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The main purpose of the study is to compare treatment of non-infected venous leg ulcers using ICXP007 combined with four-layer compression bandaging, placebo combined with four-layer compression bandaging and four-layer compression bandaging alone.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICXP007 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of 100% closure (epithelialized) at any time during the initial 12 weeks of the treatment period. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall rate of wound area reduction during treatment. | ||
| Time to first closure. | ||
| Incidence of closure at 16, 20 and 24 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Advanced Wound Care | Terminated | Montgomery | Alabama | 36111 | United States | |
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| Incidence of reopening at up to 16, 20 and 24 weeks. |
| Incidence of re-closure at 16, 20 and 24 weeks. |
| Qualitative levels of wound pain. |
| Percentage of Day 0 wound surface area. |
| Percentage reduction in wound surface area from previous visit. |
| Percentage reduction in wound surface area from Day 0. |
| Appearance of new ulcer in the target wound area post closure. |
| HOPE Research Institute |
| Recruiting |
| Phoenix |
| Arizona |
| 85050 |
| United States |
|
| Southern Arizona VA Health Care System | Recruiting | Tucson | Arizona | 85723 | United States |
|
| Alameda County Medical Center | Withdrawn | Alameda | California | 94602 | United States |
| Manzainto Medical Clinic | Recruiting | Carmichael | California | 95608 | United States |
|
| Bay Area Foot Care | Active, not recruiting | Castro Valley | California | 94546 | United States |
| M Limova, MD | Active, not recruiting | Fresno | California | 93711 | United States |
| VA Medical Center | Active, not recruiting | Sacramento | California | 95655 | United States |
| Bay Area Foot care | Active, not recruiting | San Francisco | California | 94115 | United States |
| University of Florida, Department of Surgery | Terminated | Gainesville | Florida | 32610 | United States |
| Dr Francisco Kerdel | Active, not recruiting | Miami | Florida | 33136 | United States |
| Doctor's Research Network | Recruiting | Miami | Florida | 33143 | United States |
|
| Dermatology and Cosmetic Specialists | Terminated | Miramar | Florida | 33027 | United States |
| Dr. Robert Snyder | Recruiting | Tamarac | Florida | 33321 | United States |
|
| National Centre for Limb Preservation | Recruiting | Niles | Illinois | 60714 | United States |
|
| Centre for Lower Ambulatory Research, Rosalind Franklin University of Medicine & Science | Recruiting | North Chicago | Illinois | 60064 | United States |
|
| Prairie Vascular Institute | Recruiting | Springfield | Illinois | 62702 | United States |
|
| The Wound Healing Center | Terminated | Terre Haute | Indiana | 47807 | United States |
| Boston Medical Center, Department of Vascular Surgery | Recruiting | Boston | Massachusetts | 02118 | United States |
|
| Dermatology, PLLC | Active, not recruiting | Ann Arbor | Michigan | 48103 | United States |
| Advanced Foot and Ankle Center | Recruiting | Las Vegas | Nevada | 89119 | United States |
|
| Montefiore Medical Center | Not yet recruiting | The Bronx | New York | 10467-2490 | United States |
|
| UNC Wound Care Clinic | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
|
| OSU Comprehensive Wound Center | Recruiting | Columbus | Ohio | 43205 | United States |
|
| OSU Comprehensive Wound Center | Recruiting | Columbus | Ohio | 43221 | United States |
|
| St Vincent Health Center | Recruiting | Erie | Pennsylvania | 16544 | United States |
|
| Armstrong County Memorial Hospital | Recruiting | Kittanning | Pennsylvania | 16201 | United States |
|
| Penn North Centers for Advanced Wound Care | Recruiting | Warren | Pennsylvania | 16365 | United States |
|
| Roger Williams Medical Centre | Recruiting | Providence | Rhode Island | 02908 | United States |
|
| Madigan Army Medical Center | Recruiting | Tacoma | Washington | 98431 | United States |
|
| Central Washington Podiatry | Active, not recruiting | Yakima | Washington | 98902 | United States |
| Western Canada Dermatology Institute | Terminated | Edmonton | Alberta | T5J 3S9 | Canada |
| Clinical Trials Unit, Skin Care Centre | Completed | Vancouver | British Columbia | V5Z 4E8 | Canada |
| Eastern Canada Cutaneous Research Associates Ltd | Terminated | Halifax | Nova Scotia | B3H 1Z4 | Canada |
| Parkwood Hospital, St Joseph's Health Care | Recruiting | London | Ontario | N6C 2J1 | Canada |
|
| Gary Sibbald, MD | Completed | Mississauga | Ontario | L4Y 1A6 | Canada |
| Entralogix | Recruiting | Oakville | Ontario | L6K 1E1 | Canada |
|
| Dermatology Daycare | Completed | Toronto | Ontario | M5S 1B2 | Canada |
| St Michael's Hospital | Recruiting | Toronto | Ontario | M5W 1WB | Canada |
|
| Entralogix | Recruiting | Welland | Ontario | L0S 1C0 | Canada |
|
| Centre Medical Ste-Dorothee | Completed | Laval | Quebec | H7X 3S5 | Canada |
| Department of Vascular Surgery, Manchester Royal Infirmary | Active, not recruiting | Manchester | Lancashire | M13 9WL | United Kingdom |
| Clatterbridge Hospital, Surgical Outpatients | Recruiting | Upton | Wirral | CH49 5PE | United Kingdom |
|
| Aberdeen Royal Infirmary | Recruiting | Aberdeen | AB25 2ZN | United Kingdom |
|
| Belfast City Hospital | Not yet recruiting | Belfast | BT9 1NR | United Kingdom |
|
| Birmingham Heartlands Hospital, University Department of Vascular Surgery | Recruiting | Birmingham | B9 5SS | United Kingdom |
|
| Bradford Royal Infirmary | Active, not recruiting | Bradford | BD9 6RJ | United Kingdom |
| Cardiff University | Recruiting | Cardiff | CF14 4XN | United Kingdom |
|
| St Richards Hospital | Not yet recruiting | Chichester | PO19 6SE | United Kingdom |
|
| Russells Hall Hospital | Recruiting | Dudley | DY1 2HQ | United Kingdom |
|
| Gloucestershire Royal Hospital | Recruiting | Gloucester | GL1 3NN | United Kingdom |
|
| Hull Royal Infirmary | Recruiting | Hull | HU3 2JZ | United Kingdom |
|
| Vascular Surgical Unit, Leeds General Infirmary | Terminated | Leeds | LS1 3EX | United Kingdom |
| St George's Hospital | Not yet recruiting | London | SW17 0QT | United Kingdom |
|
| Derriford Hospital | Recruiting | Plymouth | PL6 8HD | United Kingdom |
|
| The Willows Centre for Health | Not yet recruiting | Salford | M5 5JR | United Kingdom |
|
| Arrowe Park Hospital | Recruiting | Upton | CH49 5PE | United Kingdom |
|
| Wrexham Maelor Hospital | Recruiting | Wrexham | LL13 7TD | United Kingdom |
|
| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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