Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot

NCT04709887 | Unknown

• 1 other identifier: mTTTDFU01
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Ischemic Diabetic Foot Ulcer; Popliteal Artery Stenosis

Keywords

Ischemic Diabetic Foot Ulcer; Surgical Strategy; Cohort study

Outcome Measures

Primary Outcomes (1)

• Healing rate of wound surface

  12 months after surgical operation

Secondary Outcomes (3)

• Ankle-brachial index

  3 months after surgical operation

• Ankle-brachial index

  12 months after surgical operation

• Recurrence rate of foot ulcer

  12 months after surgical operation

Study Arms (5)

Rate of popliteal artery stenosis < 50%, W.

OTHER

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

Procedure: Wound treatment

Rate of popliteal artery stenosis < 50%, WT.

OTHER

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

Procedure: Wound treatment; Procedure: Tibial transverse transport surgery

Rate of popliteal artery stenosis ≥ 50%, WV.

OTHER

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

Procedure: Wound treatment; Procedure: Vascular intervention surgery

Rate of popliteal artery stenosis ≥ 50%, WT.

OTHER

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

Procedure: Wound treatment; Procedure: Tibial transverse transport surgery

Rate of popliteal artery stenosis ≥ 50%, WVT.

OTHER

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

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

Interventions

Wound treatment PROCEDURE

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.

Rate of popliteal artery stenosis < 50%, W.; Rate of popliteal artery stenosis < 50%, WT.; Rate of popliteal artery stenosis ≥ 50%, WT.; Rate of popliteal artery stenosis ≥ 50%, WV.; Rate of popliteal artery stenosis ≥ 50%, WVT.

Vascular intervention surgery PROCEDURE

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.

Rate of popliteal artery stenosis ≥ 50%, WV.; Rate of popliteal artery stenosis ≥ 50%, WVT.

Tibial transverse transport surgery PROCEDURE

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.

Rate of popliteal artery stenosis < 50%, WT.; Rate of popliteal artery stenosis ≥ 50%, WT.; Rate of popliteal artery stenosis ≥ 50%, WVT.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Hailin Xu, MD

  Peking University People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Yusong Yuan, Master

CONTACT

+86 18801229862; xiaxi@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: January 1, 2017
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2024
• Last Updated: January 19, 2021

Record last verified: 2021-01

Locations

CN (1)