Diabetic Foot UlcerEarly Phase 1NCT03248466
PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer
A Early Phase 1 study testing PRG combined with BMMSCs transplantation in people with Diabetic Foot Ulcer, run by Third Military Medical University at 2 sites in China.
Trial summary
To investigate the treatment effect between Traditional treatment and transplantation of autologous PRG combined with autologous BMMSCs for treatment of diabetic foot ulcer. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- PRG combined with BMMSCs transplantation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 30 Aug 2017to 1 Jul 2020
- Phase
- Early Phase 1
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic foot according to The Wagner is 2-3 graded;
Who cannot join
- Type 1 diabetes mellitus,presence of autoimmune diabetes;
- Gestational diabetes;
- Patients with heart, liver, or renal function impairment;presence of severe infections or cerebrovascular disease.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Southwest Hospital of the Third Military Medical University
Chongqing, Chongqing Municipality, +86
wu qinan, doctor, 13452867542, wqn11@126.com
- Recruiting
Endocrine Department, the First Affiliated Hospital of the Third Military Medical University
Chongqing, Chongqing Municipality, 400038
qinan wu, master, 02368765217 ext. 86, wqn11@126.com
qinan wu, master
About this study
Official title: Transplantation of Autologous Platelet Rich Gel Combined With Autologous Bone Marrow Mesenchymal Stem Cells for Treatment of Diabetic Foot Ulcer
To investigate the treatment effect between Traditional treatment and transplantation of autologous PRG combined with autologous BMMSCs for treatment of diabetic foot ulcer.
Read the detailed description
60 diabetic foot ulcer in our hospital will divide into 3 groups: group A (20 diabetic foot ulcer who give Traditional treatment), group B (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel)，group C (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel combined with autologous bone marrow mesenchymal stem cells). The age, height, weight, blood glucose, glycosylated hemoglobin A1c（HbA1c）, lipid, blood pressure, course of disease, Wound healing rate,transcutaneous oxygen pressure,Amputation rate,Hospital stay will record respectively. And High-sensitive C-reactive protein (HsCRP) and Tumor necrosis factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, one way Analysis of Variance will be analyzed the significantion among 3 groups.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- PRG combined with BMMSCs transplantation
- Keywords
- platelet rich gel, BMMSCs, diabetic foot ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRG combined with BMMSCs transplantationBiological
Also called PRG
PRG combined with BMMSCs transplantation
| Study group | Role | What they receive |
|---|---|---|
| Traditional treatment | Placebo comparator | Traditional treatment such as insulin,antidiabetes,dressing Receives: Biological: PRG combined with BMMSCs transplantation |
| PRG combined with BMMSCs transplantation | Experimental | Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG combined with BMMSCs Receives: Biological: PRG combined with BMMSCs transplantation |
| PRG treatment | No intervention | Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation rate
Amputation rate up to 6 months
Measured: up to 6 months
hospital stay
hospital stay
Measured: up to 6 months
Secondary outcomes (2)
Wound healing time
Wound healing time
Measured: up to 6 months
Transcutaneous oxygen partial pressure
Transcutaneous oxygen partial pressure
Measured: Transcutaneous oxygen partial pressure up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start30 Aug 2017 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jul 2020 (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.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- diabetic foot ulcer which Wagner classification at 2-3 grade.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Qinan, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248466
- Sponsor's protocol ID
- endocrine department of TMMU
- Status last verified
- Aug 2017
- First submitted
- 9 Aug 2017
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Autologous Platelet Rich Gel Combined With Autologous Bone Marrow Mesenchymal Stem Cells for Treatment of Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT03248466
- Acronym / sponsor ID
- endocrine department of TMMU
- Conditions
- Diabetic Foot Ulcer
- Keywords
- platelet rich gel, BMMSCs, diabetic foot ulcer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 30 Aug 2017 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 14 Aug 2017 (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.
To investigate the treatment effect between Traditional treatment and transplantation of autologous PRG combined with autologous BMMSCs for treatment of diabetic foot ulcer.
Detailed description
60 diabetic foot ulcer in our hospital will divide into 3 groups: group A (20 diabetic foot ulcer who give Traditional treatment), group B (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel)，group C (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel combined with autologous bone marrow mesenchymal stem cells). The age, height, weight, blood glucose, glycosylated hemoglobin A1c（HbA1c）, lipid, blood pressure, course of disease, Wound healing rate,transcutaneous oxygen pressure,Amputation rate,Hospital stay will record respectively. And High-sensitive C-reactive protein (HsCRP) and Tumor necrosis factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, one way Analysis of Variance will be analyzed the significantion among 3 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- diabetic foot ulcer which Wagner classification at 2-3 grade.
| Arm | Type | Receives |
|---|---|---|
| Traditional treatment | Placebo comparator | Biological: PRG combined with BMMSCs transplantationTraditional treatment such as insulin,antidiabetes,dressing |
| PRG combined with BMMSCs transplantation | Experimental | Biological: PRG combined with BMMSCs transplantationTraditional treatment such as insulin,antidiabetes,dressing and Autologous PRG combined with BMMSCs |
| PRG treatment | No intervention | –Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic foot according to The Wagner is 2-3 graded;
Key exclusion criteria (3 listed)
- Type 1 diabetes mellitus,presence of autoimmune diabetes;
- Gestational diabetes;
- Patients with heart, liver, or renal function impairment;presence of severe infections or cerebrovascular disease.
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 |
|---|---|---|
| PRG combined with BMMSCs transplantationAlso: PRGPRG combined with BMMSCs transplantation | Biological | PRG combined with BMMSCs transplantation, Traditional treatment |
Primary outcome
Amputation rate
Time frame: up to 6 months
Amputation rate up to 6 months
hospital stay
Time frame: up to 6 months
hospital stay
2 secondary outcomes
Wound healing time
Time frame: up to 6 months
Transcutaneous oxygen partial pressure
Time frame: Transcutaneous oxygen partial pressure up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Individual participant dataSharing planned: No
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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.
Endocrine Department, the First Affiliated Hospital of the Third Military Medical University
Chongqing, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PRG combined with BMMSCs transplantation in people with Diabetic Foot Ulcer, run by Third Military Medical University at 2 sites 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 1 inclusion and 3 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 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputation rate (time frame: up to 6 months). The study lists 2 primary outcomes in all. 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 14 Aug 2017.