Diabete MellitusNCT07818252
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
A study testing TAG adjunctive treatment group and Hydrogel adjunctive treatment group in people with Diabete Mellitus, run by Nanfang Hospital, Southern Medical University.
Trial summary
Diabetic foot ulcer (DFU) is a leading cause of hospitalization, disability, and mortality among diabetic patients, imposing a substantial burden on both patients and national healthcare resources. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Diabete Mellitus
- What is being tested?
- TAG adjunctive treatment group and Hydrogel adjunctive treatment group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2026to 31 Dec 2027
- Phase
- Interventional
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent obtained prior to the first study assessment;
- Male or female patients aged >= 20 and < 80 years;
- Diagnosed with diabetes mellitus (type 1 or type 2) with HbA1c < 12.0% detected during the screening period or within three months prior to randomization;
- Ankle-Brachial Index (ABI) of the target limb >= 0.8 measured during screening or within three months prior to randomization;
- The target ulcer must meet all of the following criteria: a. Wagner Ulcer Grading System grade 1 to 3; b. Located at or below the ankle; c. No infection or mild infection (as defined by IWGDF/IDSA criteria); d. Cross-sectional area after debridement between 1 and 25 cm²; e. Present for at least 4 weeks prior to randomization;
- For women of childbearing potential, negative pregnancy test and not currently breastfeeding at the screening visit;
- Willing and able to attend scheduled visits and comply with study procedures;
Who cannot join
- Presence of gangrene, suppuration, or sinus tract that cannot be removed by debridement;
- Diagnosis of acute Charcot neuroarthropathy based on clinical and/or radiographic examination;
- Undergone revascularization procedures aimed at increasing blood flow to the target limb within 4 weeks prior to randomization;
- Poor nutritional status, defined as albumin < 2.5 g/dL;
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal;
- Presence of acute biliary tract diseases such as acute cholecystitis or cholelithiasis;
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- Serum creatinine > 2 times the upper limit of normal;
- Coagulation abnormalities, recent surgery, or severe trauma;
- Diagnosed with cerebral hemorrhage within 4 weeks prior to randomization;
- 10. Received immunosuppressants, chemotherapeutic agents, radiotherapy, or systemic corticosteroids within 4 weeks prior to randomization;
- Use of any investigational drug or treatment within 4 weeks prior to randomization;
- Known allergy to curcumin or hydrogel;
- Pregnant or breastfeeding women;
- Psychiatric conditions (e.g., suicidal ideation), current or long-term alcohol or substance abuse, as determined by the patient's medical history, which in the investigator's opinion may compromise compliance;
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Diabetic foot ulcer (DFU) is a leading cause of hospitalization, disability, and mortality among diabetic patients, imposing a substantial burden on both patients and national healthcare resources. Despite the availability of comprehensive multidisciplinary treatment approaches, the wound healing rate for DFU remains only approximately 50%. Therefore, the development of novel technologies for DFU wound management represents an urgent scientific priority. Our team has been dedicated to the DFU field for over 22 years and has established a well-maintained DFU follow-up cohort. In our preliminary work, we employed multi-omics approaches to analyze the microbial community structure and metabolite profiles of DFU wounds. Furthermore, we investigated the mechanisms of turmeric-derived nanoparticle in DFU wound infection and tissue repair based on the wound microenvironment. Building upon this foundation and utilizing a turmeric-derived hydrogel formulation, we plan to conduct a randomized, multi-center, parallel-controlled, prospective clinical study (N=112). This trial aims to evaluate the efficacy of turmeric-derived nanoparticle hydrogel as an adjunct to standard care in promoting target ulcer healing and reducing recurrent infections in patients with Wagner grade 1 to 3 DFU, with the goal of optimizing clinical practice in DFU wound management.
- Conditions
- Diabete Mellitus
- Being tested
- TAG adjunctive treatment group, Hydrogel adjunctive treatment group
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAG adjunctive treatment groupDrug
For patients in the TAG group, after their wounds are cleaned by a professional dressing nurse on top of the standard treatment plan from their doctor (which may include medication, insulin, surgery, or interventional therapy), they apply the corresponding gel provided by an independent team and cover it with regular dressings, changing the gel and dressings at the usual frequency.
Hydrogel adjunctive treatment groupDrug
For patients in the control group, after a professional wound care nurse performed debridement based on the standard treatment plan from the clinician (including medication, insulin, surgery, or interventional therapy), a placebo was applied to the wound and covered with regular dressings, with medication and dressing changes done at the usual frequency.
| Study group | Role | What they receive |
|---|---|---|
| TAG group | Experimental | TAG adjunctive treatment group Receives: Drug: TAG adjunctive treatment group |
| Placebo control group | Placebo comparator | Hydrogel adjunctive treatment group Receives: Drug: Hydrogel adjunctive treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
target ulcer healing rate
Ulcer area was measured and recorded using digital photography and ImageJ software.
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start10 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818252
- Sponsor's protocol ID
- NFEC-2026-579
- Other IDs
- 2024CR009
- Status last verified
- Nov 2026
- First submitted
- 30 Aug 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
- ClinicalTrials.gov ID
- NCT07818252
- Acronym / sponsor ID
- NFEC-2026-579
- Conditions
- Diabete Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Sep 2026 (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.
Diabetic foot ulcer (DFU) is a leading cause of hospitalization, disability, and mortality among diabetic patients, imposing a substantial burden on both patients and national healthcare resources. Despite the availability of comprehensive multidisciplinary treatment approaches, the wound healing rate for DFU remains only approximately 50%. Therefore, the development of novel technologies for DFU wound management represents an urgent scientific priority. Our team has been dedicated to the DFU field for over 22 years and has established a well-maintained DFU follow-up cohort. In our preliminary work, we employed multi-omics approaches to analyze the microbial community structure and metabolite profiles of DFU wounds. Furthermore, we investigated the mechanisms of turmeric-derived nanoparticle in DFU wound infection and tissue repair based on the wound microenvironment. Building upon this foundation and utilizing a turmeric-derived hydrogel formulation, we plan to conduct a randomized, multi-center, parallel-controlled, prospective clinical study (N=112). This trial aims to evaluate the efficacy of turmeric-derived nanoparticle hydrogel as an adjunct to standard care in promoting target ulcer healing and reducing recurrent infections in patients with Wagner grade 1 to 3 DFU, with the goal of optimizing clinical practice in DFU wound management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAG group | Experimental | Drug: TAG adjunctive treatment groupTAG adjunctive treatment group |
| Placebo control group | Placebo comparator | Drug: Hydrogel adjunctive treatment groupHydrogel adjunctive treatment group |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed written informed consent obtained prior to the first study assessment;
- Male or female patients aged >= 20 and < 80 years;
- Diagnosed with diabetes mellitus (type 1 or type 2) with HbA1c < 12.0% detected during the screening period or within three months prior to randomization;
- Ankle-Brachial Index (ABI) of the target limb >= 0.8 measured during screening or within three months prior to randomization;
- The target ulcer must meet all of the following criteria: a. Wagner Ulcer Grading System grade 1 to 3; b. Located at or below the ankle; c. No infection or mild infection (as defined by IWGDF/IDSA criteria); d. Cross-sectional area after debridement between 1 and 25 cm²; e. Present for at least 4 weeks prior to randomization;
Key exclusion criteria (15 listed)
- Presence of gangrene, suppuration, or sinus tract that cannot be removed by debridement;
- Diagnosis of acute Charcot neuroarthropathy based on clinical and/or radiographic examination;
- Undergone revascularization procedures aimed at increasing blood flow to the target limb within 4 weeks prior to randomization;
- Poor nutritional status, defined as albumin < 2.5 g/dL;
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal;
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 |
|---|---|---|
| TAG adjunctive treatment groupFor patients in the TAG group, after their wounds are cleaned by a professional dressing nurse on top of the standard treatment plan from their doctor (which may include medication, insulin, surgery, or interventional therapy), they apply the corresponding gel provided by an independent team and cover it with regular dressings, changing the gel and dressings at the usual frequency. | Drug | TAG group |
| Hydrogel adjunctive treatment groupFor patients in the control group, after a professional wound care nurse performed debridement based on the standard treatment plan from the clinician (including medication, insulin, surgery, or interventional therapy), a placebo was applied to the wound and covered with regular dressings, with medication and dressing changes done at the usual frequency. | Drug | Placebo control group |
Primary outcome
target ulcer healing rate
Time frame: 12weeks
Ulcer area was measured and recorded using digital photography and ImageJ software.
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 5 Nov 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing TAG adjunctive treatment group and Hydrogel adjunctive treatment group in people with Diabete Mellitus, run by Nanfang Hospital, Southern Medical University.
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 15 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Mengchen Zou (020-62787140 ext. 18688423756, zoumc163@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
target ulcer healing rate (time frame: 12weeks). 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 5 Nov 2026.