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Application of hemodynamically guided 3D printed insoles in patients with severe lower limb ischemia

Application of hemodynamically guided 3D printed insoles in patients with severe lower limb ischemia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051857
Enrollment
Unknown
Registered
2021-10-07
Start date
2021-10-11
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Severe lower limb ischemia

Interventions

Experimental group:Therapeutic Foot Pad Care
Control group:Routine care

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. ABI index <= 0.4 or ankle pressure < 40-50 mmHg, with or without severe lower extremity ischemia; 2. Able to walk independently; 3. Aged 18-80 years, gender is not limited; 4. Those who are willing to participate in the research of this project and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Unsteady walking caused by other reasons such as central disease; 2. Confirmation of no occlusion of lower extremity arteries by CTA and DSA; 3. A history of amputation; 4. Severe heart and lung insufficiency, affecting walking; 5. Those who participate in other projects at the same time; 6. Those who cannot complete the follow-up.

Design outcomes

Primary

MeasureTime frame
Ankle-hindfoot rating scale;

Secondary

MeasureTime frame
The time when the ulcer finally completes healing;Percentage of new ulcer or gangrene cases;Quality of life questionnaire;Rutherford score;

Countries

China

Contacts

Public ContactCheng Yong

Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

cy7107@163.com+86 13918926610

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026