Botulinum Toxin Effects on Plantar Ulcer Recurrence

The Washington University

Status: Completed

Conditions: Peripheral Neuropathy; Diabetes Mellitus; Plantar Ulcers

Treatments: Drug: Saline; Drug: Botulinum Toxin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00845897

04-0493

R21HD048972 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Please read "Brief Summary"

Enrollment: 17 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo (saline) injections into 6 sites in the calf muscle

Treatment:

Drug: Saline

2

Active Comparator group

Description:

Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.

Treatment:

Drug: Botulinum Toxin

3

Active Comparator group

Description:

300 units of botulinum toxin injected into 6 sites in the calf muscle

Treatment:

Drug: Botulinum Toxin