| Popis: |
This is a randomized, double-masked, placebo-controlled clinical trial. The results will not be available until the completion of enrollment and unmasking of treatment groups. Therefore, there are no results/findings to report at this juncture as we are still completing enrollment. The tasks of Funding Year 3 encompassed continued recruiting, enrollment and data collection:* 52 subjects enrolled to date for all centers* 21 subjects provided crossover treatment* Expanded recruiting advertisements to multiple national publications and websites* IRB-approved recruitment letters sent to prospective subjects* Amputee support group outreach, prosthetics groups outreach, and clinic outreach conducted* Data collection ongoing for all enrolled subjects* Re-budgeted among enrolling sites due to uneven enrollment* Completed the first interim analysis after 32 subjects (results remained masked for treatment group and revealed only to the DSMB, which recommended continuing with enrollment) |
