At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of diabetes mellitus with diminished or absent plantar sensation
- ✓Recurrent forefoot plantar ulcer (at least second occurrence or previous failure to heal despite standard treatments)
- ✓Ambulatory status
- ✕Active infection in the involved foot
- ✕Previous botulinum toxin injections
- ✕Ulcers on the dorsal surface of the foot
- ✕Ankle-brachial index <0.45 (severe arterial insufficiency)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Botulinum Toxin Effects on Plantar Ulcer Recurrence
In Brief
A clinical study evaluating Botulinum Toxin and Saline for Diabetes Mellitus and 2 related conditions. Completed, enrolled 17 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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
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