Multicentre Study on Diabetic Foot Treatment (MSDFT)

Affiliated Hospital of Nantong University

Status: Enrolling

Conditions: Diabetic Foot

Treatments: Procedure: Tibial Transportation; Procedure: Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05783115

HANQINGLIN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Tibial Transportation

Active Comparator group

Description:

Tibial Transportation

Treatment:

Procedure: Tibial Transportation

Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion

Experimental group

Description:

Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion

Treatment:

Procedure: Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion