Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot

Not Applicable

• Conditions: Ischemic Diabetic Foot Ulcer; Popliteal Artery Stenosis; Diabetic Foot
• Interventions: Procedure: Wound treatment; Procedure: Tibial transverse transport surgery; Procedure: Vascular intervention surgery

• Registration Number: NCT04709887
• Lead Sponsor: Peking University People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Status Verified: 2021-01
• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-19
• Primary Completion: 2022-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 332

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rate of popliteal artery stenosis < 50%, W.	Wound treatment	If the rate of popliteal artery stenosis of patients \< 50%, the patients only receive the wound treatment.
Rate of popliteal artery stenosis < 50%, WT.	Tibial transverse transport surgery	If the rate of popliteal artery stenosis of patients \< 50%, the patients receive the wound treatment and tibial transverse transport surgery.
Rate of popliteal artery stenosis ≥ 50%, WV.	Wound treatment	If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment and vascular intervention surgery.
Rate of popliteal artery stenosis ≥ 50%, WT.	Wound treatment	If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment and tibial transverse transport surgery.
Rate of popliteal artery stenosis ≥ 50%, WVT.	Vascular intervention surgery	If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment, vascular intervention and tibial transverse transport surgery.
Rate of popliteal artery stenosis < 50%, WT.	Wound treatment	If the rate of popliteal artery stenosis of patients \< 50%, the patients receive the wound treatment and tibial transverse transport surgery.
Rate of popliteal artery stenosis ≥ 50%, WV.	Vascular intervention surgery	If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment and vascular intervention surgery.
Rate of popliteal artery stenosis ≥ 50%, WVT.	Wound treatment	If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment, vascular intervention and tibial transverse transport surgery.
Rate of popliteal artery stenosis ≥ 50%, WT.	Tibial transverse transport surgery	If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment and tibial transverse transport surgery.
Rate of popliteal artery stenosis ≥ 50%, WVT.	Tibial transverse transport surgery	If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment, vascular intervention and tibial transverse transport surgery.

Primary Outcome Measures

Name	Time	Method
Healing rate of wound surface	12 months after surgical operation

Secondary Outcome Measures

Name	Time	Method
Ankle-brachial index	12 months after surgical operation
Recurrence rate of foot ulcer	12 months after surgical operation

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China