A Study on the Efficacy and Safety of Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers With REGRANEX
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|ClinicalTrials.gov Identifier: NCT00034788|
Recruitment Status : Terminated (Slow recruitment; Study did not address safety concern raised by European Medicines Agency)
First Posted : May 3, 2002
Last Update Posted : June 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Foot Ulcer Diabetic Foot Skin Ulcer Diabetic Neuropathies||Drug: Becaplermin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multicenter Clinical Evaluation of the Efficacy and Safety of REGRANEX Gel in the Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers|
|Study Start Date :||December 2000|
|Actual Study Completion Date :||February 2004|
- Time to complete ulcer healing.
- Incidence of complete ulcer healing and reduction in total ulcer area at end of study. Incidence of adverse events throughout study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00034788
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|