diabetic foot
Conditions
Interventions
spinal cord stimulation group:spinal cord stimulation+clinical routine treatment
clinical routine treatment group:clinical routine treatment
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Subjects can understand and voluntarily endorse informed consent; 2) Patients who have been diagnosed with type 1 diabetes or type 2 diabetes, aged=18 years male or female; 3) Patients who have diabetic neuropathy or vascular disease and have been diagnosed of diabetic foot, according to the diabetic foot screening system; 4) Patients who still have a moderate to severe pain(VAS=4) after clinical routine treatment and vascular reconstruction therapy. 5) Patients who can be able to follow the therapy and the follow-up plan; 6) Patients who can objectively describe the symptoms, can take the initiative to cooperate, without any mental illness.
Exclusion criteria
Exclusion criteria: 1) Myocardial infarction within 3 months; unstable angina, severe cardiopulmonary insufficiency; 2) Uncontrollable diseases such as severe hypertension or diabetes; 3) Personality disorder or psychological instability; unable to collaborate; 4) Pregnancy or lactation; 5) With implantable cardioverter defibrillator (ICD) or pacemaker dependent; 6) Local infection or puncture site with skin lesions; 7) Electrode can not be implanted due to severe spinal anatomy abnormal; 8) Coagulation dysfunction, immunodeficiency; oral anticoagulants can not stop for 10 days during electrode implantation period for patients who is under anticoagulant treatment; 9) Drug dependent patients; 10) Life expectancy is less than 12 months due to coexisting disease; 11) With upper limb neuropathic pain, resting pain is greater than 3 points at the same time; 12) Recently used neuromodulation therapy less than 1 month; 13) The ankle pressure is untouchable, the deep ulcer, osteomyelitis, dry gangrene greater than 3cm2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual analogue scale(VAS); | — |
Secondary
| Measure | Time frame |
|---|---|
| short-form McGill pain questionnaire (SF-MPQ);Pittsburgh Sleep Quality Index(PSQI);Transcutaneous oxygen pressure (TcPO2);amputation;Ulcer healing;Analgesic dose;Complications of entire follow-up period; | — |
Countries
China
Contacts
Public ContactWang Yaping
The Second Xiangya Hospital of Central South University
Outcome results
None listed