Botulinum Toxin Effects on Plantar Ulcer Recurrence

Diabetes Mellitus Clinical Trial

Official title:

Botulinum Toxin Effects on Plantar Ulcer Recurrence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845897
• Other study ID #: 04-0493
• Secondary ID: R21HD048972
• Status: Completed
• Phase: N/A
• First received: February 16, 2009
• Last updated: February 1, 2012
• Start date: March 2005
• Est. completion date: March 2010

Study information

• Verified date: February 2012
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Please read "Brief Summary"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Foot Ulcer
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Plantar Ulcers
• Ulcer

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Washington University	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Barefoot Plantar Pressure	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.	pre-injection, 2 weeks post injection, post healing, and 3 and 6 months post healing	No