Diabetic Foot UlcerPhase 3DFU-MNCNCT04689425
Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer
A Phase 3 study testing Umbilical cord blood mononuclear cell gel（MNC） and The platelet rich plasma（PRP） in people with Diabetic Foot Ulcer, run by Peking University Third Hospital at 1 site in China.
Trial summary
Umbilical cord blood mononuclear cells (MNC) may improve the wound repair ability. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP and MNC with PRP alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Umbilical cord blood mononuclear cell gel（MNC） and The platelet rich plasma（PRP）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2021to 31 Dec 2024
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age of the patients is 18-80 years old;
- Diabetic foot is diagnosed and Wagner grade is above Ⅱ;
- The duration of ulcer is 2 months or more, with no healing trend for 2 weeks or more.
- Fasting blood glucose ≤ 9mmol / L, 2 hours postprandial blood glucose ≤ 13mmol / L;
- The skin oxygen partial pressure around the wound is more than 20mmHg;
- Sign written informed consent.
Who cannot join
- Acute spreading infection of the wound, e.g. massive exudation, redness, swelling, heat, pain.
- Acute myocardial infarction, heart failure, hepatitis;
- Active bleeding or hematoma in the wound;
- Serum albumin <25g/L;
- Hemoglobin <80g/L;
- Platelets <50×109/L;
- Poor cooperate or compliance;The patient cannot cooperate or is.
- Mentally disabled.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
long zhang, Dr., 13041210677, longzh2000@163.com
About this study
Official title: The Efficacy and Safety of Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer.
Umbilical cord blood mononuclear cells (MNC) may improve the wound repair ability. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP and MNC with PRP alone.
Read the detailed description
The difficulty in the healing of diabetic foot is related to the loss of local repair microenvironment. The platelet rich plasma (PRP) can improve the repair ability, however, the requirement for wound bed preparation is strict, or treatment failure may occur. Umbilical cord blood mononuclear cells (MNC) may provide a better repair environment through paracrine action. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP and MNC with PRP alone.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Umbilical cord blood mononuclear cell gel（MNC）, The platelet rich plasma（PRP）
- Keywords
- Diabetic Foot Ulcer, Umbilical cord blood mononuclear cells
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord blood mononuclear cell gel（MNC）Drug
Also called MNC+PRP
Local wound treatment by combination of PRP and MNC, once;
The platelet rich plasma（PRP）Drug
Also called PRP
Local wound treatment by PRP alone, once.
| Study group | Role | What they receive |
|---|---|---|
| MNC+PRP | Experimental | The combination of PRP and MNC Receives: Drug: Umbilical cord blood mononuclear cell gel（MNC）; Drug: The platelet rich plasma（PRP） |
| PRP | Active comparator | PRP alone. Receives: Drug: The platelet rich plasma（PRP） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound area reduction rate
The ratio of the reduced area after one week of treatment to the original area
Measured: one week
Secondary outcomes (2)
Wound healing rate at 4 weeks
Percentage of patients with healed wound at 4 weeks
Measured: 4 weeks
Amputation rate at 8 weeks
Percentage of patients with major amputation at 8 weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start30 Mar 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Long Zhang, Peking University Third Hospital
- Investigators
- Long Zhang, Dr., Principal investigator, Peking University Third Hospital Wound Healing Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689425
- Sponsor's protocol ID
- Long2020-DFU-MNC
- Acronym
- DFU-MNC
- Status last verified
- Sep 2022
- First submitted
- 24 Dec 2020
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer.
- ClinicalTrials.gov ID
- NCT04689425
- Acronym / sponsor ID
- DFU-MNC / Long2020-DFU-MNC
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic Foot Ulcer, Umbilical cord blood mononuclear cells
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Dec 2020 (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.
Umbilical cord blood mononuclear cells (MNC) may improve the wound repair ability. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP and MNC with PRP alone.
Detailed description
The difficulty in the healing of diabetic foot is related to the loss of local repair microenvironment. The platelet rich plasma (PRP) can improve the repair ability, however, the requirement for wound bed preparation is strict, or treatment failure may occur. Umbilical cord blood mononuclear cells (MNC) may provide a better repair environment through paracrine action. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP and MNC with PRP alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MNC+PRP | Experimental | Drug: Umbilical cord blood mononuclear cell gel（MNC）, Drug: The platelet rich plasma（PRP）The combination of PRP and MNC |
| PRP | Active comparator | Drug: The platelet rich plasma（PRP）PRP alone. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The age of the patients is 18-80 years old;
- Diabetic foot is diagnosed and Wagner grade is above Ⅱ;
- The duration of ulcer is 2 months or more, with no healing trend for 2 weeks or more.
- Fasting blood glucose ≤ 9mmol / L, 2 hours postprandial blood glucose ≤ 13mmol / L;
- The skin oxygen partial pressure around the wound is more than 20mmHg;
Key exclusion criteria (8 listed)
- Acute spreading infection of the wound, e.g. massive exudation, redness, swelling, heat, pain.
- Acute myocardial infarction, heart failure, hepatitis;
- Active bleeding or hematoma in the wound;
- Serum albumin <25g/L;
- Hemoglobin <80g/L;
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 |
|---|---|---|
| Umbilical cord blood mononuclear cell gel（MNC）Also: MNC+PRPLocal wound treatment by combination of PRP and MNC, once; | Drug | MNC+PRP |
| The platelet rich plasma（PRP）Also: PRPLocal wound treatment by PRP alone, once. | Drug | MNC+PRP, PRP |
Primary outcome
Wound area reduction rate
Time frame: one week
The ratio of the reduced area after one week of treatment to the original area
2 secondary outcomes
Wound healing rate at 4 weeks
Time frame: 4 weeks
Amputation rate at 8 weeks
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Long Zhang, Dr. principal investigator
Peking University Third Hospital Wound Healing Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Umbilical cord blood mononuclear cell gel（MNC） and The platelet rich plasma（PRP） in people with Diabetic Foot Ulcer, run by Peking University Third Hospital 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 6 inclusion and 8 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 29 Sep 2022. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Long Zhang, Dr. (+8613041210677, longzh2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound area reduction rate (time frame: one week). 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 29 Sep 2022.