Botulinum Toxin Effects on Plantar Ulcer Recurrence

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2010-03-31

Brief Summary

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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.

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Detailed Description

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Please read "Brief Summary"

Conditions

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Diabetes Mellitus Peripheral Neuropathy Plantar Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

2

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

Group Type ACTIVE_COMPARATOR

Botulinum Toxin

Intervention Type DRUG

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

3

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

Group Type ACTIVE_COMPARATOR

Botulinum Toxin

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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botox

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No