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This is a Phase I, double blind, randomized, placebo-controlled study that will enroll approximately 50 adult subjects with Type 1 or Type 2 diabetes mellitus and chronic, diabetic foot ulcers. The study will be conducted at approximately 12 investigational sites in the United States.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhuMAb VEGF (telbermin) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of clinically significant hypotension. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of clinically significant ulcer infection defined by increased discharge and malodorous exudates from the ulcer, fever, and a white blood cell (WBC) count of >10,000/uL | ||
| Development of anti telbermin antibodies |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Breen, Ph.D. | Genentech, Inc. | Study Director |
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| ID | Term |
|---|---|
| D016523 | Foot Ulcer |
| D003920 | Diabetes Mellitus |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007871 | Leg Ulcer |
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| Incidence of adverse events |
| Percent reduction in total ulcer surface area. |
| D012883 |
| Skin Ulcer |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |