NCT00845897

Botulinum Toxin Effects on Plantar Ulcer Recurrence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

Please read "Brief Summary"

Conditions

• Diabetes Mellitus
• Peripheral Neuropathy
• Plantar Ulcers

Interventions

Type	Name	Description
DRUG	Botulinum Toxin	200 units of botulinum toxin, and 300 units of botulinum toxin. Injection are given at one session. 2 injections into the medial gastrocnemius, 2 injections into the lateral gastrocnemius, and 2 injections into the soleus
DRUG	Saline	Placebo (saline) (3cc). Injection are given at one session. 2 injections into the medial gastrocnemius, 2 injections into the lateral gastrocnemius, and 2 injections into the soleus

Timeline

• Start date: 2005-03-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-02-18
• Last updated: 2012-02-03
• Results posted: 2012-02-02

Locations

1 site across 1 country: United States