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

Venous Leg Ulcer Clinical Trial

— DEVO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909870
• Other study ID #: ABH-Dermagraft-001-08
• Status: Completed
• Phase: Phase 3
• Start date: June 2009
• Est. completion date: August 2011

Study information

• Verified date: May 2018
• Source: Organogenesis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 537
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >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

• 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.

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

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

Locations

Country	Name	City	State
Austria	Private Practice FA fur Dermatologie Clinical Centre	Hartberg
Austria	Private Practice / Clinical Centre	Vienna
Estonia	East-Tallinn Central Hospital	Tallinn
Germany	Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt	Freiburg
Germany	Germeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter	Hamburg
Poland	Institution DER-ART Scientific Research and Training Centre for Dermatosurgery	Gdynia
Poland	5 Wojskowy Szpital Kliniczny w Krakowie	Krakow
Poland	AKMed Medical Centre	Krakow
Poland	Malopolskie Centrum Medyczne	Krakow
Poland	NZOZ Clinical for Vascular Diseases	Krakow
Poland	S. Zeromski Hospital Krakow	Krakow
Poland	NZOZ "Dermed" Medical Centre (Centrum Medyczne Sp. z.o.o.)	Lodz
Poland	Clinical Trials Centre	Lublin
Poland	"NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology	Nowy Sacz
Poland	"Medyk" Medical Center	Rzeszow
Poland	General Surgery Clinic Autonomous Public Central Clinical Hospital (SPCSK)	Warszawa
Poland	NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wroclawskie Centrum Zdrowia)	Wroclaw
South Africa	Worthwhile Clinical Trials Lakeview Hospital	Benoni	Johannesburg
South Africa	Josha Research	Bloemfontein
South Africa	Edenvale Hospital, c/o CEO Secretary	Edenvale	Johhanesburg
South Africa	Dr. D.R.Lakha, Private Practice	Johannesburg
South Africa	GCT-Mercantile Clinical Trial Centre	Korsten	Port Elizabeth
South Africa	Langeberg Medical Centre	Kraaifontein	Cape Town
South Africa	I Engelbrecht Research	Lyttelton
South Africa	Synexus SA Watermeyer Clinical Research Centre	Meyerspark	Pretoria
South Africa	Middelburg Hospital	Middelburg
South Africa	Uncedo Clinical Research Services Mercantile Hospital	Port Elizabeth
South Africa	Cachetmed Medical Centre	Potchefstroom
South Africa	Randles Road Medical Centre	Sydenham, Durban
South Africa	Clinical Projects Research SA	Worcester
Sweden	University of Lund Dept of Dermatology	Lund
Sweden	Overlakare/Klinikchef Hud Kliniken	Stockholm
United Kingdom	Bradford Hospitals NHS Trust	Bradford
United Kingdom	Cardiff University	Cardiff
United Kingdom	Wound Clinic on Fairfield	Croydon	Surrey
United Kingdom	Charing Cross Hospital	London
United States	Foot & Ankle Associates of Florida	Altamonte Springs	Florida
United States	Bay Pines VA Healthcare System	Bay Pines	Florida
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston Medical Center, Department of Vascular Surgery	Boston	Massachusetts
United States	University of North Carolina Division of Vascular Surgery	Chapel Hill	North Carolina
United States	Comprehensive Wound Healing Center	Clearwater	Florida
United States	Broadlawns Medical Center	Des Moines	Iowa
United States	Saint Vincent Health Center	Erie	Pennsylvania
United States	Aiyan Diabetes Center	Evans	Georgia
United States	Dr. Jagpreet S. Mukker	Fresno	California
United States	Jackson Madison County General Hospital	Jackson	Tennessee
United States	Osceola Regional Wound Care Center	Kissimmee	Florida
United States	Advanced Foot & Ankle Center	Las Vegas	Nevada
United States	VA Northern California Health Care System	Mather	California
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	North American 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	Sutter Roseville Medical Center Wound Care Center	Roseville	California
United States	Covenant Wound Healing Center	Saginaw	Michigan
United States	Dixie Regional Meidcal Center	Saint George	Utah
United States	Heartland Regional Medical Center	Saint Joseph	Missouri
United States	Therapeutics Clinical Research	San Diego	California
United States	General Vascular Surgery Group	San Leandro	California
United States	Doctor's Research Network	South Miami	Florida
United States	Pacific Wound Center	Stockton	California
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Overlook Hospital Wound Healing Program	Summit	New Jersey
United States	Robert Snyder, DPM, CWS	Tamarac	Florida
United States	Southern Arizona VA Health Care System (SAVAHCS)	Tucson	Arizona
United States	University of Arizona College of Medicine	Tucson	Arizona
United States	Omega Medical Research	Warwick	Rhode Island
United States	Providence Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Organogenesis

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complete Healing by Week 16: Ulcers <= 12 Months Duration		16 weeks
Primary	Complete Healing of the Study Ulcer by Week 16.		16 weeks
Secondary	Time-to-Complete Healing	Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group.	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.