Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT00566657
Brief Summary:
Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin lesions.
Secondary objectives are to evaluate:
* The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major amputation;
* The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death;
* The safety of riferminogene pecaplasmid in the study population.
Detailed Description:
The study consists in 6-week treatment then a follow-up period up to 12 months. A follow-up contact is then scheduled 6 months later.
Per protocol amendment a 18-month long-term safety survey was added.
Study:
NCT00566657
Study Brief:
Protocol Section:
NCT00566657