Multicentre Study on Diabetic Foot Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetic Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tibial Transportation

Group Type ACTIVE_COMPARATOR

Tibial Transportation

Intervention Type PROCEDURE

transverse bone transport

Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion

Group Type EXPERIMENTAL

Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion

Intervention Type PROCEDURE

transverse bone transport with bone marrow cell transplantation

Interventions

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Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion

transverse bone transport with bone marrow cell transplantation

Intervention Type PROCEDURE

Tibial Transportation

transverse bone transport

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No