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Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot

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ClinicalTrials.gov Identifier: NCT04709887
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Hailin Xu, 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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ischemic Diabetic Foot Ulcer Popliteal Artery Stenosis Procedure: Wound treatment Procedure: Vascular intervention surgery Procedure: Tibial transverse transport surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 332 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.

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.

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.

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: 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.

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.




Primary Outcome Measures :
  1. Healing rate of wound surface [ Time Frame: 12 months after surgical operation ]

Secondary Outcome Measures :
  1. Ankle-brachial index [ Time Frame: 3 months after surgical operation ]
  2. Ankle-brachial index [ Time Frame: 12 months after surgical operation ]
  3. Recurrence rate of foot ulcer [ Time Frame: 12 months after surgical operation ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04709887


Contacts
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Contact: Yusong Yuan, Master +86 18801229862 xiaxi@pku.edu.cn

Locations
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China
Peking University People's Hospital Recruiting
Beijing, China
Contact: Hailin Xu, MD         
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Study Director: Hailin Xu, MD Peking University People's Hospital
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Responsible Party: Hailin Xu, Associate Professor, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT04709887    
Other Study ID Numbers: mTTTDFU01
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hailin Xu, Peking University People's Hospital:
Ischemic Diabetic Foot Ulcer
Surgical Strategy
Cohort study
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ischemia
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases