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Not yet recruitingNCT07818252Updated Nov 5, 2026

Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds

An interventional study of TAG adjunctive treatment group and Hydrogel adjunctive treatment group in Diabete Mellitus, sponsored by Nanfang Hospital, Southern Medical University. Not yet recruiting. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Nanfang Hospital, Southern Medical University · Not applicable, Interventional, and Treatment

Updated Nov 5, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
20 Years to 79 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Diabete Mellitus

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03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's planned enrollment of 112 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 490 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed written 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 \< 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 , negative pregnancy test and not currently breastfeeding at the screening visit;
  • Willing and able to attend scheduled visits and comply with study procedures;

Exclusion criteria

Exclusion Criteria:

  • 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;
  • (AST) and/or alanine aminotransferase (ALT) > 3 times the ;
  • Presence of acute biliary tract diseases such as acute cholecystitis or cholelithiasis;
  • 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 , chemotherapeutic agents, radiotherapy, or systemic within 4 weeks prior to randomization;
  • Use of any 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.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

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Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

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Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
112 participants (estimated)

Study arms

  • Experimental
    TAG group

    TAG adjunctive treatment group

    Drug: TAG adjunctive treatment group

  • Placebo comparator
    Placebo control group

    Hydrogel adjunctive treatment group

    Drug: Hydrogel adjunctive treatment group

Interventions

  • DrugTAG adjunctive treatment group

    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.

  • DrugHydrogel adjunctive treatment group

    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.

06

What researchers measure

Primary outcomes

  1. target ulcer healing rate

    Ulcer area was measured and recorded using digital photography and ImageJ software.

    Time frame: 12weeks

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Start date
Sep 1, 2026→Nov 10, 2026
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Start date Sep 1, 2026→Nov 10, 2026
    + 2 other changes: verification date and description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07818252
Responsible party
Sponsor
First posted
Sep 14, 2026
Start date
Nov 10, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Mengchen Zou
Contact
zoumc163@163.com
020-62787140 ext. 18688423756

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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