Diabete Mellitus
Conditions
Brief 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 and a comprehensive biospecimen repository. 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 aerogel (TAG) in DFU wound infection and tissue repair based on the wound microenvironment. These findings were published in Advanced Science in 2024.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=54). This trial aims to evaluate the efficacy of TAG 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.
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.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
declarant
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* 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;
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; * 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; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| target ulcer healing rate | 12weeks | Ulcer area was measured and recorded using digital photography and ImageJ software. |
Contacts
CONTACTMengchen Zou
Outcome results
None listed