Diabetic FootMSDFTNCT05783115
Multicentre Study on Diabetic Foot Treatment
A study testing Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion and Tibial Transportation in people with Diabetic Foot, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion and Tibial Transportation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated hospital of nantong university
Nantong, Jiangsu, 226001
Qinglin Han, Dr., 86-513-85052222, qlhan2013@163.com
About this study
Official title: Multicentre Study on Diabetic Foot Treatment by Tibial Transportation Combined With Autologous Mesenchymal Stem Cells Local Infusion
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.
Read the 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.
- Conditions
- Diabetic Foot
- Being tested
- Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion, Tibial Transportation
- Keywords
- Diabetic Foot, Tibial Transportation, Autologous mesenchymal stem cells Local Infusion
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibial Transportation Combined With Autologous mesenchymal stem cells Local InfusionProcedure or surgery
transverse bone transport with bone marrow cell transplantation
Tibial TransportationProcedure or surgery
transverse bone transport
| Study group | Role | What they receive |
|---|---|---|
| Tibial Transportation | Active comparator | Tibial Transportation Receives: Procedure: Tibial Transportation |
| Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion | Experimental | Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion Receives: Procedure: Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after surgery
Secondary outcomes (5)
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.
Measured: 3 months after surgery
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.
Measured: 3 months after surgery
Painless walking distance
Painless walking distance
Measured: 3 months after surgery
Ankle brachial index
a simple test that compares the blood pressure in the upper and lower limbs
Measured: 3 months after surgery
skin temperature
skin temperature
Measured: day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Nantong University
- Responsible party
- Sponsor
- Investigators
- Qinglin Han, Dr, Principal investigator, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783115
- Sponsor's protocol ID
- HANQINGLIN
- Acronym
- MSDFT
- Status last verified
- Nov 2022
- First submitted
- 6 Mar 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Study on Diabetic Foot Treatment by Tibial Transportation Combined With Autologous Mesenchymal Stem Cells Local Infusion
- ClinicalTrials.gov ID
- NCT05783115
- Acronym / sponsor ID
- MSDFT / HANQINGLIN
- Conditions
- Diabetic Foot
- Keywords
- Diabetic Foot, Tibial Transportation, Autologous mesenchymal stem cells Local Infusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Nantong University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tibial Transportation | Active comparator | Procedure: Tibial TransportationTibial Transportation |
| Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion | Experimental | Procedure: Tibial Transportation Combined With Autologous mesenchymal stem cells Local InfusionTibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusiontransverse bone transport with bone marrow cell transplantation | Procedure or surgery | Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion |
| Tibial Transportationtransverse bone transport | Procedure or surgery | Tibial Transportation |
Primary outcome
visual analogue scale
Time frame: 3 months after surgery
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.
5 secondary outcomes
ulcer area
Time frame: 3 months after surgery
Wagner grade
Time frame: 3 months after surgery
Painless walking distance
Time frame: 3 months after surgery
Ankle brachial index
Time frame: 3 months after surgery
skin temperature
Time frame: day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qinglin Han, Dr principal investigator
Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tibial Transportation Combined With Autologous mesenchymal stem cells Local Infusion and Tibial Transportation in people with Diabetic Foot, run by Affiliated Hospital of Nantong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qinglin Han, Dr (+8651385052222, qlhan2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.