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This study is for subjects with a venous leg ulcer. The study is being done to determine if NEXAGON plus compression bandaging is more effective that placebo plus compression bandaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nexagon® High Dose | Experimental | Weekly applications of Nexagon® high dose in addition to compression dressings. |
|
| Nexagon® Vehicle | Placebo Comparator | Weekly applications of Nexagon® Vehicle in addition to compression dressings. |
|
| No Investigational Product | No Intervention | Weekly application of compression dressings. | |
| Nexagon® Low Dose | Experimental | Weekly applications of Nexagon® low dose in addition to compression dressings. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nexagon® Low Dose | Drug | Weekly, topical application of Nexagon® low dose used with compression dressings. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surface area reduction | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complete closure | 10 weeks | |
| Time to complete closure | 10 weeks | |
| Incidence of ulcer recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom Serena, MD | Penn North Centers For Advanced Wound Care, PA, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Foot and Ankle Specialists, LLC | Phoenix | Arizona | 85015 | United States | ||
| Aung Foot Health Clinics |
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| Nexagon® High Dose | Drug | Weekly, topical application of Nexagon® high dose used with compression dressings. |
|
| Nexagon® Vehicle | Drug | Weekly, topical application of Nexagon® Vehicle used with compression dressings. |
|
| 12 weeks post closure |
| Pain | 10 weeks |
| Incidence of adverse events | 10 weeks |
| Tucson |
| Arizona |
| 85710 |
| United States |
| Southern Arizona Limb Salvage Alliance | Tucson | Arizona | 85724 | United States |
| Bay Area Foot Care | Castro Valley | California | 94546 | United States |
| Diabetic Foot & Wound Treatment Center | El Centro | California | 92243 | United States |
| Advanced Foot Care and Clinical Research Center | Fresno | California | 93722 | United States |
| Doctor's Research Network | South Miami | Florida | 33143 | United States |
| South Florida Wound Care Group | Tamarac | Florida | 33321 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| Passavant Area Hospital | Jacksonville | Illinois | 62650 | United States |
| Advanced Foot & Ankle Center | Las Vegas | Nevada | 89119 | United States |
| Oceana Country Foot and Ankle | Toms River | New Jersey | 08753 | United States |
| St Luke's - Roosevelt Hospital Center Department of Surgery | New York | New York | 10025 | United States |
| Stonybrook Univeristy Medical Center | New York | New York | 11794 | United States |
| St. John Wound Center | Tulsa | Oklahoma | 74135 | United States |
| Penn North Center For Advanced Wound Care | Erie | Pennsylvania | 16544 | United States |
| Penn North Center For Advanced Wound Care | Kittaning | Pennsylvania | 16544 | United States |
| Center For Advanced Wound Care | Wyomissing | Pennsylvania | 19610 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75235 | United States |
| Saint Paul's Women's Center | Dallas | Texas | 75237 | United States |
| DRMC Wound Clinic | Saint Geroge | Utah | 84770 | United States |
| South Sydney Vascular Centre | Sydney | New South Wales | 2228 | Australia |
| Heidelberg Repatriation Hospital | Melbourne | Victoria | Australia |
| Awhinatina Health | Manukau | Auckland | 2110 | New Zealand |
| Dunedin Hospital | Dunedin | Otago | New Zealand |
| Dr D. Lakha | Johannesburg | Gauteng | 1829 | South Africa |
| Josha Research | Bloemfontein | 9301 | South Africa |
| Boland Ethical Research Group | Cape Town | 6850 | South Africa |
| Randles Road Medical Centre | Durban | 4091 | South Africa |
| Unitas Hospital | Johannesburg | 0157 | South Africa |
| WorthwhileClinical Trials | Johannesburg | 1500 | South Africa |
| Sunninghill Hospital | Johannesburg | 2157 | South Africa |
| Witwatersrand University Medical School | Johannesburg | 2193 | South Africa |
| GCT Mercantile Clinical Trial Centre | Port Elizabeth | 6020 | South Africa |
| ID | Term |
|---|---|
| D014456 | Ulcer |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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