Diabetes MellitusPhase 4NCT00120341
Anodyne Therapy in Diabetic Sensory Neuropathy
A Phase 4 study testing Anodyne Therapy System in people with Diabetes Mellitus and Diabetic Neuropathy, run by Scott and White Hospital & Clinic at 1 site in United States.
Trial summary
The purpose of this research study is to determine if the use of a series of the Anodyne Therapy System in-home treatments over a 90-day period will improve peripheral sensation and quality of life in persons with diabetes mellitus. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetic Neuropathy
- What is being tested?
- Anodyne Therapy System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jun 2006
- Phase
- Phase 4
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with diabetes mellitus and peripheral sensory neuropathy.
- Subjects at least 25 years old.
- Vibration perception threshold (VPT) ≥ 20 volts and ≤ 45 volts.
- Subjects must be alert, oriented, mentally competent and able to understand and comply with the requirements of the study, and provide voluntary informed consent.
- Subjects must be willing and able to complete the required study visits and record treatment activity in the study logbook.
Who cannot join
- Subjects who have a VPT <20 or > 45 volts.
- Subjects with uncontrolled hypertension greater than 180 systolic or greater than 110 diastolic as determined by enrollment questionnaire
- Subjects who are pregnant or breastfeeding or who are likely to become pregnant during the course of the study.
- Subjects with active malignancy (including basal cell carcinoma) on the lower extremities.
- Subjects who have had prior reconstructive or replacement knee surgery with neurological deficits related to the surgery. ( If the patient has had knee surgery, their neuropathy appears to be uniform and bilateral, then they can be included in the study).
- Subjects with a history of previous back surgery, spinal stenosis, or spinal compression or radiculopathy with neurological deficits related to spinal cord pathology. ( If the patient has had back surgery, their neuropathy appears to be uniform and bilateral, then they can be included in the study).
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- Subjects who are non-ambulatory.
- Subjects with a history of neuromuscular disease, leprosy, chronic alcoholism, or sarcoidosis.
- Subjects with foot ulcerations.
- Subjects with a transmetatarsal amputation or higher
Trial locations and contacts
1 site in 1 country.
United States1 site
Scott and White Santa Fe Center
Temple, Texas, 76504
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Prospective Study to Evaluate the Effectiveness of Monochromatic Infrared Photo Energy to Improve Diabetic Sensory Neuropathy
The purpose of this research study is to determine if the use of a series of the Anodyne Therapy System in-home treatments over a 90-day period will improve peripheral sensation and quality of life in persons with diabetes mellitus.
Read the detailed description
The morbidity, direct cost and mortality associated with lower extremity complications among patients with diabetes mellitus have been well described in the medical literature. Peripheral sensory neuropathy is one of the strongest risk factors for both foot ulceration and amputation in this population. In the absence of neuropathy people rarely develop foot ulcers. Because of the lack of painful feedback, peripheral neuropathy provides a permissive environment that allows repetitive tissue injury to occur such that a person may wear a hole in the bottom of his or her foot much in the way that he or she may wear a hole in a stocking. Certainly, the early detection of a level of peripheral neuropathy sufficient to contribute to the development of foot wounds or "loss of protective sensation" is one of the most important criteria to identify high risk patients for foot complications and is paramount when instituting a structured treatment plan to prevent lower extremity complications.
The objective of the study is to determine the efficacy of the application of a series of Anodyne in-home treatments over a 90-day period to improve peripheral sensation and self-reported quality of life in persons with diabetes mellitus. This pilot study should provide preliminary data to determine if additional clinical evaluation is warranted and to determine an appropriate sample size. The hypothesis is the Anodyne therapy will improve sensory function over the course of therapy compared to sham therapy.
- Conditions
- Diabetes Mellitus, Diabetic Neuropathy
- Being tested
- Anodyne Therapy System
- Medical subject headings
- Diabetes Mellitus, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodyne Therapy SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in sensation using, vibration perception threshold testing, monofilament testing, and the Michigan Neuropathy Screening Instrument
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2005 (estimated)
- Study startApr 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Scott and White Hospital & Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Anodyne Therapy, LLC
- Investigators
- Lawrence A Lavery, DPM, Principal investigator, Scott and White Memorial Hospital & Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120341
- Sponsor's protocol ID
- 50100
- Status last verified
- May 2007
- First submitted
- 30 Jun 2005
- Last updated
- 1 Jun 2007
- Results posted
- No
Publications
Lavery LA, Murdoch DP, Williams J, Lavery DC. Does anodyne light therapy improve peripheral neuropathy in diabetes? A double-blind, sham-controlled, randomized trial to evaluate monochromatic infrared photoenergy. Diabetes Care. 2008 Feb;31(2):316-21. doi: 10.2337/dc07-1794. Epub 2007 Oct 31.
PubMed 17977931
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Prospective Study to Evaluate the Effectiveness of Monochromatic Infrared Photo Energy to Improve Diabetic Sensory Neuropathy
- ClinicalTrials.gov ID
- NCT00120341
- Acronym / sponsor ID
- 50100
- Conditions
- Diabetes Mellitus, Diabetic Neuropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Scott and White Hospital & ClinicUniversity, hospital or other
- Collaborators
- Anodyne Therapy, LLC
- Study start
- Apr 2005
- Study completion
- Jun 2006
- First posted
- 15 Jul 2005 (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 research study is to determine if the use of a series of the Anodyne Therapy System in-home treatments over a 90-day period will improve peripheral sensation and quality of life in persons with diabetes mellitus.
Detailed description
The morbidity, direct cost and mortality associated with lower extremity complications among patients with diabetes mellitus have been well described in the medical literature. Peripheral sensory neuropathy is one of the strongest risk factors for both foot ulceration and amputation in this population. In the absence of neuropathy people rarely develop foot ulcers. Because of the lack of painful feedback, peripheral neuropathy provides a permissive environment that allows repetitive tissue injury to occur such that a person may wear a hole in the bottom of his or her foot much in the way that he or she may wear a hole in a stocking. Certainly, the early detection of a level of peripheral neuropathy sufficient to contribute to the development of foot wounds or "loss of protective sensation" is one of the most important criteria to identify high risk patients for foot complications and is paramount when instituting a structured treatment plan to prevent lower extremity complications.
The objective of the study is to determine the efficacy of the application of a series of Anodyne in-home treatments over a 90-day period to improve peripheral sensation and self-reported quality of life in persons with diabetes mellitus. This pilot study should provide preliminary data to determine if additional clinical evaluation is warranted and to determine an appropriate sample size. The hypothesis is the Anodyne therapy will improve sensory function over the course of therapy compared to sham therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with diabetes mellitus and peripheral sensory neuropathy.
- Subjects at least 25 years old.
- Vibration perception threshold (VPT) ≥ 20 volts and ≤ 45 volts.
- Subjects must be alert, oriented, mentally competent and able to understand and comply with the requirements of the study, and provide voluntary informed consent.
- Subjects must be willing and able to complete the required study visits and record treatment activity in the study logbook.
Key exclusion criteria (10 listed)
- Subjects who have a VPT <20 or > 45 volts.
- Subjects with uncontrolled hypertension greater than 180 systolic or greater than 110 diastolic as determined by enrollment questionnaire
- Subjects who are pregnant or breastfeeding or who are likely to become pregnant during the course of the study.
- Subjects with active malignancy (including basal cell carcinoma) on the lower extremities.
- Subjects who have had prior reconstructive or replacement knee surgery with neurological deficits related to the surgery. ( If the patient has had knee surgery, their neuropathy appears to be uniform and bilateral, then they can be included in the study).
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 |
|---|---|---|
| Anodyne Therapy System | Device | – |
Primary outcome
changes in sensation using, vibration perception threshold testing, monofilament testing, and the Michigan Neuropathy Screening Instrument
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2007.
- Derived from this study: PubMed 17977931Lavery LA, Murdoch DP, Williams J, Lavery DC. Does anodyne light therapy improve peripheral neuropathy in diabetes? A double-blind, sham-controlled, randomized trial to evaluate monochromatic infrared photoenergy. Diabetes Care. 2008 Feb;31(2):316-21. doi: 10.2337/dc07-1794. Epub 2007 Oct 31.
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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.
Lawrence A Lavery, DPM principal investigator
Scott and White Memorial Hospital & Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anodyne Therapy System in people with Diabetes Mellitus and Diabetic Neuropathy, run by Scott and White Hospital & Clinic 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 5 inclusion and 10 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 1 Jun 2007. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
changes in sensation using, vibration perception threshold testing, monofilament testing, and the Michigan Neuropathy Screening Instrument. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00120341, which also lists 1 linked publication.
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 1 Jun 2007.