Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04709887
Other study ID # mTTTDFU01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT06154915 - Immune Cells in Diabetic Chronic Foot Ulcers
Completed NCT04624516 - Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence N/A
Not yet recruiting NCT06278935 - Lifestyle Tailored Offloading for Diabetic Foot Ulcers N/A
Completed NCT02373592 - Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer N/A
Active, not recruiting NCT01903044 - Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating Phase 1/Phase 2
Completed NCT02092870 - Adipose Derived Regenerative Cellular Therapy of Chronic Wounds Phase 2
Completed NCT01212120 - The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections N/A
Completed NCT00402727 - Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection Phase 3
Recruiting NCT04085705 - The Prevalence of Contact Allergies for Wound Dressings In Patients With Diabetic Foot Ulcers (PAID Study)
Completed NCT04054804 - Digital Foot Check by Using the D-Foot, a New Software
Not yet recruiting NCT04537676 - Patient Empowerment Study
Completed NCT04480801 - The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer N/A
Recruiting NCT04564443 - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot N/A
Recruiting NCT05974592 - The Effect of Nurse-Led Diabetic Foot Self-Management Training Program N/A
Not yet recruiting NCT04630795 - ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.
Not yet recruiting NCT05431660 - Diabetic Foot School and Biomechanics N/A
Completed NCT05101473 - Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study N/A
Completed NCT05123157 - Pattern and Type of Amputation and Mortality Rate Associated With Diabetic Foot in Jeddah, Saudi Arabia: A Retrospective Cohort Study
Enrolling by invitation NCT05043636 - Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4
Completed NCT03254095 - Predictors of Skin Temperature, Plantar Pressure and Ulceration in Diabetic Foot Patients.