Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 332
- Locations
- 1
- Primary Endpoint
- Healing rate of wound surface
Study Overview
Brief Summary
This cohort study aims to evaluate the outcomes of appropriate surgical treatment strategies in diabetic foot ulcers with different rate of popliteal artery stenosis(<50% or ≥50%). In this study, patients with Texas university grade 2-4(stage C-D) ischemic diabetic foot ulcers will be included. Data of patients who underwent surgical treatment in the past will be retrospectively collected. The patients with follow-up time less than 12 months will continue to follow up. Also the postoperative patients will be prospectively collected. Effects of different surgical strategies, including wound healing therapy, interventional therapy and tibial transverse bone transport therapy will be measured by several indexes.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with diabetic foot, according to "Chinese Guidelines for Diagnosis and Treatment of Diabetic Foot (2017)".
- •Texas university grade 2-4(stage C-D) ischemic diabetic foot ulcers.
- •Have clear consciousness, not suffer from mental illness, can cooperate in research and treatment.
- •Patients who are informed, participate in the research voluntarily, and have signed the informed consent.
- •Have complete clinical data.
Exclusion Criteria
- •Patients with severe systemic infection, who need to be amputated immediately to save lives.
- •Patients with mental illness, who cannot cooperate to complete the adjustment and nursing of the external fixator.
- •Patients with severe cardiovascular and cerebrovascular diseases (such as severe cardiac insufficiency, severe sequelae of cerebrovascular disease), or with acute infectious diseases.
- •Have used or using glucocorticoids systemically within 3 months before admission.
- •Have participated in other medical clinical trials within 3 months before admission.
- •Patients with severe liver or kidney function abnormalities
- •Pregnant or lactating women.
- •Patients who lost follow-up.
Outcomes
Primary Outcomes
Healing rate of wound surface
Time Frame: 12 months after surgical operation
Secondary Outcomes
- Ankle-brachial index(12 months after surgical operation)
- Recurrence rate of foot ulcer(12 months after surgical operation)
Investigators
Hailin Xu
Associate Professor
Peking University People's Hospital