Status:
COMPLETED
Botulinum Toxin Effects on Plantar Ulcer Recurrence
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Diabetes Mellitus
Peripheral Neuropathy
Eligibility:
All Genders
Phase:
NA
Brief 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, an...
Detailed Description
Please read "Brief Summary"
Eligibility Criteria
Inclusion
- Diagnosis of diabetes mellitus and determination of diminished or absent plantar sensation
- A recurrent forefoot plantar ulcer; at least the second occurrence of a plantar ulcer or a previous failure to heal a plantar ulcer with reasonable treatment intervention (Total contact casting, off loading boot, molded ankle foot orthotic, Gillette, or therapeutic footwear modifications)
- Ambulatory
Exclusion
- Active infection in the involved foot
- Previous botulinum toxin injections
- Ulcers on the dorsal surface of the foot
- Ankle-brachial index \<0.45
- History of cerebral vascular accident or other neurological problems complicating their rehabilitation
- Women of childbearing years unless pregnancy test is agreed upon, completed, and negative and agree to use some form of contraception during the study.
- Current drug therapy that includes an anticoagulant
- History of a neuromuscular disease, except peripheral neuropathy as a result of diabetes mellitus
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00845897
Start Date
March 1 2005
End Date
March 1 2010
Last Update
February 3 2012
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63108