Conditions: Diabetes Mellitus Peripheral Neuropathy Plantar Ulcers
Keywords: Diabetes mellitus plantar ulcers peripheral neuropathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 17
Healthy volunteers: no

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.

Detailed description:
Please read "Brief Summary"

Arms:
arm 1: Placebo (saline) injections into 6 sites in the calf muscle arm 2: Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles. arm 3: 300 units of botulinum toxin injected into 6 sites in the calf muscle

Interventions: intervention 1: Botulinum Toxin intervention 2: Saline
Intervention descriptions: intervention 1: 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 intervention 2: 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

Protocol document: