Clinical trial NCT05783115: Multicentre Study on Diabetic Foot Treatment
Official title: Multicentre Study on Diabetic Foot Treatment by Tibial Transportation Combined With Autologous Mesenchymal Stem Cells Local Infusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot
Keywords: Diabetic Foot
Tibial Transportation
Autologous mesenchymal stem cells Local Infusion
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Nantong University
First posted: 2023-03-24
Enrollment: 46
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With a rapidly growing incidence rate and a high disability rate,The Diabetic Foot has long been difficult to treatment, which has caused a huge burden to patients and society. The blood supply disorder is one of the main reasons that lead to the morbidity and difficulty in healing of diabetes feet, but there is still a lack of particularly effective treatment to improve the blood supply of diabetes feet. Both transverse bone transport and bone marrow cell transplantation have shown some clinical effects. However, the difference in efficacy between the two has not been reported. In this study, investigators compared the therapeutic effects of these two methods on the healing of diabetes foot ulcers through a controlled clinical study.

Detailed description: In this study, investigators compared the therapeutic effects of Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion on the healing of diabetes foot ulcers through a controlled clinical study.

Eligibility criteria: Inclusion Criteria:

* Symptoms: Wagner stage 2 or above foot ulcer (deep ulcer, abscess or osteomyelitis; localized gangrene, characterized by ischemic gangrene, usually with neuropathy; gangrene of the whole foot), may be accompanied by chronic limb pain, intermittent claudication, cold sensation, abnormal skin sensation and other symptoms
* Have not taken reserpine in the past week or can change to other antihypertensive drugs
* Voluntary participation and signing of informed consent

Exclusion Criteria:

* Patients with organ failure diagnosed by doctors in the past: such as heart failure, liver and kidney failure
* Patients with myocardial infarction diagnosed by doctors in the past
* With congenital or acquired organic heart disease
* With basic disease is in the active stage, such as newly diagnosed leukemia patients, or leukemia patients with relapse and refractory
* Active infection: pulmonary infection, intestinal infection and other existing infections
* Severe anemia
* Severe osteoporosis
* Have undergone amputation of both lower limbs
* The investigator judged that it was not suitable to participate in this study, including the existence of abnormal laboratory test results or clinical abnormal symptoms/signs
* There are any of the following conditions that may limit the patient's compliance or hinder data collection: dementia; Serious mental disorder, unable to express will; Unable to complete the research evaluation as required
* Other contraindications of anesthesia or surgery

Primary outcomes:
measure: visual analogue scale
timeFrame: 3 months after surgery
Secondary outcomes:
measure: ulcer area
timeFrame: 3 months after surgery
measure: Wagner grade
timeFrame: 3 months after surgery
measure: Painless walking distance
timeFrame: 3 months after surgery
measure: Ankle brachial index
timeFrame: 3 months after surgery
measure: skin temperature
timeFrame: day after surgery
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated hospital of nantong university
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Qinglin Han, Dr
role: PRINCIPAL_INVESTIGATOR
References: