N/A
Completed N=17
Botulinum Toxin Effects on Plantar Ulcer Recurrence
Diabetes · peripheral neuropathy · Plantar Ulcers
Source: ClinicalTrials.gov NCT00845897 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcomePrimary: Plantar Flexor Muscle Strength — -8; 3; 6 Plantar Flexor Torque (Nm)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plantar Flexor Muscle Strength |
-8; 3; 6 | — |
| SECONDARY Barefoot Plantar Pressure |
-4; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00845897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.