Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot

Diabetic Foot Clinical Trial

Official title:

Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04709887
• Other study ID #: mTTTDFU01
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: January 1, 2024

Study information

• Verified date: January 2021
• Source: Peking University People's Hospital
• Contact: Yusong Yuan, Master
• Phone: +86 18801229862
• Email: xiaxi[@]pku.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 332
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Ischemia
• Ischemic Diabetic Foot Ulcer
• Popliteal Artery Stenosis

Intervention

Procedure:
• Wound treatment
According to the guidelines and recommendations of the International Diabetic Foot Working Group, ulcer surface debridement, negative pressure suction drainage, and routine dressing were performed until the wound healed or the end of the trial.
• Vascular intervention surgery
Segmented distal angiography under the guidance of digital subtraction angiography (DSA) were perform after local anesthesia. The superficial artery is expanded by a 3-4 mm balloon.
• Tibial transverse transport surgery
In the anteromedial area of the proximal tibia of the affected limb, the external fixation frame was compared with the area along the midline of the medial longitudinal axis of the proximal tibia. Subsequently, two 3.0 Steinmann pins were inserted through the single layer of cortical bone. The skin was cut along the long axis with the 3.0 Steinmann pin as the centre, and the subcutaneous tissue was separate bluntly to expose the periosteum. The Steinmann pins were used as the centre point for the drilling on four sides with a 2.0 drill bit and use of a rapid osteotomy device; the length of each side was 2.5 cm. Subperiosteal osteotomy was performed with a 5-mm narrow bone knife at an angle of 15°-30° to the bone surface. The surgeons should pay attention to protect the blood supply of the periosteum during this procedure. The external fixators were fixed with 4.0 Steinmann pins at the distal and proximal ends. The subcutaneous tissue and skin were sutured.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing rate of wound surface		12 months after surgical operation
Secondary	Ankle-brachial index		3 months after surgical operation
Secondary	Ankle-brachial index		12 months after surgical operation
Secondary	Recurrence rate of foot ulcer		12 months after surgical operation