Text Size

Botulinum Toxin Effects on Plantar Ulcer Recurrence

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Mary Hastings, PT, DPT, ATC, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00845897
First received: February 16, 2009
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Peripheral Neuropathy
Plantar Ulcers
 Drug: Botulinum Toxin
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Botulinum Toxin Effects on Plantar Ulcer Recurrence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Plantar Flexor Muscle Strength [ Time Frame: Pre-treatment, 2 weeks after injection, upon ulcer healing, 3 months and 6 months after ulcer healing ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Barefoot Plantar Pressure [ Time Frame: pre-injection, 2 weeks post injection, post healing, and 3 and 6 months post healing ] [ Designated as safety issue: No ]
    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.


Enrollment: 17
Study Start Date: March 2005
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo (saline) injections into 6 sites in the calf muscle
 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
Active Comparator: 2
Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
 Drug: 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
Other Name: botox
Active Comparator: 3
300 units of botulinum toxin injected into 6 sites in the calf muscle
 Drug: 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
Other Name: botox

Detailed Description:

Please read "Brief Summary"

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845897

Locations
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Mary K Hastings, PT, DPT, ATC Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Mary Hastings, PT, DPT, ATC, Assistant Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00845897     History of Changes
Other Study ID Numbers: 04-0493, R21HD048972
Study First Received: February 16, 2009
Results First Received: August 11, 2011
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Diabetes mellitus
plantar ulcers
peripheral neuropathy

Additional relevant MeSH terms:
Diabetes Mellitus
Peripheral Nervous System Diseases
Recurrence
Ulcer
Foot Ulcer
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases
Disease Attributes
 Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013