Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot

January 14, 2021 updated by: Hailin Xu, Peking University People's Hospital
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

332

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yusong Yuan, Master
  • Phone Number: +86 18801229862
  • Email: xiaxi@pku.edu.cn

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Hailin Xu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Rate of popliteal artery stenosis < 50%, W.
If the rate of popliteal artery stenosis of patients < 50%, the patients only receive the wound treatment.
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.
OTHER: Rate of popliteal artery stenosis < 50%, WT.
If the rate of popliteal artery stenosis of patients < 50%, the patients receive the wound treatment and tibial transverse transport surgery.
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.
Procedure: 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.
OTHER: Rate of popliteal artery stenosis ≥ 50%, WV.
If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment and vascular intervention surgery.
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.
Procedure: 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.
OTHER: Rate of popliteal artery stenosis ≥ 50%, WT.
If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment and tibial transverse transport surgery.
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.
Procedure: 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.
OTHER: Rate of popliteal artery stenosis ≥ 50%, WVT.
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
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.
Procedure: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Healing rate of wound surface
Time Frame: 12 months after surgical operation
12 months after surgical operation

Secondary Outcome Measures

Outcome Measure
Time Frame
Ankle-brachial index
Time Frame: 3 months after surgical operation
3 months after surgical operation
Ankle-brachial index
Time Frame: 12 months after surgical operation
12 months after surgical operation
Recurrence rate of foot ulcer
Time Frame: 12 months after surgical operation
12 months after surgical operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Study Director: Hailin Xu, MD, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ANTICIPATED)

January 1, 2022

Study Completion (ANTICIPATED)

January 1, 2024

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (ACTUAL)

January 14, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mTTTDFU01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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