Back to resultsAppropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot
Primary Purpose
Diabetic Foot, Ischemic Diabetic Foot Ulcer, Popliteal Artery Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Wound treatment
Vascular intervention surgery
Tibial transverse transport surgery
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot focused on measuring Ischemic Diabetic Foot Ulcer, Surgical Strategy, Cohort study
Eligibility 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.
Sites / Locations
- Peking University People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Other
Other
Other
Other
Other
Arm Label
Rate of popliteal artery stenosis < 50%, W.
Rate of popliteal artery stenosis < 50%, WT.
Rate of popliteal artery stenosis ≥ 50%, WV.
Rate of popliteal artery stenosis ≥ 50%, WT.
Rate of popliteal artery stenosis ≥ 50%, WVT.
Arm Description
If the rate of popliteal artery stenosis of patients < 50%, the patients only receive the wound treatment.
If the rate of popliteal artery stenosis of patients < 50%, the patients receive the wound treatment and tibial transverse transport surgery.
If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment and vascular intervention surgery.
If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment and 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.
Outcomes
Primary Outcome Measures
Healing rate of wound surface
Secondary Outcome Measures
Ankle-brachial index
Ankle-brachial index
Recurrence rate of foot ulcer
Full Information
NCT ID
NCT04709887
First Posted
January 12, 2021
Last Updated
January 14, 2021
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04709887
Brief Title
Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot
Official Title
Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Ischemic Diabetic Foot Ulcer, Popliteal Artery Stenosis
Keywords
Ischemic Diabetic Foot Ulcer, Surgical Strategy, Cohort study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
332 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rate of popliteal artery stenosis < 50%, W.
Arm Type
Other
Arm Description
If the rate of popliteal artery stenosis of patients < 50%, the patients only receive the wound treatment.
Arm Title
Rate of popliteal artery stenosis < 50%, WT.
Arm Type
Other
Arm Description
If the rate of popliteal artery stenosis of patients < 50%, the patients receive the wound treatment and tibial transverse transport surgery.
Arm Title
Rate of popliteal artery stenosis ≥ 50%, WV.
Arm Type
Other
Arm Description
If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment and vascular intervention surgery.
Arm Title
Rate of popliteal artery stenosis ≥ 50%, WT.
Arm Type
Other
Arm Description
If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment and tibial transverse transport surgery.
Arm Title
Rate of popliteal artery stenosis ≥ 50%, WVT.
Arm Type
Other
Arm Description
If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment, vascular intervention and tibial transverse transport surgery.
Intervention Type
Procedure
Intervention Name(s)
Wound treatment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Vascular intervention surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Tibial transverse transport surgery
Intervention Description
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 Measure Information:
Title
Healing rate of wound surface
Time Frame
12 months after surgical operation
Secondary Outcome Measure Information:
Title
Ankle-brachial index
Time Frame
3 months after surgical operation
Title
Ankle-brachial index
Time Frame
12 months after surgical operation
Title
Recurrence rate of foot ulcer
Time Frame
12 months after surgical operation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yusong Yuan, Master
Phone
+86 18801229862
Email
xiaxi@pku.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hailin Xu, MD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hailin Xu, MD
12. IPD Sharing Statement
Learn more about this trial
Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot
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