Painful Diabetic Peripheral NeuropathySCOPENCT03520608
Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnt
An observational study of Painful Diabetic Peripheral Neuropathy, run by Peking University Third Hospital at 1 site in China.
Trial summary
Painful Diabetic peripheral Neuropathy Study of Chinese OutPatiEnt (PDN-SCOPE): a multi-center cross-sectional registry study of clinical characteristics and treatment survey of PDN in China Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Diabetic Peripheral Neuropathy
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 1 May 2019
- 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: approximately 1500 Chinese PDN outpatient patients were required
Who may be able to join
- 18 years of age or older patients
- definite diagnosis of type I and type II diabetes
- evidence of symptoms, signs and/or electrophysiology of diabetic peripheral neuropathy
- complains of spontaneous pain (continuous or intermittent needle pricking, electric pain, burning pain etc.) or induced pain (hypersensitivity, sensory inversion).
- the pain lasts for at least 3 months
- signed informed consent
Who cannot join
- other causes of neuropathic pain, non-neuropathic pain or mixed pain, such as neck / lumbar degenerative disease, arthritis, nerve root compression, para-neoplastic syndrome, cerebrovascular disease, spinal cord diseases and other peripheral neuropathy (immunity, toxic and nutritional neuropathy etc.)
- dementia, substance abuse etc. and other conditions seriously affecting cognitive and communication skills
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dongsheng Fan
Beijing, Beijing Municipality, 100191
Dongsheng Fan, MD, +861082265694, dsfan@sina.com
About this study
Official title: Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnt (PDN-SCOPE): a Multi-center Cross-sectional Registry Study of Clinical Characteristics and Treatment Survey of PDN in China
Painful Diabetic peripheral Neuropathy Study of Chinese OutPatiEnt (PDN-SCOPE): a multi-center cross-sectional registry study of clinical characteristics and treatment survey of PDN in China
Read the detailed description
Painful diabetic peripheral neuropathy (PDN) presents a serious health problem in China. SCOPE is a cross-sectional, multi-centers registry study with a target sample size of 1500 patients who are experiencing PDN. The patients are treated following guideline and local practice. Real-world data including demographics, medical histories, VAS, PHQ, GAD -7 and therapies are collected. The primary objective is to analyze the clinical characteristics of PDN. The secondary objectives include anxiety depression distribution and current treatment status.The SCOPE study will help to find actual clinical manifestation and treatment and improve the overall treatment outcome of Chinese patients with PDN.
- Conditions
- Painful Diabetic Peripheral Neuropathy
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalnce of irrational use of pain reliever drugs
percent
Measured: baseline
Secondary outcomes (4)
Douleur Neuropathique4 questions(DN4)
unit
Measured: baseline
Visual Analogue Score(VAS)
1 to 10 units are minimum to maximum scores. Higher values represent a worse outcome of pain.
Measured: baseline
Patient Health Questionnaire(PHQ-9)
0 to 27 units are minimum to maximum scores. Higher values represent a worse outcome of depression.
Measured: baseline
Generalized Anxiety Disorder Screener (GAD-7)
0 to 21 units are minimum to maximum scores. Higher values represent a worse outcome of anxiety.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 May 2018 (estimated)
- Primary completion1 Nov 2018 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Painful Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fan Dongsheng, Peking University Third Hospital
- Investigators
- Dongsheng Fan, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520608
- Sponsor's protocol ID
- 2018182
- Acronym
- SCOPE
- Status last verified
- Apr 2018
- First submitted
- 9 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang Y, Zhang S, Pan L, Wang B, Sun Y, Gao L, Wang L, Cui L, Zhang Q, Shang H, Jin S, Qin X, Geng D, Yu X, Yang L, Li L, Li Z, Yan C, Sun H, Sun T, Du B, Cao J, Hu F, Ma J, Zhou S, Zhao F, Li W, Zheng J, Yi Y, Xu J, Hu B, Sheng B, Li Z, Zhao Z, Yang T, Wang N, Zhao H, Mima D, Qu H, Wang Y, Song F, Li X, Li N, Fan D. Painful Diabetic Peripheral Neuropathy Study of Chinese Outpatients (PDNSCOPE): A Multicentre Cross-Sectional Registry Study of Clinical Characteristics and Treatment in Mainland China. Pain Ther. 2021 Dec;10(2):1355-1373. doi: 10.1007/s40122-021-00281-w. Epub 2021 Aug 7.
PubMed 34363598Zhang Y, Li N, Zhao Y, Fan D. Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnts (PDN-SCOPE): protocol for a multicentre cross-sectional registry study of clinical characteristics and treatment in China. BMJ Open. 2019 Apr 8;9(4):e025722. doi: 10.1136/bmjopen-2018-025722.
PubMed 30962233
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnt (PDN-SCOPE): a Multi-center Cross-sectional Registry Study of Clinical Characteristics and Treatment Survey of PDN in China
- ClinicalTrials.gov ID
- NCT03520608
- Acronym / sponsor ID
- SCOPE / 2018182
- Conditions
- Painful Diabetic Peripheral Neuropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 11 May 2018 (actual)
- 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.
Painful Diabetic peripheral Neuropathy Study of Chinese OutPatiEnt (PDN-SCOPE): a multi-center cross-sectional registry study of clinical characteristics and treatment survey of PDN in China
Detailed description
Painful diabetic peripheral neuropathy (PDN) presents a serious health problem in China. SCOPE is a cross-sectional, multi-centers registry study with a target sample size of 1500 patients who are experiencing PDN. The patients are treated following guideline and local practice. Real-world data including demographics, medical histories, VAS, PHQ, GAD -7 and therapies are collected. The primary objective is to analyze the clinical characteristics of PDN. The secondary objectives include anxiety depression distribution and current treatment status.The SCOPE study will help to find actual clinical manifestation and treatment and improve the overall treatment outcome of Chinese patients with PDN.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- approximately 1500 Chinese PDN outpatient patients were required
Key inclusion criteria (6 listed)
- 18 years of age or older patients
- definite diagnosis of type I and type II diabetes
- evidence of symptoms, signs and/or electrophysiology of diabetic peripheral neuropathy
- complains of spontaneous pain (continuous or intermittent needle pricking, electric pain, burning pain etc.) or induced pain (hypersensitivity, sensory inversion).
- the pain lasts for at least 3 months
Key exclusion criteria (2 listed)
- other causes of neuropathic pain, non-neuropathic pain or mixed pain, such as neck / lumbar degenerative disease, arthritis, nerve root compression, para-neoplastic syndrome, cerebrovascular disease, spinal cord diseases and other peripheral neuropathy (immunity, toxic and nutritional neuropathy etc.)
- dementia, substance abuse etc. and other conditions seriously affecting cognitive and communication skills
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
prevalnce of irrational use of pain reliever drugs
Time frame: baseline
percent
4 secondary outcomes
Douleur Neuropathique4 questions(DN4)
Time frame: baseline
Visual Analogue Score(VAS)
Time frame: baseline
Patient Health Questionnaire(PHQ-9)
Time frame: baseline
Generalized Anxiety Disorder Screener (GAD-7)
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Derived from this study: PubMed 34363598Zhang Y, Zhang S, Pan L, Wang B, Sun Y, Gao L, Wang L, Cui L, Zhang Q, Shang H, Jin S, Qin X, Geng D, Yu X, Yang L, Li L, Li Z, Yan C, Sun H, Sun T, Du B, Cao J, Hu F, Ma J, Zhou S, Zhao F, Li W, Zheng J, Yi Y, Xu J, Hu B, Sheng B, Li Z, Zhao Z, Yang T, Wang N, Zhao H, Mima D, Qu H, Wang Y, Song F, Li X, Li N, Fan D. Painful Diabetic Peripheral Neuropathy Study of Chinese Outpatients (PDNSCOPE): A Multicentre Cross-Sectional Registry Study of Clinical Characteristics and Treatment in Mainland China. Pain Ther. 2021 Dec;10(2):1355-1373. doi: 10.1007/s40122-021-00281-w. Epub 2021 Aug 7.
- Derived from this study: PubMed 30962233Zhang Y, Li N, Zhao Y, Fan D. Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnts (PDN-SCOPE): protocol for a multicentre cross-sectional registry study of clinical characteristics and treatment in China. BMJ Open. 2019 Apr 8;9(4):e025722. doi: 10.1136/bmjopen-2018-025722.
Related trials for Painful Diabetic Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
RecruitingObservational study
Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
Painful Diabetic Peripheral Neuropathy, Diabetes Complication
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Not yet recruitingPhase 4
Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
Painful Diabetic Neuropathy (PDN), Diabetic Nephropathies
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.
Dongsheng Fan principal investigator
Peking University Third Hospital
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 Painful Diabetic Peripheral Neuropathy, run by Peking University Third Hospital at 1 site in China.
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 6 inclusion and 2 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 11 May 2018. 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 China. 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 Dongsheng Fan (+8601082265024, dsfan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalnce of irrational use of pain reliever drugs (time frame: baseline). 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 NCT03520608, which also lists 2 linked publications.
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 11 May 2018.