Diabetic Foot Disease

6

Review clinical trials related to Diabetic Foot Disease. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Periosteal Distraction With Skin Grafting for DFU

This study is a single-center, prospective, randomized controlled trial aimed at evaluating whether periosteal distraction combined with autologous split-thickness skin grafting can significantly improve graft survival rate at postoperative day 14 compared with skin grafting alone in patients with diabetic foot ulcers (Wagner grade 2-3 or post-amputation). A total of 104 eligible patients will be randomly assigned to either the experimental group (periosteal distraction + skin grafting, n=52) or the control group (skin grafting alone, n=52). Secondary outcomes include time to complete epithelialization, wound healing quality (BWAT score at 3 months), ulcer recurrence rate (at 6 months), foot function (AOFAS score), quality of life (DFS-SF score), and safety profile. This study aims to address the critical clinical bottleneck of poor graft survival in ischemic wound environments, providing a novel, minimally invasive, and synergistic treatment paradigm for diabetic foot ulcers.

Participants needed: 104
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: Hu ZhichengUpdated: Apr 22, 2026
Eligibility criteria

Age ≥18 years on the day of signing informed consent. [+8]

Poorly controlled hyperglycemia (e.g., HbA1c >12.0%). [+10]

Status: Not yet recruiting

Detection of Diabetic Foot Skin Damage Using Plantar Mechanical Parameters

Diabetes represents one of the major chronic diseases, with diabetic ulcers being a significant adverse prognosis. Approximately 80% of lower limb amputations are attributed to diabetic foot ulcers, which constitute a primary cause of patient disability and mortality, while also imposing a substantial burden on healthcare systems. Although standardized Western medical protocols for diabetic foot management exist, clinical outcomes remain suboptimal. The amputation rate due to diabetic foot ulcers continues to rise annually, underscoring the urgent need for novel and effective interventions to address this condition. Quantitative assessment of cutaneous biomechanical parameters may indirectly reflect the cumulative damage inflicted by diabetes on foot tissues. Such evaluation provides critical guidance for predicting susceptibility to recurrent ulceration and determining the necessity of enhanced offloading strategies to prevent ulcer development. By applying specific mechanical loads to the skin and measuring deformation, rebound characteristics, and displacement dynamics under pressure, it becomes possible to quantitatively evaluate parameters such as elastic modulus and viscoelastic properties. This case-control study aims to investigate the feasibility of utilizing plantar skin quantitative mechanical parameters as objective biomarkers for biomechanical impairment in diabetic foot. Furthermore, it seeks to establish a standardized operating procedure (SOP) for quantitative measurements tailored to diabetic foot scenarios. The study is designed to bridge critical evidence gaps between theoretical consensus and clinically applicable quantitative tools, demonstrating clear innovation and potential clinical value.

Participants needed: 200
Trial details
Age: 18-80Biological sex: AllType: ObservationalSponsor: Peking University Third HospitalUpdated: Mar 13, 2026
Eligibility criteria

For healthy one: Fasting blood glucose < 6.1 mmol/L and glycated hemoglobin < 6.... [+1]

For healthy one: (1) History of foot surgery, trauma, or fractures resulting in... [+1]

Status: Not yet recruiting

Development and Application of a Decision-Making Aid Tool for Amputation Surgery in Diabetic Foot Patients Based on the Ottawa Decision Support Framework

To verify whether amputation decision-making aids can alleviate the decisional dilemma in diabetic foot patients.

Participants needed: 80
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Shiwen HongUpdated: Nov 26, 2025
Eligibility criteria

Diabetic foot ulcers with Wagner grade 4 or higher gangrene. Diabetic foot ulcer...

History of psychiatric disorders with inability to cooperate during communicatio...

Status: Not yet recruiting

Implementation of a Diabetic Foot Prevention Strategy in Primary Care (iMplanta Study)

The goal of this two-arm cluster randomised controlled trial (RCT) is to evaluate the effectiveness of a new implementation strategy based on the ImM model for the Protocol of assistance to the person with diabetic foot (PAPDF) of the Balearic Islands Health Service in reducing complications of diabetic foot, compared to the current implementation strategy, in the primary care centers of Majorca. As secondary objectives we aim 1. To determine the reach of the implementation strategy in the GAPM primary care centers, 2.To compare the effectiveness of the PAPDF versus usual care in preventing diabetic foot complications, 3. To identify the number of healthcare professionals adhering to the implementation strategy and 4. To assess the sustainability of the implementation strategy over time.

Participants needed: 1,520
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of the Balearic IslandsUpdated: Jun 29, 2025Locations: 1
Eligibility criteria

Diagnosis of type 1 or type 2 diabetes mellitus. [+2]

Patients with gestational diabetes. [+2]

Status: Not yet recruiting

Identification of Pathogenic Bacteria of Diabetes Foot Ulcer

The objective of this study is to design and develop a gene chip for detecting pathogenic bacteria in diabetic foot infection wounds. This innovative gene chip technology enables rapid and accurate identification of pathogens at the site of infection by detecting the 16SrDNA sequence of pathogenic bacteria. Diabetic foot infection is a common serious complication in diabetic patients, often accompanied by complex pathogenic bacteria population, and due to the variety of infection types, traditional pathogen detection methods are time-consuming and low accuracy, patients may miss the best treatment opportunity. Now commonly used genetic identification of pathogenic bacteria often find a variety of bacteria, resulting in the actual pathogenic bacteria difficult to judge.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Shanghai Jiao Tong University School of MedicineUpdated: Jan 16, 2025Locations: 1Duration: 1 Year
Eligibility criteria

Age ≥ 18 years old [+5]

Patients with undiagnosed diabetic foot infection [+5]

Status: Not yet recruiting

Predictors of Diabetic Foot Outcome in Chronic Kidney Disease Patients

Individuals with diabetic neuropathy and Chronic kidney disease (CKD) are 15 times more likely to have a non-traumatic lower extremity amputation compared to those with DM alone . The incidence of DF and its evolution appear to be proportionally related to the stage of CKD . One of the most important causes is vascular calcification, which is common in patients with atherosclerosis, DM, CKD, and elderly . Various factors, including age, gender, infection severity, local ischemia, diabetes duration, neuropathy, and blood sugar control, are considered potential predictors for DF outcome. However, there remains a lack of complete this study aim to Assessment of predictors of diabetic foot development and outcome in chronic kidney disease patients.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Assiut UniversityUpdated: Nov 12, 2024
Eligibility criteria

- Age ≥18 years old. [+2]

- Patients on dialysis or CKD stage 5 (GFR < 15 ml/min) [+3]