Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot

Peking University

Status: Unknown

Conditions: Popliteal Artery Stenosis; Diabetic Foot; Ischemic Diabetic Foot Ulcer

Treatments: Procedure: Vascular intervention surgery; Procedure: Tibial transverse transport surgery; Procedure: Wound treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04709887

mTTTDFU01

Details and patient eligibility

About

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.

Enrollment: 332 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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332 participants in 5 patient groups

Rate of popliteal artery stenosis < 50%, W.

Other group

Description:

If the rate of popliteal artery stenosis of patients \< 50%, the patients only receive the wound treatment.

Treatment:

Procedure: Wound treatment

Rate of popliteal artery stenosis < 50%, WT.

Other group

Description:

If the rate of popliteal artery stenosis of patients \< 50%, the patients receive the wound treatment and tibial transverse transport surgery.

Treatment:

Procedure: Wound treatment

Procedure: Tibial transverse transport surgery

Rate of popliteal artery stenosis ≥ 50%, WV.

Other group

Description:

If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment and vascular intervention surgery.

Treatment:

Procedure: Vascular intervention surgery

Procedure: Wound treatment

Rate of popliteal artery stenosis ≥ 50%, WT.

Other group

Description:

If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment and tibial transverse transport surgery.

Treatment:

Procedure: Wound treatment

Procedure: Tibial transverse transport surgery

Rate of popliteal artery stenosis ≥ 50%, WVT.

Other group

Description:

If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment, vascular intervention and tibial transverse transport surgery.

Treatment:

Procedure: Vascular intervention surgery

Procedure: Wound treatment

Procedure: Tibial transverse transport surgery