Multicentre Study on Diabetic Foot Treatment

NCT05783115 | Unknown

• 1 other identifier: HANQINGLIN
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Keywords

Diabetic Foot; Tibial Transportation; Autologous mesenchymal stem cells Local Infusion

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months after surgery

Secondary Outcomes (5)

• ulcer area

  3 months after surgery

• Wagner grade

  3 months after surgery

• Painless walking distance

  3 months after surgery

• Ankle brachial index

  3 months after surgery

• skin temperature

  day after surgery

Study Arms (2)

Tibial Transportation

ACTIVE COMPARATOR

Tibial Transportation

Procedure: Tibial Transportation

Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion

EXPERIMENTAL

Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion

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

Interventions

Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion PROCEDURE

transverse bone transport with bone marrow cell transplantation

Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion

Tibial Transportation PROCEDURE

transverse bone transport

Tibial Transportation

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead
• Second Affiliated Hospital of Nantong University: collaborator

Study Sites (1)

Affiliated hospital of nantong university

Nantong, Jiangsu, 226001, China

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Qinglin Han, Dr

  Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinglin Han, Dr

CONTACT

+8651385052222; qlhan2013@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 24, 2023
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: July 1, 2024
• Last Updated: March 24, 2023

Record last verified: 2022-11

Locations

CN (1)