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A multicenter clinical study on the efficacy and safety of spinal cord electrical stimulation device implantation in the treatment of lower limb complications associated with diabetes

A multicenter clinical study on the efficacy and safety of spinal cord electrical stimulation device implantation in the treatment of lower limb complications associated with diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062681
Enrollment
Unknown
Registered
2022-08-15
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes mellitus

Interventions

case series:Spinal nerve stimulator implantation

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. Regardless of gender; 3. Diagnosed with type 1 or type 2 diabetes; 4. There are clear diabetes related lower limb complications (DRLEC), including drug refractory lower limb pain, skin temperature reduction, skin ulcer and other symptoms; 5. Blood glucose control is relatively stable; 6. Agree to abide by all conditions of the study in good faith and participate in all necessary learning, training and evaluation; 7. The patient and / or major family members sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Combined with brain cognitive impairment / epilepsy / mental disease, unable to cooperate with surgery; 2. Those who have contraindications to MRI, including pacemakers; 3. Patients who need diathermy and other treatment; 4. Hematological diseases, increased risk of surgical intervention (increased risk of bleeding events); 5. Congenital or acquired lower limb abnormalities (joint and bone effects); 6. Pregnancy; 7. The patient has other anatomical or comorbidity conditions, which may limit the patient's ability to participate in the study or comply with the follow-up requirements, or affect the scientific rationality of the research results after the evaluation of the researcher; 8. Patients who are not expected to complete the follow-up.

Design outcomes

Primary

MeasureTime frame
Lower limb skin temperature;Percutaneous oxygen partial pressure monitoring;

Secondary

MeasureTime frame
MRI (lower limbs);Pain assessment;

Countries

China

Contacts

Public ContactWangy Yi

Tianjin Medical University General Hospital

sinuosiwo@sina.com+86 13920881956

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026