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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Dermagraft - Allogenic Neonatal Dermal Fibroblasts Seeded on poly(glycolide-co-L-lactide)(PGLLA)Scaffold |
|
| Reference Therapy | Active Comparator | Profore - Four-layer compression bandaging therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermagraft | Device | Dermagraft treatment regimen of one application applied topically to the ulcer, weekly, for a maximum of 8 weeks (8 application maximum). |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of study ulcer recurrence | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complete study ulcer healing | 1 year | |
| Incidence of study ulcer infection-related events | 1 year | |
| Time to study ulcer recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mollie Carter, MD | Shire Regenerative Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carl T. Hayden VA Medical Center | Phoenix | Arizona | 85012 | United States | ||
| Hope Research Institute |
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| Label | URL |
|---|---|
| ClinicalTrials.gov registry for the Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers (DEVO) | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 14, 2014 | |
| Reset | Apr 17, 2014 | |
| Release | May 16, 2018 |
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| Profore | Device | Four-layer compression bandaging therapy. |
|
| 1 year |
| Change in ulcer size | 1 year |
| Time to study ulcer healing | 1 year |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Dr. Jagpreet S. Mukker | Fresno | California | 93722 | United States |
| VA Northern California Health Care Sytem | Mather | California | 95665 | United States |
| North Amercian Center for Limb Preservation | New Haven | Connecticut | 06515 | United States |
| University of Miami Miller School of Medicine | Miami | Florida | 33125 | United States |
| Doctor's Research Network | South Miami | Florida | 33143 | United States |
| South Florida Wound Care Group, P.A. | Tamarac | Florida | 33321 | United States |
| Covenant Wound Healing Center | Saginaw | Michigan | 48602 | United States |
| Advanced Foot & Ankle Center | Las Vegas | Nevada | 89119 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| Saint Vincent Health Center | Erie | Pennsylvania | 16544 | United States |
| East-Tallinn Central Hospital Department of Rheumatology | Tallinn | 11312 | Estonia |
| Dermatologische Gemeinschaftspraxis Professor Dr. med W. Vanscheidt | Freiburg im Breisgau | D-79100 | Germany |
| Gemeinschaftspraxis Dres. Münter, Schiewe, Pohl Studienzentrum Dr. Münter | Hamburg | D-22177 | Germany |
| AKMed Medical Center, Department of Vascular Surgery | Krakow | 30-312 | Poland |
| Vascular Surgery, Tomasz Aleksiejew-Kleszczynski (Chirurgia Naczyn) | Krakow | 30-347 | Poland |
| NZOZ "'Dermed" Medical Center (Centrum Medyczne Sp. z o.o. | Lodz | 90-265 | Poland |
| "Medicos" Medical Center | Lublin | 20-844 | Poland |
| "NZOZ OPTI-MED Henryk Kaczmarek" Private Outpatient Clinic of Internal Medicine, Gastroenterology and Radiology | Nowy Sącz | 33-300 | Poland |
| NZOZ "Ars Medica" S.c. Wroclaw Health Centre (Wrocławskie Centrum Zdrowia) | Wroclaw | 54-610 | Poland |
| Lakeview Hospital | Benoni | 1500 | South Africa |
| Josha Research | Bloemfontein | 9300 | South Africa |
| Randles Road Medical Centre | Durban | 4091 | South Africa |
| GCT-Mercantile Clinical Trial Centre | Port Elizabeth | 6014 | South Africa |
| Cachetnied Medical Centre | Potchefstroom | 2530 | South Africa |
| Boland Ethical Research Group | Worcester | 6850 | South Africa |
| Cardiff University Dept. of Wound Healing School of Medicine | Cardiff | CF 14 4XN | United Kingdom |
| Reset | Jun 14, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 14, 2014 | Apr 17, 2014 | |||
| May 16, 2018 | Jun 14, 2018 |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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