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NCT00845897 · ClinicalTrials.gov registry record · NA
Botulinum Toxin Effects on Plantar Ulcer Recurrence
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT00845897: Completed NA study, sponsored by Washington University School of Medicine.
NCT00845897 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00845897, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Saline
- DRUG Botulinum Toxin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2005-03 |
| Est. Completion | 2010-03 |
| Phase | NA |
What the finished NCT00845897 record still lists
NCT00845897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT00845897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00845897 about?
NCT00845897 is a clinical study titled "Botulinum Toxin Effects on Plantar Ulcer Recurrence". 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 musc...
What is the current status of trial NCT00845897?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2005-03. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00845897?
The interventions under investigation include: Saline (DRUG), Botulinum Toxin (DRUG).
Who is sponsoring clinical trial NCT00845897?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00845897's enrollment target sits among peer trials
17 1871st of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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