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The clinical translational study of transcutaneous electrical nerve stimulator for preventing deep vein thrombosis

Manufacture of wearable smart transcutaneous electrical nerve stimulator for preventing deep vein thrombosis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049579
Enrollment
Unknown
Registered
2021-08-04
Start date
2021-02-01
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Deep vein thrombosis of lower extremities

Interventions

Test Group:Use electric stimulator
Control group:No treatment

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Chinese citizens aged 40 to 80 years old; 2. Lower limb fractures, patients with high risk of deep vein thrombosis; 3. Body mass index (BMI) 18kg/m2<BMI<34kg/m2 4. Those who do not have implanted cardiac pacemakers or metal medical devices; 5. If it is a postoperative patient, the postoperative survival is expected to be higher than 3 years; 6. Normal cardiopulmonary function 7. Agree to participate in this experiment, understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. DVT, PE, blood system disease, lower limb trauma or deformity, muscle weakness, severe gastrointestinal, liver, kidney, cardiovascular disease, wearing a pacemaker, arrhythmia, peripheral arteriovenous system disease, lower limb edema Or ulcers, diseases of the nervous system, musculoskeletal system, varicose veins of the lower limbs, skin, immune, metabolic (diabetes), mental diseases, etc.; 2. Drugs that affect the nervous system and circulatory system have been taken within 1 month before the test; 3. The general condition is poor, such as poor blood sugar control, severe malnutrition or cachexia; 4. Participated in other clinical trials within 2 months before the start of this study; 5. Organ dysfunction, any physical examination index significantly deviates from the normal value; 6. Obesity, ie BMI index >40kg/m 2 7. Have a history of blood donation in the past 2 months; 8. Allergic to the materials used in the electrode paste; 9. Those who cannot follow up on schedule or cannot cooperate with the investigator due to other reasons;

Design outcomes

Primary

MeasureTime frame
D-Dimer;Lower extremity vein ultrasound;

Countries

China

Contacts

Public ContactWang jinwu

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

jinwu_wang@163.com+86 13301773680

Outcome results

None listed

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