MedTrace Logo

Botulinum Toxin Effects on Plantar Ulcer Recurrence

NCT00845897 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2012-02-03

Study results available
· View outcomes & findings →

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

Interventions

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

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

Sponsors & Collaborators

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

    collaborator NIH

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Mary K Hastings, PT, DPT, ATC · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00845897 on ClinicalTrials.gov