Botulinum Toxin Effects on Plantar Ulcer Recurrence

NCT00845897 | Completed Results DMC

• 2 other identifiers: 04-0493R21HD048972
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Peripheral Neuropathy; Plantar Ulcers

Keywords

Diabetes mellitus; plantar ulcers; peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• Plantar Flexor Muscle Strength

  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.

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

Secondary Outcomes (1)

• Barefoot Plantar Pressure

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

Study Arms (3)

1

PLACEBO COMPARATOR

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

Drug: Saline

2

ACTIVE COMPARATOR

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

Drug: Botulinum Toxin

3

ACTIVE COMPARATOR

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

Drug: Botulinum Toxin

Interventions

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

Also known as: botox

2; 3

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

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Washington University

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Peripheral Nervous System Diseases; Foot Ulcer

Interventions

Botulinum Toxins; Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neuromuscular Diseases; Nervous System Diseases; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Mary Hastings PT, DPT, ATC
• Organization: Washington University School of Medicine

hastingsmk@wustl.edu

314 286 1433

Study Officials

• Mary K Hastings, PT, DPT, ATC

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 16, 2009
• First Posted: February 18, 2009
• Study Start: March 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 3, 2012
• Results First Posted: February 2, 2012

Record last verified: 2012-02

Locations

US (1)