Diabetic FootPhase 1/2NCT06480123
Stem Cell Derived Exome for Treatment of Diabetic Foot
A Phase 1/2 study testing Skin drug prepared with exome originated from stem cell in people with Diabetic Foot and Stem Cell, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This trial is designed to investigate the safety and efficacy of patients with diabetic foot by using stem cell derived exome. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Foot, Stem Cell
- What is being tested?
- Skin drug prepared with exome originated from stem cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 30 Dec 2033
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of diabetic foot.
- Signed informed consent before recruiting.
- Age above 18 years or less than 90 years.
- ECOG score < 4
- Tolerable coagulation function or reversible coagulation disorders
- Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9/L; Hb≥90g/L； PLT ≥50×10E9/L；INR < 2.3 or PT < 6 seconds above control；Cr ≤ 145.5 umul/L；Albumin > 28 g/L；Total bilirubin < 51 μmol/L
- Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
Who cannot join
- Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
- Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
- Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
- Patients have poor compliance.
- Allergic to the skin drug;
- Any agents which could affect the absorption or pharmacokinetics of the study drugs
- Other conditions that investigator decides not suitable for the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
About this study
Official title: Skin Drug Prepared From Stem Cell Derived Exome for Treatment of Diabetic Foot: a Phase II Clinical Trial
This trial is designed to investigate the safety and efficacy of patients with diabetic foot by using stem cell derived exome.
Read the detailed description
It is estimated that about 150 million people are suffering diabetes mellitus, of whom more than 15% will develop foot ulcers or gangrene at some times, so called diabetic foot. The diabetic foot is very difficult to cure by traditional approaches.
This phase I clinical trial is designed to assess the safety and theraputical benefit of the stem cell derived exome.
- Conditions
- Diabetic Foot, Stem Cell
- Being tested
- Skin drug prepared with exome originated from stem cell
- Keywords
- Diabetic foot, Stem cell, Exome, Skin drug
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin drug prepared with exome originated from stem cellDrug
Skin drug prepared with exome originated from stem cell will be applied to patient with diabetic foot.
| Study group | Role | What they receive |
|---|---|---|
| Stem Cell Derived Exome | Experimental | Not described Receives: Drug: Skin drug prepared with exome originated from stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the treatment
Safety will be assessed by recording all types of advise effects upon and after the treatment.
Measured: Six months
Efficacy of the treatment
Efficacy will be defined as objective response rate + steady disease rate.
Measured: Six months
Secondary outcomes (1)
Duration of remission (DOR)
DOR will be defined as the duration of the diabetic foot remission.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Aug 2024 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2033 (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 Second Affiliated Hospital of Guangzhou Medical 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenfeng Zhang, MD, PhD, Principal investigator, Second Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480123
- Sponsor's protocol ID
- ZZ-SC-EXOME-DF 026
- Status last verified
- Jun 2024
- First submitted
- 23 Jun 2024
- Last updated
- 28 Jun 2024
- 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 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Drug Prepared From Stem Cell Derived Exome for Treatment of Diabetic Foot: a Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06480123
- Acronym / sponsor ID
- ZZ-SC-EXOME-DF 026
- Conditions
- Diabetic Foot, Stem Cell
- Keywords
- Diabetic foot, Stem cell, Exome, Skin drug
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2033 (estimated)
- First posted
- 28 Jun 2024 (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.
This trial is designed to investigate the safety and efficacy of patients with diabetic foot by using stem cell derived exome.
Detailed description
It is estimated that about 150 million people are suffering diabetes mellitus, of whom more than 15% will develop foot ulcers or gangrene at some times, so called diabetic foot. The diabetic foot is very difficult to cure by traditional approaches.
This phase I clinical trial is designed to assess the safety and theraputical benefit of the stem cell derived exome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem Cell Derived Exome | Experimental | Drug: Skin drug prepared with exome originated from stem cell |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of diabetic foot.
- Signed informed consent before recruiting.
- Age above 18 years or less than 90 years.
- ECOG score < 4
- Tolerable coagulation function or reversible coagulation disorders
Key exclusion criteria (7 listed)
- Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
- Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
- Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
- Patients have poor compliance.
- Allergic to the skin drug;
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 |
|---|---|---|
| Skin drug prepared with exome originated from stem cellSkin drug prepared with exome originated from stem cell will be applied to patient with diabetic foot. | Drug | Stem Cell Derived Exome |
Primary outcome
Safety of the treatment
Time frame: Six months
Safety will be assessed by recording all types of advise effects upon and after the treatment.
Efficacy of the treatment
Time frame: Six months
Efficacy will be defined as objective response rate + steady disease rate.
1 secondary outcome
Duration of remission (DOR)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
Related trials for Diabetic Foot
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.
Zhenfeng Zhang, MD, PhD principal investigator
Second Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Skin drug prepared with exome originated from stem cell in people with Diabetic Foot and Stem Cell, run by Second Affiliated Hospital of Guangzhou Medical 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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 28 Jun 2024. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenfeng Zhang, MD, PhD (+862039195966, zhangzhf@gzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the treatment (time frame: Six 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 28 Jun 2024.