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Completed

NCT Number: NCT00845897

Botulinum Toxin Effects on Plantar Ulcer Recurrence

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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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Foot Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Peripheral Neuropathy Plantar Ulcers Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University

St Louis, Missouri, 63108, United States

About this study

Please read "Brief Summary"

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin

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

Other names: botox

Saline

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

Primary outcomes

  1. Plantar Flexor Muscle Strength

    Time frame: Pre-treatment, 2 weeks after injection, upon ulcer healing, 3 months and 6 months after ulcer healing

    Concentric plantar flexor torque was assessed using the Biodex System 3 Pro Orthopedic Testing & Rehabilitation dynamometer. Plantar flexor peak torque was measured at 60 deg/sec, which is comparable to the angular velocity of the ankle joint during the stance phase of walking. Three trials of each foot were completed. Peak torque was calculated as the average of the two highest torque values across trials and results were expressed as Nm. A positive value represents an increase in torque while a negative value represents a decrease in torque.

Secondary outcomes

  1. Barefoot Plantar Pressure

    Time frame: pre-injection, 2 weeks post injection, post healing, and 3 and 6 months post healing

    Novel emed pressure platform was used for data collection. A two-step method of data collection was used and a minimum of two trials of each foot were recorded. The plantar pressure map was divided into 3 horizontal masks using Percent Mask software and peak plantar pressure was determined for the forefoot region. Results are expressed in N/cm^2.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Feb 18, 2009
Registry last updated
Feb 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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