N/A N=17 Randomized Quadruple-blind Treatment

Botulinum Toxin Effects on Plantar Ulcer Recurrence

Diabetes Mellitus · Peripheral Neuropathy · Plantar Ulcers

Bottom Line

View on ClinicalTrials.gov: NCT00845897 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2012

Primary outcome: Primary: Plantar Flexor Muscle Strength — -8; 3; 6 Plantar Flexor Torque (Nm)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Botulinum Toxin (Drug); Saline (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Plantar Flexor Muscle Strength	-8; 3; 6	—
SECONDARY Barefoot Plantar Pressure	-4; 0; 0	—

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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00845897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.