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Clinical Efficacy of Spinal Cord Stimulation in Preventing Diabetic Foot Ulcers: A Multicenter Retrospective Cohort Study

Clinical Efficacy of Spinal Cord Stimulation in Preventing Diabetic Foot Ulcers: A Multicenter Retrospective Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115182
Enrollment
Unknown
Registered
2025-12-23
Start date
2025-12-24
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Diabetic Foot

Interventions

Spinal Cord Stimulation Combined with Comprehensive Medical Foot Care Group:None
Pure Comprehensive Medical Foot Care Group:None

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years and <= 80 years; 2. Diagnosed with diabetic foot at Wagner stage 0 and IWGDF risk levels 1-3, indicating high-risk factors for ulceration such as diabetic peripheral neuropathy and diabetic peripheral vascular disease; 3. No foot ulceration present at the time of diabetic foot diagnosis; 4. Underwent spinal cord electrical stimulation surgery or received comprehensive medical foot care alone between 1 January 2019 and 1 September 2022; 5. Stable glycaemic control with HbA1c levels between 6.5% and 10%.

Exclusion criteria

Exclusion criteria: 1. Patients with malignant tumours, cardiovascular or cerebrovascular diseases, or other severe underlying conditions, or those with a life expectancy of less than three years, in addition to those diagnosed with diabetic foot; 2. Patients with uncontrolled blood pressure; 3. Patients with contraindications to surgery or who cannot tolerate surgical treatment.

Design outcomes

Primary

MeasureTime frame
Presence of Foot Ulcers;

Secondary

MeasureTime frame
Skin temperature of both lower limbs;Number of lower limb arteries;Nerve conduction velocity in the lower limbs;PtcO2;Ankle-Brachial Index, ABI;Visual Analogue Scale of Pain, VAS;Modified Muscle Rating Scale, MRC;Functional Ambulation Category, FAC;Cross-sectional area of skeletal muscle at the mid-thigh level;Cross-sectional area of skeletal muscle at the mid-calf level;Soft tissue echo intensity gray scale value of the medial thigh muscle;

Countries

China

Contacts

Public ContactYao Yilong

Shengjing Hospital of China Medical University

yaoyilong_322@163.com+86 189 4025 2644

Outcome results

None listed

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