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A multicenter, prospective, randomized, controlled study of pentoxifying maintaining vascular patency and improving wound prognosis after interventional therapy in diabetic foot patients with severe lower extremity ischemia

A multicenter, prospective, randomized, controlled study of pentoxifying maintaining vascular patency and improving wound prognosis after interventional therapy in diabetic foot patients with severe lower extremity ischemia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058328
Enrollment
Unknown
Registered
2022-04-06
Start date
2022-03-28
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

diabetic foot

Interventions

Control group:None
Pentoxifylline group:Give pentoxifylline
Cilotazole group:Give Cilotazole

Sponsors

Chu Hsien-I Memorial Hospital, Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Diabetic foot patients; 2. Severe lower extremity ischemia (ABI<0.5, TcPO2< 20mmHg, or lower extremity ultrasound /CTA report severe stenosis (over 75%) or occlusion of lower extremity arteries; 3. Aged over 18 years.

Exclusion criteria

Exclusion criteria: 1. Acute stage of myocardial infarction and heart failure; 2. Acute stage of stroke; 3. Patients with severe renal insufficiency or dialysis; 4. Liver insufficiency (ALT>100 U); 5. Severe infection that cannot be controlled; 6. Patients who could not undergo endovascular therapy or failed endovascular therapy of lower limbs; 7. Patients unwilling to attend or unable to complete follow-up visits.

Design outcomes

Primary

MeasureTime frame
patency of artery in lower extremity;maintaining time of patency of artery in lower extremity; healing rate of foot wound;healing time of foot wound;recurrent rate of foot wound one year later;

Secondary

MeasureTime frame
amputation rate;all-cause mortality;cardiovascular and cerebrovascular event;security(adverse reaction);

Countries

China

Contacts

Public ContactXu Jun

Chu Hsien-I Memorial Hospital, Tianjin Medical University

xujun0602@163.com+86 13132019724

Outcome results

None listed

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