Diabetic NeuropathyNeuropathicNCT02402361
Understanding Risk Factors and Determinants for Neuropathic Pain
An observational study of Diabetic Neuropathy, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Understanding risk factors and determinants for neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2016to 1 Mar 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200 patients with painful and non-painful diabetic neuropathy (males and females, ages ≥18) will be tested in the study performed in the Rambam Medical Center. The patients will be recruited from the neurology/diabetes clinics and by advertisement in local newspapers. No patients will be requested to withdraw from any of their medication, or to change the treatment regimen due to participation in the study.
Who may be able to join
- Patients with diabetes who are ≥18 years of age who have a diagnosis of peripheral neuropathy based on a prior clinical assessment combined with supportive clinical investigations such as abnormal nerve conduction studies, reduced intraepidermal nerve or abnormal findings on quantitative sensory testing.
- If supportive clinical investigations (as described above) are not available at entry into the study, a neuropathy disability scale ≥3 will be required.
- Patients with symptoms highly suggestive of neuropathy that in the judgment of the clinical researcher are suitable for the study even if they do not fulfill other inclusion criteria.
Who cannot join
- Subjects who are pregnant.
- Subjects with insufficient command of Hebrew to obtain consent from or to complete the study questionnaires.
- Subjects with insufficient mental capacity to obtain consent from or complete study questionnaires.
- Subjects with concurrent severe psychological or psychiatric disorders.
- Patients with moderate to severe pain form other causes that may confound assessment or reporting of pain.
- Patients with central nervous lesions, which may complicate somatosensory testing.
- Who is in the opinion of the investigator unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Understanding risk factors and determinants for neuropathic pain.
Read the detailed description
Neuropathic pain (NP) is common (population prevalence of 7-8%) and will present a rising health burden in the future. NP arises as a consequence of a disease or lesion in the somatosensory nervous system. NP results in significant morbidity, reduces quality of life and has a major deleterious impact on health in aging. However, not everyone with such a lesion develops significant neuropathic pain, and those who do develop it include a wide range of severity, impact and outcomes, and an unpredictable response to evidence-based treatment. The reason why some subjects develop neuropathic pain and others do not following the same injury is not known. Genetic variants are increasingly recognized as being important in the development of neuropathic pain. There are a number of Mendelian primary neuropathic pain disorders which act as exemplars of high impact gene variants which have in a number of cases been shown to alter primary afferent excitability. In addition genetic factors are also likely to be important as risk factors in more common acquired (or secondary) neuropathic pain disorders. So, identifying these risk factors will have a significant impact on health both in identifying vulnerable patients and potential for developing new treatment modalities. The proposed study is a part of multicenter international project under Horizons 2020 program of the European Union. Our aim is to understand pain pathophysiology in terms of risk factors and protective mechanisms ranging from molecular pathways to societal impacts. The desired impact is to provide a firm platform to improve diagnosis and stratify patients according to risk profile, employ preventive strategies and ultimately develop novel therapeutics.
Specific objectives for the study at large will be to: 1) Identify the influence of demographic, environmental/societal and clinical factors on the risk of developing and maintenance of NP. 2) To apply modern genomics to validate (using a targeted approach) and find novel (using genome wide association) genetic risk factors for NP. 3) To determine if patient stratification using physiological (sensory profile, endogenous analgesic mechanisms and nerve excitability) and psychological factors can predict NP risk and progression. 4) Development of a risk model/algorithm for (severe) NP, combining measurable genetic and environmental factors. The desired impact is to provide a firm platform to improve diagnosis and stratify patients according to risk profile, employ preventive strategies and ultimately develop novel therapeutics.
- Conditions
- Diabetic Neuropathy
- Keywords
- Neuropathic pain, Diabetic Neuropathy
- Medical subject headings
- Diabetic Neuropathies, Neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors and determinants for neuropathic pain
Identify the influence of demographic, environmental/societal and clinical factors on the risk of developing and maintenance of NP
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study start1 Apr 2016
- Primary completion30 Jul 2020
- Study completion1 Mar 2021
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 Diabetic 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402361
- Sponsor's protocol ID
- Neuropathic Pain_DM_CTIL
- Acronym
- Neuropathic
- Status last verified
- May 2021
- First submitted
- 25 Mar 2015
- Last updated
- 20 May 2021
- Results posted
- No
Publications
Topaz LS, Frid A, Granovsky Y, Zubidat R, Crystal S, Buxbaum C, Bosak N, Hadad R, Domany E, Alon T, Meir Yalon L, Shor M, Khamaisi M, Hochberg I, Yarovinsky N, Volkovich Z, Bennett DL, Yarnitsky D. Electroencephalography functional connectivity-A biomarker for painful polyneuropathy. Eur J Neurol. 2023 Jan;30(1):204-214. doi: 10.1111/ene.15575. Epub 2022 Oct 26.
PubMed 36148823
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Risk Factors and Determinants for Neuropathic Pain
- ClinicalTrials.gov ID
- NCT02402361
- Acronym / sponsor ID
- Neuropathic / Neuropathic Pain_DM_CTIL
- Conditions
- Diabetic Neuropathy
- Keywords
- Neuropathic pain, Diabetic Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 30 Mar 2015 (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.
Understanding risk factors and determinants for neuropathic pain.
Detailed description
Neuropathic pain (NP) is common (population prevalence of 7-8%) and will present a rising health burden in the future. NP arises as a consequence of a disease or lesion in the somatosensory nervous system. NP results in significant morbidity, reduces quality of life and has a major deleterious impact on health in aging. However, not everyone with such a lesion develops significant neuropathic pain, and those who do develop it include a wide range of severity, impact and outcomes, and an unpredictable response to evidence-based treatment. The reason why some subjects develop neuropathic pain and others do not following the same injury is not known. Genetic variants are increasingly recognized as being important in the development of neuropathic pain. There are a number of Mendelian primary neuropathic pain disorders which act as exemplars of high impact gene variants which have in a number of cases been shown to alter primary afferent excitability. In addition genetic factors are also likely to be important as risk factors in more common acquired (or secondary) neuropathic pain disorders. So, identifying these risk factors will have a significant impact on health both in identifying vulnerable patients and potential for developing new treatment modalities. The proposed study is a part of multicenter international project under Horizons 2020 program of the European Union. Our aim is to understand pain pathophysiology in terms of risk factors and protective mechanisms ranging from molecular pathways to societal impacts. The desired impact is to provide a firm platform to improve diagnosis and stratify patients according to risk profile, employ preventive strategies and ultimately develop novel therapeutics.
Specific objectives for the study at large will be to: 1) Identify the influence of demographic, environmental/societal and clinical factors on the risk of developing and maintenance of NP. 2) To apply modern genomics to validate (using a targeted approach) and find novel (using genome wide association) genetic risk factors for NP. 3) To determine if patient stratification using physiological (sensory profile, endogenous analgesic mechanisms and nerve excitability) and psychological factors can predict NP risk and progression. 4) Development of a risk model/algorithm for (severe) NP, combining measurable genetic and environmental factors. The desired impact is to provide a firm platform to improve diagnosis and stratify patients according to risk profile, employ preventive strategies and ultimately develop novel therapeutics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 patients with painful and non-painful diabetic neuropathy (males and females, ages ≥18) will be tested in the study performed in the Rambam Medical Center. The patients will be recruited from the neurology/diabetes clinics and by advertisement in local newspapers. No patients will be requested to withdraw from any of their medication, or to change the treatment regimen due to participation in the study.
Key inclusion criteria (3 listed)
- Patients with diabetes who are ≥18 years of age who have a diagnosis of peripheral neuropathy based on a prior clinical assessment combined with supportive clinical investigations such as abnormal nerve conduction studies, reduced intraepidermal nerve or abnormal findings on quantitative sensory testing.
- If supportive clinical investigations (as described above) are not available at entry into the study, a neuropathy disability scale ≥3 will be required.
- Patients with symptoms highly suggestive of neuropathy that in the judgment of the clinical researcher are suitable for the study even if they do not fulfill other inclusion criteria.
Key exclusion criteria (7 listed)
- Subjects who are pregnant.
- Subjects with insufficient command of Hebrew to obtain consent from or to complete the study questionnaires.
- Subjects with insufficient mental capacity to obtain consent from or complete study questionnaires.
- Subjects with concurrent severe psychological or psychiatric disorders.
- Patients with moderate to severe pain form other causes that may confound assessment or reporting of pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk factors and determinants for neuropathic pain
Time frame: 4 years
Identify the influence of demographic, environmental/societal and clinical factors on the risk of developing and maintenance of NP
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 20 May 2021.
- Derived from this study: PubMed 36148823Topaz LS, Frid A, Granovsky Y, Zubidat R, Crystal S, Buxbaum C, Bosak N, Hadad R, Domany E, Alon T, Meir Yalon L, Shor M, Khamaisi M, Hochberg I, Yarovinsky N, Volkovich Z, Bennett DL, Yarnitsky D. Electroencephalography functional connectivity-A biomarker for painful polyneuropathy. Eur J Neurol. 2023 Jan;30(1):204-214. doi: 10.1111/ene.15575. Epub 2022 Oct 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neuropathy, run by Rambam Health Care Campus at 1 site in Israel.
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 7 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 20 May 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 Israel. 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?
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?
Risk factors and determinants for neuropathic pain (time frame: 4 years). 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 NCT02402361, 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 20 May 2021.