Diabetic FootNCT05831059
A Sympathetic Ganglion, High-voltage Pulsed Radiofrequency Ablation of Peripheral Neuralgia
A study testing Pulsed radio frequency therapy in people with Diabetic Foot, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The Sham Operation Group was used as control, the patients were assessed with the Digital Rating Scale (NRS) , the quality of life-related scale (Euro Qol) , clinical outcome measures: physician's overall impression of changes in pain (CGIC) and patient's overall impression change scale (PGIC) , skin temperature… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Pulsed radio frequency therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2022to 15 Dec 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily participate in the study and sign the informed consent form;
- The age is between 18 (inclusive) and 85 (inclusive), regardless of gender;
- Body mass index (BMI) ≤ 45;
- Clinically diagnosed diabetes foot with moderate and severe pain in peripheral nerve of affected limb (defined as NRS score ≥ 4), the course of disease lasts for more than 12 months, and has been treated with clinical routine standard drugs (mecobalamin α- Lipoic acid, sodium valproate, carbamazepine, gabapentin/pregabalin, etc.) symptoms still exist at least 6 months later;
- Glycated hemoglobin<8%;
- Not participating in the drug/medical device test within 3 months before the test;
Who cannot join
- Patients who are in poor condition and cannot objectively describe symptoms or cooperate to complete the questionnaire score
- Ulcer is red and swollen, or active inflammatory infection;
- The affected limb has lesions such as blackening and gangrene of the toe skin;
- Those suffering from severe respiratory and cardiovascular diseases, liver and kidney insufficiency, and malignant tumors;
- Breast-feeding and pregnant women, or subjects with pregnancy plan within 1 month after the trial (also including male subjects);
- The daily dose of opioids is more than 120mg (different drug doses are converted into 120mg morphine sustained-release tablets);
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- People with allergic diseases and allergic constitution;
- Have a history of drug abuse or drug addiction;
- There are contraindications to pulsed radio frequency therapy;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Double-blind, Multicenter, Sympathetic Ganglion, High-voltage Pulsed Radiofrequency Ablation of Peripheral Neuralgia in Patients With Diabetic Foot
The Sham Operation Group was used as control, the patients were assessed with the Digital Rating Scale (NRS) , the quality of life-related scale (Euro Qol) , clinical outcome measures: physician's overall impression of changes in pain (CGIC) and patient's overall impression change scale (PGIC) , skin temperature measurement, toe Oxygenation measurement, and anxiety and depression scores (Gad-7, Phq-9) , objective: to evaluate the efficacy and safety of high voltage pulsed radiofrequency in the treatment of peripheral neuralgia in patients with diabetic foot.
- Conditions
- Diabetic Foot
- Being tested
- Pulsed radio frequency therapy, sham operation
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed radio frequency therapyRadiation
Pulse Radio Frequency mode is a high voltage and low temperature Radio Frequency mode formed by discontinuous and pulsed current around nerve tissue
sham operationOther
The means to achieve double-blind treatment had no practical effect on the subjects
| Study group | Role | What they receive |
|---|---|---|
| A group | Experimental | First receive pulse radio frequency treatment and then receive sham operation treatment Receives: Radiation: Pulsed radio frequency therapy; Other: sham operation |
| B group | Active comparator | First receive sham operation treatment and then receive pulse radio frequency treatment Receives: Radiation: Pulsed radio frequency therapy; Other: sham operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
Numeric Rating Scale is the most widely used one-dimensional assessment scale，The higher the number, the more severe the pain
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start12 Dec 2022
- Primary completion15 Nov 2023
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke Ma, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831059
- Sponsor's protocol ID
- XH-23-004
- Status last verified
- Apr 2024
- First submitted
- 15 Mar 2023
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-blind, Multicenter, Sympathetic Ganglion, High-voltage Pulsed Radiofrequency Ablation of Peripheral Neuralgia in Patients With Diabetic Foot
- ClinicalTrials.gov ID
- NCT05831059
- Acronym / sponsor ID
- XH-23-004
- Conditions
- Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 26 Apr 2023 (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.
The Sham Operation Group was used as control, the patients were assessed with the Digital Rating Scale (NRS) , the quality of life-related scale (Euro Qol) , clinical outcome measures: physician's overall impression of changes in pain (CGIC) and patient's overall impression change scale (PGIC) , skin temperature measurement, toe Oxygenation measurement, and anxiety and depression scores (Gad-7, Phq-9) , objective: to evaluate the efficacy and safety of high voltage pulsed radiofrequency in the treatment of peripheral neuralgia in patients with diabetic foot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | Experimental | Radiation: Pulsed radio frequency therapy, Other: sham operationFirst receive pulse radio frequency treatment and then receive sham operation treatment |
| B group | Active comparator | Radiation: Pulsed radio frequency therapy, Other: sham operationFirst receive sham operation treatment and then receive pulse radio frequency treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects voluntarily participate in the study and sign the informed consent form;
- The age is between 18 (inclusive) and 85 (inclusive), regardless of gender;
- Body mass index (BMI) ≤ 45;
- Clinically diagnosed diabetes foot with moderate and severe pain in peripheral nerve of affected limb (defined as NRS score ≥ 4), the course of disease lasts for more than 12 months, and has been treated with clinical routine standard drugs (mecobalamin α- Lipoic acid, sodium valproate, carbamazepine, gabapentin/pregabalin, etc.) symptoms still exist at least 6 months later;
- Glycated hemoglobin<8%;
Key exclusion criteria (9 listed)
- Patients who are in poor condition and cannot objectively describe symptoms or cooperate to complete the questionnaire score
- Ulcer is red and swollen, or active inflammatory infection;
- The affected limb has lesions such as blackening and gangrene of the toe skin;
- Those suffering from severe respiratory and cardiovascular diseases, liver and kidney insufficiency, and malignant tumors;
- Breast-feeding and pregnant women, or subjects with pregnancy plan within 1 month after the trial (also including male subjects);
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 |
|---|---|---|
| Pulsed radio frequency therapyPulse Radio Frequency mode is a high voltage and low temperature Radio Frequency mode formed by discontinuous and pulsed current around nerve tissue | Radiation | A group, B group |
| sham operationThe means to achieve double-blind treatment had no practical effect on the subjects | Other | A group, B group |
Primary outcome
Numeric Rating Scale
Time frame: up to 4 months
Numeric Rating Scale is the most widely used one-dimensional assessment scale，The higher the number, the more severe the pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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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?
A study testing Pulsed radio frequency therapy in people with Diabetic Foot, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 9 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 30 May 2024. 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?
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?
Numeric Rating Scale (time frame: up to 4 months). 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 30 May 2024.