Refractory Diabetic Foot Neuropathic PainNCT07740707
Short-term SCS for Refractory Diabetic Foot Neuropathic Pain
A study testing Standardized Routine Diabetic Foot Therapy and Standard Routine Therapy + 14-day Short-term Spinal Cord Stimulation in people with Refractory Diabetic Foot Neuropathic Pain, run by Nanchong Central Hospital.
Trial summary
This single-center, assessor-blinded randomized controlled trial enrolls 88 patients with drug-refractory diabetic foot neuropathic pain unsuitable for revascularization surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Diabetic Foot Neuropathic Pain
- What is being tested?
- Standardized Routine Diabetic Foot Therapy and Standard Routine Therapy + 14-day Short-term Spinal Cord Stimulation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥18 years;
- Confirmed type 2 diabetes mellitus, Wagner grade 1-3 diabetic foot;
- Persistent moderate-to-severe neuropathic pain (Numeric Rating Scale, NRS ≥4) after ≥3 months of standardized conservative treatment including glycemic control, neurotrophic drugs, multi-modal analgesia and wound care;
- Contraindications to lower extremity revascularization surgery, persistent pain after revascularization, or voluntary refusal of vascular surgery;
- Clear consciousness, capable of completing scale assessments and multi-timepoint follow-up;
- Voluntary participation with signed written informed consent.
Who cannot join
- Spinal deformity, spinal infection, intraspinal tumor or history of spinal surgery, precluding epidural electrode implantation;
- Severe coagulation disorders, systemic infection or uncontrolled severe active foot infection;
- Severe dysfunction of heart, liver, kidney or respiratory system, unable to tolerate minimally invasive operation;
- Previous spinal cord stimulation or peripheral nerve destructive surgery;
- Psychiatric disorders interfering with assessment and follow-up cooperation;
- Pregnant or lactating women;
- Concurrent enrollment in other clinical trials targeting diabetic foot or chronic pain interventions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Randomized Controlled Study on 14-day Short-term Spinal Cord Stimulation Minimally Invasive Intervention for Patients With Refractory Diabetic Foot Neuropathic Pain
This single-center, assessor-blinded randomized controlled trial enrolls 88 patients with drug-refractory diabetic foot neuropathic pain unsuitable for revascularization surgery. Participants are randomized 1:1 to receive standard diabetic foot care alone (control) or standard care plus 14-day short-term spinal cord stimulation (intervention). The primary outcome is pain remission rate at 6 months, with repeated assessments of microcirculation, nerve function, quality of life and adverse events over 6 months. This study evaluates the efficacy and safety of short-term spinal cord stimulation and develops standardized clinical protocols for this minimally invasive therapy.
- Being tested
- Standardized Routine Diabetic Foot Therapy, Standard Routine Therapy + 14-day Short-term Spinal Cord Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Routine Diabetic Foot TherapyDrug
No spinal cord stimulation intervention; unified comprehensive clinical management throughout follow-up:
- Precise glycemic control: Adjustment of oral hypoglycemic agents or insulin, regular HbA1c monitoring;
- Basic medication: Neurotrophic agents, lower limb microcirculation improvers, stepwise multi-modal analgesics;
- Standardized wound care: Debridement, dressing change and foot decompression;
- Health education: Diabetic diet guidance, foot self-care training and individualized exercise advice;
- Unified follow-up visits at 14 days, 1 month, 3 months and 6 months for indicator detection and adverse event documentation.
Standard Routine Therapy + 14-day Short-term Spinal Cord StimulationProcedure or surgery
All routine management identical to the control group, with additional 14-day reversible epidural SCS intervention:
- Epidural electrode implantation targeting T10-T12 spinal segments under local anesthesia;
- Standardized stimulation parameters set in accordance with domestic clinical guidelines for spinal cord stimulation; electrodes retained for 14 days and removed after the intervention period;
- Identical follow-up schedule and assessment indicators as the control group.
| Study group | Role | What they receive |
|---|---|---|
| Standard Routine Therapy + 14-day Short-term Spinal Cord Stimulation | Experimental | Patients received stSCS in addition to standard routine therapy Receives: Procedure: Standard Routine Therapy + 14-day Short-term Spinal Cord Stimulation |
| Standardized Routine Diabetic Foot Therapy | Experimental | Patients receive standardized routine treatment for diabetic foot Receives: Drug: Standardized Routine Diabetic Foot Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) score
The primary outcome was pain intensity measured by the NRS(0-10) recorded at baseline, immediately after stimulation termination (study group)/at the corresponding time point after treatment (control group), and at 1, 3, and 6 months post-treatment. The proportions of patients with an NRS reduction of ≥30% and ≥50% from baseline were also recorded, with the latter defined as treatment response.
NRS ranges from 0 (no pain) to 10 (worst possible pain). Higher scores indicate worse pain.
Measured: Six months
Secondary outcomes (3)
Change in Sleep Quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
The PSQI total score ranges from 0 to 21. Higher scores indicate worse sleep quality
Measured: Six months
Change in Physical Health assessed by the 36-Item Short Form Health Survey Physical Component Summary (SF-36 PCS)
The SF-36 PCS score ranges from 0 to 100. Higher scores indicate better physical health
Measured: Six months
Change in Mental Health assessed by the 36-Item Short Form Health Survey Mental Component Summary (SF-36 MCS)
The SF-36 MCS score ranges from 0 to 100. Higher scores indicate better mental health
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Diabetic Foot Neuropathic PainStudies 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
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanchong Central Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740707
- Sponsor's protocol ID
- 2026010
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study on 14-day Short-term Spinal Cord Stimulation Minimally Invasive Intervention for Patients With Refractory Diabetic Foot Neuropathic Pain
- ClinicalTrials.gov ID
- NCT07740707
- Acronym / sponsor ID
- 2026010
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Nanchong Central HospitalOther government
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 3 Aug 2026 (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.
This single-center, assessor-blinded randomized controlled trial enrolls 88 patients with drug-refractory diabetic foot neuropathic pain unsuitable for revascularization surgery. Participants are randomized 1:1 to receive standard diabetic foot care alone (control) or standard care plus 14-day short-term spinal cord stimulation (intervention). The primary outcome is pain remission rate at 6 months, with repeated assessments of microcirculation, nerve function, quality of life and adverse events over 6 months. This study evaluates the efficacy and safety of short-term spinal cord stimulation and develops standardized clinical protocols for this minimally invasive therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Routine Therapy + 14-day Short-term Spinal Cord Stimulation | Experimental | Procedure: Standard Routine Therapy + 14-day Short-term Spinal Cord StimulationPatients received stSCS in addition to standard routine therapy |
| Standardized Routine Diabetic Foot Therapy | Experimental | Drug: Standardized Routine Diabetic Foot TherapyPatients receive standardized routine treatment for diabetic foot |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years;
- Confirmed type 2 diabetes mellitus, Wagner grade 1-3 diabetic foot;
- Persistent moderate-to-severe neuropathic pain (Numeric Rating Scale, NRS ≥4) after ≥3 months of standardized conservative treatment including glycemic control, neurotrophic drugs, multi-modal analgesia and wound care;
- Contraindications to lower extremity revascularization surgery, persistent pain after revascularization, or voluntary refusal of vascular surgery;
- Clear consciousness, capable of completing scale assessments and multi-timepoint follow-up;
Key exclusion criteria (7 listed)
- Spinal deformity, spinal infection, intraspinal tumor or history of spinal surgery, precluding epidural electrode implantation;
- Severe coagulation disorders, systemic infection or uncontrolled severe active foot infection;
- Severe dysfunction of heart, liver, kidney or respiratory system, unable to tolerate minimally invasive operation;
- Previous spinal cord stimulation or peripheral nerve destructive surgery;
- Psychiatric disorders interfering with assessment and follow-up cooperation;
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 |
|---|---|---|
| Standardized Routine Diabetic Foot TherapyNo spinal cord stimulation intervention; unified comprehensive clinical management throughout follow-up: 1. Precise glycemic control: Adjustment of oral hypoglycemic agents or insulin, regular HbA1c monitoring; 2. Basic medication: Neurotrophic agents, lower limb microcirculation improvers, stepwise multi-modal analgesics; 3. Standardized wound care: Debridement, dressing change and foot decompression; 4. Health education: Diabetic diet guidance, foot self-care training and individualized exercise advice; 5. Unified follow-up visits at 14 days, 1 month, 3 months and 6 months for indicator detection and adverse event documentation. | Drug | Standardized Routine Diabetic Foot Therapy |
| Standard Routine Therapy + 14-day Short-term Spinal Cord StimulationAll routine management identical to the control group, with additional 14-day reversible epidural SCS intervention: 1. Epidural electrode implantation targeting T10-T12 spinal segments under local anesthesia; 2. Standardized stimulation parameters set in accordance with domestic clinical guidelines for spinal cord stimulation; electrodes retained for 14 days and removed after the intervention period; 3. Identical follow-up schedule and assessment indicators as the control group. | Procedure or surgery | Standard Routine Therapy + 14-day Short-term Spinal Cord Stimulation |
Primary outcome
Numerical Rating Scale (NRS) score
Time frame: Six months
The primary outcome was pain intensity measured by the NRS(0-10) recorded at baseline, immediately after stimulation termination (study group)/at the corresponding time point after treatment (control group), and at 1, 3, and 6 months post-treatment. The proportions of patients with an NRS reduction of ≥30% and ≥50% from baseline were also recorded, with the latter defined as treatment response. NRS ranges from 0 (no pain) to 10 (worst possible pain). Higher scores indicate worse pain.
3 secondary outcomes
Change in Sleep Quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Six months
Change in Physical Health assessed by the 36-Item Short Form Health Survey Physical Component Summary (SF-36 PCS)
Time frame: Six months
Change in Mental Health assessed by the 36-Item Short Form Health Survey Mental Component Summary (SF-36 MCS)
Time frame: Six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Routine Diabetic Foot Therapy and Standard Routine Therapy + 14-day Short-term Spinal Cord Stimulation in people with Refractory Diabetic Foot Neuropathic Pain, run by Nanchong Central Hospital.
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 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: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenguo Gao (+8618404999336, gaozhenguo0822@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) score (time frame: Six 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 3 Aug 2026.