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Multicentre Study on Diabetic Foot Treatment (MSDFT)

Primary Purpose

Diabetic Foot

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion
Tibial Transportation
Sponsored by
Affiliated Hospital of Nantong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring Diabetic Foot, Tibial Transportation, Autologous mesenchymal stem cells Local Infusion

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Affiliated hospital of nantong universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Tibial Transportation

Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion

Arm Description

Tibial Transportation

Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion

Outcomes

Primary Outcome Measures

visual analogue scale
Visual analog scale (VAS) and its corresponding visual analog pain scale, is a psychometric scale that is generally used in hospitals and clinics by doctors to conduct pain scale surveys to understand varying degrees of pain or discomfort experienced by a patient.VAS ranges from 0 to 10 and a higher score means worse outcome.

Secondary Outcome Measures

ulcer area
ulcer area will be record in cm2. Use a digital camera to photograph each chronic skin ulcer wound at a fixed height and angle, and use a ruler as a marker. Each photo was measured 3 times using NIH ImageJ software and analyzed using a ruler as a scale. Import the pictures collected by the digital camera into the computer, select the clearest picture, apply the NIH ImageJ software, use a tracer pen to sketch the contour of the ulcer surface along the edge of the ulcer, and obtain the pixel square value. At the same time, use a tracer pen to sketch the linear distance of 1 cm on the scale, to obtain the pixel value of 1 cm linear distance, and then multiply the pixel value of 1 cm to obtain. The pixel square value of 1 cm2 is divided by the pixel square value of the ulcer surface contour to obtain the chronic ulcer skin area.
Wagner grade
The Wagner Diabetic Foot Ulcer Grade Classification System. The Wagner diabetic foot ulcer classification system assesses ulcer depth and the presence of osteomyelitis or gangrene by using the following grades.Wagner grade ranges from 0 to 10 and a higher score means worse outcome.
Painless walking distance
Painless walking distance
Ankle brachial index
a simple test that compares the blood pressure in the upper and lower limbs
skin temperature
skin temperature

Full Information

First Posted
March 6, 2023
Last Updated
March 22, 2023
Sponsor
Affiliated Hospital of Nantong University
Collaborators
Second Affiliated Hospital of Nantong University
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1. Study Identification

Unique Protocol Identification Number
NCT05783115
Brief Title
Multicentre Study on Diabetic Foot Treatment
Acronym
MSDFT
Official Title
Multicentre Study on Diabetic Foot Treatment by Tibial Transportation Combined With Autologous Mesenchymal Stem Cells Local Infusion
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital of Nantong University
Collaborators
Second Affiliated Hospital of Nantong University

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot
Keywords
Diabetic Foot, Tibial Transportation, Autologous mesenchymal stem cells Local Infusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tibial Transportation
Arm Type
Active Comparator
Arm Description
Tibial Transportation
Arm Title
Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion
Arm Type
Experimental
Arm Description
Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion
Intervention Type
Procedure
Intervention Name(s)
Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion
Intervention Description
transverse bone transport with bone marrow cell transplantation
Intervention Type
Procedure
Intervention Name(s)
Tibial Transportation
Intervention Description
transverse bone transport
Primary Outcome Measure Information:
Title
visual analogue scale
Description
Visual analog scale (VAS) and its corresponding visual analog pain scale, is a psychometric scale that is generally used in hospitals and clinics by doctors to conduct pain scale surveys to understand varying degrees of pain or discomfort experienced by a patient.VAS ranges from 0 to 10 and a higher score means worse outcome.
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
ulcer area
Description
ulcer area will be record in cm2. Use a digital camera to photograph each chronic skin ulcer wound at a fixed height and angle, and use a ruler as a marker. Each photo was measured 3 times using NIH ImageJ software and analyzed using a ruler as a scale. Import the pictures collected by the digital camera into the computer, select the clearest picture, apply the NIH ImageJ software, use a tracer pen to sketch the contour of the ulcer surface along the edge of the ulcer, and obtain the pixel square value. At the same time, use a tracer pen to sketch the linear distance of 1 cm on the scale, to obtain the pixel value of 1 cm linear distance, and then multiply the pixel value of 1 cm to obtain. The pixel square value of 1 cm2 is divided by the pixel square value of the ulcer surface contour to obtain the chronic ulcer skin area.
Time Frame
3 months after surgery
Title
Wagner grade
Description
The Wagner Diabetic Foot Ulcer Grade Classification System. The Wagner diabetic foot ulcer classification system assesses ulcer depth and the presence of osteomyelitis or gangrene by using the following grades.Wagner grade ranges from 0 to 10 and a higher score means worse outcome.
Time Frame
3 months after surgery
Title
Painless walking distance
Description
Painless walking distance
Time Frame
3 months after surgery
Title
Ankle brachial index
Description
a simple test that compares the blood pressure in the upper and lower limbs
Time Frame
3 months after surgery
Title
skin temperature
Description
skin temperature
Time Frame
day after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qinglin Han, Dr
Phone
+8651385052222
Email
qlhan2013@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qinglin Han, Dr
Organizational Affiliation
Affiliated Hospital of Nantong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated hospital of nantong university
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinglin Han, Dr.
Phone
86-513-85052222
Email
qlhan2013@163.com

12. IPD Sharing Statement

Learn more about this trial

Multicentre Study on Diabetic Foot Treatment

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