in Sweden

Estonia1 site

East-Tallinn Central Hospital
Tallinn, 11312

Other trials in Estonia

About this study

Official title: A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial

This study randomly assigns patients with venous leg ulcers to receive standard therapy (compression) alone or compression plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 16-week treatment period is complete. Follow-up visits are conducted monthly for three months in order to assess patients for longer term safety.

Conditions: Venous Leg Ulcer
Being tested: Dermagraft(R), Profore
Keywords: Venous leg ulcer, randomized trial, clinical trial, Dermagraft, compression therapy, surgical debridement, venous stasis, chronic ulcer, chronic wound, fibroblasts
Medical subject headings: Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dermagraft(R)Device
Weekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement.
ProforeDevice
Weekly application of Profore compression dressings, in combination with systematic surgical wound debridement.

Study groups in NCT00909870
Study group	Role	What they receive
1	Experimental	Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement. Receives: Device: Dermagraft(R)
2	Active comparator	Weekly application of compression dressings only, in combination with systematic surgical wound debridement. Receives: Device: Profore

What is being measured

The primary outcome is the main question the study is designed to answer.

Complete Healing of the Study Ulcer by Week 16.
Measured: 16 weeks

Secondary outcomes (1)

Time-to-Complete Healing
Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group.
Measured: From Week 0 visit to date subject's completely healed ulcer is 1st recorded as healed. If subject's ulcer not healed at 16 weeks, the "time until CH" was censored at 112 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Aug 2011

First posted29 May 2009 (estimated)
Study startJun 2009
Primary completionMay 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 537 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00909870
Sponsor's protocol ID: ABH-Dermagraft-001-08
Acronym: DEVO
Status last verified: May 2018
First submitted: 28 May 2009
Last updated: 18 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial
ClinicalTrials.gov ID: NCT00909870
Acronym / sponsor ID: DEVO / ABH-Dermagraft-001-08
Conditions: Venous Leg Ulcer
Keywords: Venous leg ulcer, randomized trial, clinical trial, Dermagraft, compression therapy, surgical debridement, venous stasis, chronic ulcer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 537 participants (actual)
Lead sponsor: OrganogenesisIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: May 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 29 May 2009 (estimated)
Results: Posted 4 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Device: Dermagraft(R)Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
2	Active comparator	Device: ProforeWeekly application of compression dressings only, in combination with systematic surgical wound debridement.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

>18 years of age
ABI > 0.80
Three or fewer venous leg ulcers, if multiple must be separated by 2 cm
Ultrasound demonstrates venous reflux >0.5 seconds
Study wound present for 1-24 months

Key exclusion criteria (19 listed)

Wound etiology uncertain or not from venous hypertension.
BMI>40
Acute or chronic infectious skin disease
Allergy or intolerance to Profore(R)
Wound infection, cellulitis, osteomyelitis

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
Dermagraft(R)Weekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement.	Device	1
ProforeWeekly application of Profore compression dressings, in combination with systematic surgical wound debridement.	Device	2

Primary outcome

Complete Healing of the Study Ulcer by Week 16.
Time frame: 16 weeks

1 secondary outcome

Time-to-Complete Healing
Time frame: From Week 0 visit to date subject's completely healed ulcer is 1st recorded as healed. If subject's ulcer not healed at 16 weeks, the "time until CH" was censored at 112 days.

Results and safety

Results posted to the registry on 4 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Investigational Treatment (Dermagraft Plus Standard-of-Care)	274	251
Active Control (Standard-of-Care)	263	236

Primary outcome: Complete Healing of the Study Ulcer by Week 16.

Time frame: 16 weeks. Number. Unit: participants

Measure	Investigational Treatment (Dermagraft Plus Standard-of-Care) n = 274	Control (Standard-of-Care) n = 263
Value	201	176

Investigational Treatment (Dermagraft Plus Standard-of-Care) vs Control (Standard-of-Care): Difference in proportions: 6.5, p = 0.1030, Chi-squared

Population analysed: Intent-to-Treat population

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational Treatment (Dermagraft Plus Standard-of-Care)	28 of 274 (10.2%)	168 of 274 (61.3%)	Not reported
Control (Standard-of-Care)	24 of 263 (9.1%)	157 of 263 (59.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Venous Leg Ulcer

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
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Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
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Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
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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.

William Marston, MD principal investigator

University of North Carolina School of Medicine, Chapel Hill, NC

Keith Harding, MD principal investigator

Cardiff University School of Medicine, Wales, UK

David Bergqvist, MD principal investigator

University of Uppsala, Sweden

70 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dermagraft(R) and Profore in people with Venous Leg Ulcer, run by Organogenesis at 70 sites in 8 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 9 inclusion and 19 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 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, South Africa, Poland, United Kingdom, Austria and 3 more countries. 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?

Yes. Results are posted in the registry (first posted 4 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Complete Healing of the Study Ulcer by Week 16. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00909870.

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 18 Jun 2018.