A prospective, multicenter, randomized controlled clinical study of excimer laser ablation combined with drug-coated balloon and drug-coated balloon alone in the treatment of diabetic foot

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100048416

Enrollment

Unknown

Registered

2021-07-06

Start date

2021-08-01

Completion date

Unknown

Last updated

2022-03-14

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

Conditions

diabetic foot

Interventions

Group 1:Excimer laser combined with drug-coated balloon

Group 2:Drug-coated balloon

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Diabetes; 2. Aged 18-85 years, no gender limit; 3. The CTA of our hospital is clearly diagnosed as ASO, and the length of the lesion is =grade 5; 5. New lesions of lower extremity arteries.

Exclusion criteria

Exclusion criteria: 1. Severe renal failure (creatinine>250umol/L), pregnant women and other reasons cannot perform CTA examination; 2. Unable to sign the informed consent; 3. Patients with life expectancy < 1 year; 4. Coagulation disorders.

Design outcomes

Primary

Measure	Time frame
Procedure success;Major-amputation free survival;Clinically driven target lesion reintervention, CD-TLR;Ulcer healing;Lumen acquirement;	—

Secondary

Measure	Time frame
One-stage patency rate;	—

Countries

China

Contacts

Public ContactDong Zhihui

Zhongshan Hospital, Fudan University

dzh926@126.com+86 13564249168

Outcome results

None listed

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