Diabetes MellitusNCT00845897
Botulinum Toxin Effects on Plantar Ulcer Recurrence
A study testing Botulinum Toxin and Saline in people with Diabetes Mellitus and Peripheral Neuropathy, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Peripheral Neuropathy, Plantar Ulcers
- What is being tested?
- Botulinum Toxin and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Mar 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Please read "Brief Summary"
- Conditions
- Diabetes Mellitus, Peripheral Neuropathy, Plantar Ulcers
- Being tested
- Botulinum Toxin, Saline
- Keywords
- Diabetes mellitus, plantar ulcers, peripheral neuropathy
- Medical subject headings
- Diabetes Mellitus, Peripheral Nervous System Diseases, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum ToxinDrug
Also called botox
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
SalineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo (saline) injections into 6 sites in the calf muscle Receives: Drug: Saline |
| 2 | Active comparator | Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles. Receives: Drug: Botulinum Toxin |
| 3 | Active comparator | 300 units of botulinum toxin injected into 6 sites in the calf muscle Receives: Drug: Botulinum Toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plantar Flexor Muscle Strength
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 a negative value represents a decrease in torque.
Measured: Pre-treatment, 2 weeks after injection, upon ulcer healing, 3 months and 6 months after ulcer healing
Secondary outcomes (1)
Barefoot Plantar Pressure
Novel emed pressure platform was used for data collection. A two-step method of data collection was used and a minimum of two trials of each foot were recorded. The plantar pressure map was divided into 3 horizontal masks using Percent Mask software and peak plantar pressure was determined for the forefoot region. Results are expressed in N/cm^2.
Measured: pre-injection, 2 weeks post injection, post healing, and 3 and 6 months post healing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startMar 2005
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Mary Hastings, PT, DPT, ATC, Washington University School of Medicine
- Investigators
- Mary K Hastings, PT, DPT, ATC, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845897
- Sponsor's protocol ID
- 04-0493
- Other IDs
- R21HD048972
- Status last verified
- Feb 2012
- First submitted
- 16 Feb 2009
- Last updated
- 3 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Effects on Plantar Ulcer Recurrence
- ClinicalTrials.gov ID
- NCT00845897
- Acronym / sponsor ID
- 04-0493
- Conditions
- Diabetes Mellitus, Peripheral Neuropathy, Plantar Ulcers
- Keywords
- Diabetes mellitus, plantar ulcers, peripheral neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Mar 2005
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Posted 2 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: SalinePlacebo (saline) injections into 6 sites in the calf muscle |
| 2 | Active comparator | Drug: Botulinum ToxinTotal 200 units of Botulinum Toxin injected into 6 sites into the calf muscles. |
| 3 | Active comparator | Drug: Botulinum Toxin300 units of botulinum toxin injected into 6 sites in the calf muscle |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum ToxinAlso: botox200 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 | 2, 3 |
| SalinePlacebo (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 | Drug | 1 |
Primary outcome
Plantar Flexor Muscle Strength
Time frame: Pre-treatment, 2 weeks after injection, upon ulcer healing, 3 months and 6 months after ulcer healing
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 a negative value represents a decrease in torque.
1 secondary outcome
Barefoot Plantar Pressure
Time frame: pre-injection, 2 weeks post injection, post healing, and 3 and 6 months post healing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary K Hastings, PT, DPT, ATC principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin and Saline in people with Diabetes Mellitus and Peripheral Neuropathy, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plantar Flexor Muscle Strength (time frame: Pre-treatment, 2 weeks after injection, upon ulcer healing, 3 months and 6 months after ulcer healing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2012.