Elderly diabetic foot
Conditions
Interventions
the experiment group:Excimer Laser Ablation combined with drug-coated balloon
the control group:drug-coated balloon
Sponsors
Tianjin First Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of diabetic foot; 2. Resting Ankle brachial index(ABI) <0.9; 3. CTA or color doppler ultrasound reveal that infrapopliteal artery occlusion or stenosis; 4. Diabetic foot grading: Wagner level 1-4; 5. Older than 60 years old; 6. Agreed to get into the group.
Exclusion criteria
Exclusion criteria: 1. Diabetic foot (Wagner level 0 and level 5): Wagner level 0: no ulcer, Wagner 5: severe infection up to amputation; 2. Guide wire cannot pass through diseased region, no inflow and outflow tract, cannot use endovascular treatment; 3. Refuse to use Excimer Laser Ablation (ELA); 4. Already treated by drug-coated balloon (DCB) or bypass angioplasty; 5. Has contraindication of endovascular treatment, severe organ dysfunction, renal insufficiency cannot tolerance to contrast medium, contrast medium allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target lesion patency rate in twelve months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Late lumen loss(LLL) in twelve months after surgery;Target lesion revascularization(TLR) in three month after surgery;Target lesion revascularization(TLR) in six month after surgery;Target lesion revascularization(TLR) in twelve month after surgery;Ulcer healing rate in one month after surgery;Ulcer healing rate in three month after surgery;Ulcer healing rate in six month after surgery;Ulcer healing rate in twelve month after surgery;Limb preserved rates;Adverse event rates; | — |
Countries
China
Contacts
Public ContactJu He
Tianjin First Central Hospital
Outcome results
None listed