Diabetic Peripheral NeuropathyOMNIFICENTNCT01735903
Objective Measures of Nerve Integrity, Posture, Gait and Blood Flow, After Nerve Decompression
An observational study of Diabetic Peripheral Neuropathy, run by Foot Surgery Center of Northern Colorado at 1 site in United States.
Trial summary
The purpose of this study is to measure the effect of nerve decompression on the recovery of the treated nerves. To obtain objective data during surgery of the treated nerves' via electrical signals and muscle power when stimulated. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Arm A - Non-Diabetic, Gait and Balance
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Poudre Valley Foot and Ankle Clinic patients and Neuropathy Testing Center of Colorado
Who may be able to join
- Patient has been diagnosed with diabetic peripheral neuropathy and has nerve deficit in all proposed surgical areas, sensory and/or motor
- Patient has a positive provocative (i.e. Tinel's sign) observed clinically in the popliteal and tibial nerve trees.
- Patient is between 18 years and 85 years of age
- Patient is a type I or type II diabetic that is currently under medical treatment
- Patient has a Hgb A1C lab value of 8.0% or less
- Patient symptom based VAS scale is 6 or above for at least one of the following: pain, burning, numbness, tingling, weakness or instability
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- Patient is scheduled for surgery and has been cleared for outpatient surgery per anesthesia guidelines established for the Foot Surgery Center of Northern Colorado
- Patient is able and willing to comply with all study requirements, including the follow-up evaluations and will return to the investigational site for all required office visits and CSU visits
- Patient has been informed of the nature of the study, agrees to its provisions and has provided written consent
- Exclusions Criteria:
- Patient has a BMI of greater than 40 or body weight greater than 300 pounds
- Patient has untreated hypertension (systolic blood pressure > 160 and/or diastolic > 100)
- Patient's ASA is 4 or greater
- Patient has blood glucose greater than 200 the day of surgery
- Patient has Raynaud's Syndrome
- Patient is a current smoker
- Patient is a woman who is considering pregnancy or who is pregnant
- Patient has history of recent nerve or lumbar disc surgery, untreated thyroid disease, B12 or Folate deficiency, hepatic disease, renal disease, and/or Parkinson's disease, or neuropathy due to chemotherapy or radiation therapy
- Patient is being treated with chemotherapeutic agents
- Patient has ankle edema greater than mild - (Moderate to Severe)
- Patient is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Anderson Podiatry Center, Neuropathy Testing Center of Colorado
Fort Collins, Colorado, 80524
Megan L Fritz, D.C., M.S., 479-531-6133, megan.fritz.dc@gmail.com
James C. Anderson, DPM, 970-484-4620, janderson@andersonpodiatrycenter.com
About this study
Official title: Objective Measures of Nerve Integrity, Posture, Gait and Blood Flow, After Nerve Decompression In diabetiC Neuropathy PatiENTs
The purpose of this study is to measure the effect of nerve decompression on the recovery of the treated nerves. To obtain objective data during surgery of the treated nerves' via electrical signals and muscle power when stimulated. Also, to monitor muscle strength, balance/gait and blood flow in the lower extremity before and after surgery.
Read the detailed description
Nerve decompression (ND)as treatment for the foot complications of diabetic sensorimotor peripheral neuropathy (DSPN) is a controversial topic although many patients find it provides gratifying relief of pain and numbness. Neural electrical monitoring has been used intra-operatively to diagnosis nerve abnormality, monitoring for ongoing normal nerve function and confirm nerve integrity for spine surgeries and thyroid surgeries with success. Presently there is not objective data to indicate the the use of neural electrical monitoring is reliable or effective. The goal of this study is to measure objectively and quantifiable clinical surgical outcomes of nerve decompression surgery in diabetic neuropathy patients. The study is designed to measure changes in nerve function, gait, balance and blood flow in the lower limb.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Arm A - Non-Diabetic, Gait and Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm A - Non-Diabetic, Gait and BalanceProcedure or surgery
Arm A will enroll patients WITHOUT diabetes, but with peripheral neuropathy and lower limb pain, paresthesia, gait disturbances, or motor weakness and will follow the same protocol except the subject will NOT participate in blood flow testing performed at Colorado State University, and therefore do not include the inclusion/exclusion criterion that are specifically related to the blood flow assessment.
Subjects may have any combination of lower limb nerve decompression surgery of the listed surgical sites with or without the addition of Soleal Sling Decompression. Soleal Sling Decompression surgical procedure will require the use of a thigh tourniquet.
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG signals used intraoperative as objective measurements of change before and after nerve decompression surgery. Gait, balance and blood flow measurements before and after peripheral nerve decompression surgery
Primary Endpoint is assessed by changes in:
- Neuromotor function in the lower limb as measured by intraoperative electromyographic(EMG) recordings of the muscles in the anterior and lateral compartments of the leg and muscles of the foot.
- Blood flow in the lower limb both distal to and proximal to the nerve release sites, as measured by duplex doppler of the external femoral artery (a.), superficial femoral a., popliteal a., anterior and posterior tibial a., dorsal pedis a. Shear stress changes in these arteries.
- Lower limb performance defined as:
- Dorsiflexor strength and speed of contraction
- Proprioception at the ankle
- One-legged standing balance
- Functional reach
- Sensory function in the foot
- Usual gait speed
- Standardized tests of mobility
Measured: Within one month of surgical date, surgical date, 3 months and 6 months post operative or 4 months postoperative if the subjects elect to have the contralateral limb surgery prior to 3 months following the initial surgery.
Secondary outcomes (1)
Change in sensory perception
- Two-point discrimination
- Changes in nerve conduction measures
- Changes in ankle-brachial index (ABI)
- Visual Analog Score (VAS) for neuropathic symptoms
Measured: up to one month of surgical date, 3 months and 6 months post operative or 4 months postoperative if the subjects elect to have the contralateral limb surgery prior to 3 months following the initial surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foot Surgery Center of Northern Colorado
- Sponsor type
- University, hospital or other
- Collaborators
- Association of Extremity Nerve Surgeons
- Responsible party
- Principal investigator, James Anderson, DPM, Foot Surgery Center of Northern Colorado
- Investigators
- James C. Anderson, DPM, Principal investigator, Anderson Podiatry Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735903
- Sponsor's protocol ID
- OMNI1
- Acronym
- OMNIFICENT
- Status last verified
- Feb 2021
- First submitted
- 15 Nov 2012
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Measures of Nerve Integrity, Posture, Gait and Blood Flow, After Nerve Decompression In diabetiC Neuropathy PatiENTs
- ClinicalTrials.gov ID
- NCT01735903
- Acronym / sponsor ID
- OMNIFICENT / OMNI1
- Conditions
- Diabetic Peripheral Neuropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Foot Surgery Center of Northern ColoradoUniversity, hospital or other
- Collaborators
- Association of Extremity Nerve Surgeons
- Study start
- Nov 2012
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Not posted in the source record
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 study is to measure the effect of nerve decompression on the recovery of the treated nerves. To obtain objective data during surgery of the treated nerves' via electrical signals and muscle power when stimulated. Also, to monitor muscle strength, balance/gait and blood flow in the lower extremity before and after surgery.
Detailed description
Nerve decompression (ND)as treatment for the foot complications of diabetic sensorimotor peripheral neuropathy (DSPN) is a controversial topic although many patients find it provides gratifying relief of pain and numbness. Neural electrical monitoring has been used intra-operatively to diagnosis nerve abnormality, monitoring for ongoing normal nerve function and confirm nerve integrity for spine surgeries and thyroid surgeries with success. Presently there is not objective data to indicate the the use of neural electrical monitoring is reliable or effective. The goal of this study is to measure objectively and quantifiable clinical surgical outcomes of nerve decompression surgery in diabetic neuropathy patients. The study is designed to measure changes in nerve function, gait, balance and blood flow in the lower limb.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Poudre Valley Foot and Ankle Clinic patients and Neuropathy Testing Center of Colorado
Key inclusion criteria (21 listed)
- Patient has been diagnosed with diabetic peripheral neuropathy and has nerve deficit in all proposed surgical areas, sensory and/or motor
- Patient has a positive provocative (i.e. Tinel's sign) observed clinically in the popliteal and tibial nerve trees.
- Patient is between 18 years and 85 years of age
- Patient is a type I or type II diabetic that is currently under medical treatment
- Patient has a Hgb A1C lab value of 8.0% or less
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Arm A - Non-Diabetic, Gait and BalanceArm A will enroll patients WITHOUT diabetes, but with peripheral neuropathy and lower limb pain, paresthesia, gait disturbances, or motor weakness and will follow the same protocol except the subject will NOT participate in blood flow testing performed at Colorado State University, and therefore do not include the inclusion/exclusion criterion that are specifically related to the blood flow assessment. Subjects may have any combination of lower limb nerve decompression surgery of the listed surgical sites with or without the addition of Soleal Sling Decompression. Soleal Sling Decompression surgical procedure will require the use of a thigh tourniquet. | Procedure or surgery | – |
Primary outcome
EMG signals used intraoperative as objective measurements of change before and after nerve decompression surgery. Gait, balance and blood flow measurements before and after peripheral nerve decompression surgery
Time frame: Within one month of surgical date, surgical date, 3 months and 6 months post operative or 4 months postoperative if the subjects elect to have the contralateral limb surgery prior to 3 months following the initial surgery.
Primary Endpoint is assessed by changes in: * Neuromotor function in the lower limb as measured by intraoperative electromyographic(EMG) recordings of the muscles in the anterior and lateral compartments of the leg and muscles of the foot. * Blood flow in the lower limb both distal to and proximal to the nerve release sites, as measured by duplex doppler of the external femoral artery (a.), superficial femoral a., popliteal a., anterior and posterior tibial a., dorsal pedis a. Shear stress changes in these arteries. * Lower limb performance defined as: * Dorsiflexor strength and speed of contraction * Proprioception at the ankle * One-legged standing balance * Functional reach * Sensory function in the foot * Usual gait speed * Standardized tests of mobility
1 secondary outcome
Change in sensory perception
Time frame: up to one month of surgical date, 3 months and 6 months post operative or 4 months postoperative if the subjects elect to have the contralateral limb surgery prior to 3 months following the initial surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
James C. Anderson, DPM principal investigator
Anderson Podiatry Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Peripheral Neuropathy, run by Foot Surgery Center of Northern Colorado 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 21 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 16 Feb 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Megan L Fritz, D.C., M.S. (479-531-6133, megan.fritz.dc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMG signals used intraoperative as objective measurements of change before and after nerve decompression surgery. Gait, balance and blood flow measurements before and after peripheral nerve decompression surgery (time frame: Within one month of surgical date, surgical date, 3 months and 6 months post operative or 4 months postoperative if the subjects elect to have the contralateral limb surgery prior to 3 months following the initial surgery.). 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 16 Feb 2021.