drugset / Trial / NCT00845897

Botulinum Toxin Effects on Plantar Ulcer Recurrence

NCT00845897

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this grant is to collect pilot data to assess the amount of botulinum toxin that needs to be injected into the calf muscles of subjects with diabetes mellitus, peripheral neuropathy, and a plantar ulcer to decrease muscle strength. We hypothesize that a decrease in plantar flexor muscle strength will temporarily decrease plantar pressure. The decrease in plantar pressure will provide temporary protection to the new tissue as it gains tolerance to high stress with the long term potential outcome as a decrease in the ulcer recurrence rate.

Timeline

Start
2005-03
Primary completion
2010-03
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin Protein / enzyme biologic 200 iu Intramuscular
Comparator Botulinum toxin Protein / enzyme biologic 300 iu Intramuscular