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.
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;
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;
Parallel
TAG adjunctive treatment group
DrugFor 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 group
DrugFor 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.
target ulcer healing rate
Ulcer area was measured and recorded using digital photography and ImageJ software.
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