Painful Diabetic NeuropathyNCT05624762
The Therapeutic Effect of Low-intensity Focused Ultrasound on Painful Diabetic Peripheral Neuropathy
A study testing Low-Intensity Focused Ultrasound (LIFU) in people with Painful Diabetic Neuropathy, run by Chongqing Medical University at 1 site in China.
Trial summary
Diabetic painful peripheral neuropathy (DPN) constitutes a serious threat to the outcomes of patients with diabetes. Yet, the treatments for targeting the underlying nerve damage and relieving pain are limited. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Painful Diabetic Neuropathy
- What is being tested?
- Low-Intensity Focused Ultrasound (LIFU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2022to 31 Jan 2024
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 20 and 80 years
- having diabetes based on the criteria of the World Health Organization (WHO 1999)
- Having diabetic painful neuropathy for more than 1 month but less than 5 years
- no alcohol addiction (consumption<140g/week in men and <70g/week in women)
- no history of cerebral infarction/hemorrhage or other known nervous system disease
- no active infections in the skin
Who cannot join
- having abnormalities in levels of Vitamin B12, Hemoglobin, and TSH.
- HbA1C>10%
- having moderate or severe hepatic and renal dysfunctions.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016
Qian Ge, Professor, +8619946802662, geqian@hospital.cqmu.edu.cn
About this study
Diabetic painful peripheral neuropathy (DPN) constitutes a serious threat to the outcomes of patients with diabetes. Yet, the treatments for targeting the underlying nerve damage and relieving pain are limited. The low-intensity focused ultrasound (LIFU) has been demonstrated to regulate neuronal activity without any concomitant tissue damage. Studies in animal models have shown that LIFU could protect nerve cells against inflammation and oxidative stress, as well as stimulate neurotrophic factor production. In humans, LIFU has been reported to be effective in relieving peripheral neurogenic pain caused by carpal tunnel syndrome and chemotherapy drugs. Thus, we aim to design a randomized controlled double-blind study by using LIFU. The primary endpoint is the patient's pain score (NRS), and the secondary endpoints include Neuropathy Symptom Score (NSS) and Neuropathy Deficit Score (NDS). Through this study, we anticipate establishing a new method for managing painful DPN.
Read the detailed description
Diabetic peripheral neuropathy (DPN) is a major cause of disability and mortality due to pain, loss of protective sensation, foot ulceration, amputation, and risk of falls, therefore constituting a serious threat to the outcomes of patients with diabetes and their treatment costs. The pathogenesis of DPN has been proposed as an inflammatory and oxidative stress injury in nerve cells caused by glucose and lipid metabolism disorder. Yet, the treatments for targeting the underlying nerve damage and relieving pain are limited. The widely used drugs such as Mecobalamine and Lipoic acid are not effective in some patients (about 2/3). Others, like anticonvulsant (e.g. Dabapentin), antidepressant (e.g. Duloxetine), and central opioid analgesics (e.g. Tramadol), are effective in the short-term, but they may lead to side effects for long-term use such as impairment of cognitive function, insomnia, and addiction, etc. The low-intensity focused ultrasound (LIFU) is regarded as the magnitude of ultrasonic intensity similar to or below that typically used in diagnostic ultrasound examinations. Although currently LIFU has not been applied in DPN, a number of studies have demonstrated that it can regulate neuronal activity without any concomitant tissue damage. Studies in animal models have shown that LIFU could protect nerve cells against inflammation and oxidative stress, as well as stimulate neurotrophic factor production. In humans, LIFU has been reported to be effective in relieving pain caused by carpal tunnel syndrome (Median nerve compression). Also, several studies have evidenced that cancer patients suffering from chemotherapy drug-induced peripheral neurogenic pain had significant improvement by LIFU treatment. Thus, we aim to take advantage of LIFU to treat the painful DPN. We plan to design a randomized controlled double-blind study. The primary endpoint is the patient's pain score (NRS), and the secondary endpoints include Neuropathy Symptom Score (NSS) and Neuropathy Deficit Score (NDS). Through this study, we anticipate establishing a new method for managing painful DPN.
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- Low-Intensity Focused Ultrasound (LIFU), Sham Low-Intensity Focused Ultrasound
- Keywords
- Painful Diabetic Neuropathy, low-intensity focused ultrasound
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Focused Ultrasound (LIFU)Device
LIFU device (LCA200; Chongqing Haifu Medical Technology Co., Ltd., Chongqing, China).
Sham Low-Intensity Focused UltrasoundDevice
Sham Low-Intensity Focused Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| LIFU group | Active comparator | receive LIFU therapy Receives: Device: Low-Intensity Focused Ultrasound (LIFU) |
| Control group | Sham comparator | receive sham LIFU therapy Receives: Device: Sham Low-Intensity Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
the pain score is evaluated using a numeric pain rating (0-10) scale (NRS)
Measured: 7 days
Secondary outcomes (2)
Neuropathy Symptom Score (NSS)
the NSS is determined using a questionnaire
Measured: 7 days
Neuropathy Deficit Score (NDS)
the NDS is examined by an experienced neurologist
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start7 Jul 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Ge, Chongqing Medical University
- Investigators
- Qian Ge, Professor, Study director, Department of Endocrinology, the First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624762
- Sponsor's protocol ID
- DPN-China2022
- Status last verified
- Nov 2022
- First submitted
- 15 Nov 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effect of Low-intensity Focused Ultrasound on Painful Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT05624762
- Acronym / sponsor ID
- DPN-China2022
- Conditions
- Painful Diabetic Neuropathy
- Keywords
- Painful Diabetic Neuropathy, low-intensity focused ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 22 Nov 2022 (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.
Diabetic painful peripheral neuropathy (DPN) constitutes a serious threat to the outcomes of patients with diabetes. Yet, the treatments for targeting the underlying nerve damage and relieving pain are limited. The low-intensity focused ultrasound (LIFU) has been demonstrated to regulate neuronal activity without any concomitant tissue damage. Studies in animal models have shown that LIFU could protect nerve cells against inflammation and oxidative stress, as well as stimulate neurotrophic factor production. In humans, LIFU has been reported to be effective in relieving peripheral neurogenic pain caused by carpal tunnel syndrome and chemotherapy drugs. Thus, we aim to design a randomized controlled double-blind study by using LIFU. The primary endpoint is the patient's pain score (NRS), and the secondary endpoints include Neuropathy Symptom Score (NSS) and Neuropathy Deficit Score (NDS). Through this study, we anticipate establishing a new method for managing painful DPN.
Detailed description
Diabetic peripheral neuropathy (DPN) is a major cause of disability and mortality due to pain, loss of protective sensation, foot ulceration, amputation, and risk of falls, therefore constituting a serious threat to the outcomes of patients with diabetes and their treatment costs. The pathogenesis of DPN has been proposed as an inflammatory and oxidative stress injury in nerve cells caused by glucose and lipid metabolism disorder. Yet, the treatments for targeting the underlying nerve damage and relieving pain are limited. The widely used drugs such as Mecobalamine and Lipoic acid are not effective in some patients (about 2/3). Others, like anticonvulsant (e.g. Dabapentin), antidepressant (e.g. Duloxetine), and central opioid analgesics (e.g. Tramadol), are effective in the short-term, but they may lead to side effects for long-term use such as impairment of cognitive function, insomnia, and addiction, etc. The low-intensity focused ultrasound (LIFU) is regarded as the magnitude of ultrasonic intensity similar to or below that typically used in diagnostic ultrasound examinations. Although currently LIFU has not been applied in DPN, a number of studies have demonstrated that it can regulate neuronal activity without any concomitant tissue damage. Studies in animal models have shown that LIFU could protect nerve cells against inflammation and oxidative stress, as well as stimulate neurotrophic factor production. In humans, LIFU has been reported to be effective in relieving pain caused by carpal tunnel syndrome (Median nerve compression). Also, several studies have evidenced that cancer patients suffering from chemotherapy drug-induced peripheral neurogenic pain had significant improvement by LIFU treatment. Thus, we aim to take advantage of LIFU to treat the painful DPN. We plan to design a randomized controlled double-blind study. The primary endpoint is the patient's pain score (NRS), and the secondary endpoints include Neuropathy Symptom Score (NSS) and Neuropathy Deficit Score (NDS). Through this study, we anticipate establishing a new method for managing painful DPN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIFU group | Active comparator | Device: Low-Intensity Focused Ultrasound (LIFU)receive LIFU therapy |
| Control group | Sham comparator | Device: Sham Low-Intensity Focused Ultrasoundreceive sham LIFU therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age between 20 and 80 years
- having diabetes based on the criteria of the World Health Organization (WHO 1999)
- Having diabetic painful neuropathy for more than 1 month but less than 5 years
- no alcohol addiction (consumption<140g/week in men and <70g/week in women)
- no history of cerebral infarction/hemorrhage or other known nervous system disease
Key exclusion criteria (3 listed)
- having abnormalities in levels of Vitamin B12, Hemoglobin, and TSH.
- HbA1C>10%
- having moderate or severe hepatic and renal dysfunctions.
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 |
|---|---|---|
| Low-Intensity Focused Ultrasound (LIFU)LIFU device (LCA200; Chongqing Haifu Medical Technology Co., Ltd., Chongqing, China). | Device | LIFU group |
| Sham Low-Intensity Focused UltrasoundSham Low-Intensity Focused Ultrasound | Device | Control group |
Primary outcome
pain score
Time frame: 7 days
the pain score is evaluated using a numeric pain rating (0-10) scale (NRS)
2 secondary outcomes
Neuropathy Symptom Score (NSS)
Time frame: 7 days
Neuropathy Deficit Score (NDS)
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Qian Ge, Professor study director
Department of Endocrinology, the First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Intensity Focused Ultrasound (LIFU) in people with Painful Diabetic Neuropathy, run by Chongqing Medical University 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 3 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 22 Nov 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Ge, Professor (+8619946802662, geqian@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: 7 days). 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 22 Nov 2022.