Risk Perception Intervention for High-Risk Diabetic Foot

Starting soon · Not applicable

Conditions studied: Diabetes Mellitus, Diabetic Foot Ulcer (DFU), Risk Perception, Peripheral Neuropathy With Type 2 Diabetes

In brief

This study aims to evaluate the effect of health education based on information framing effects on foot ulcer risk perception in patients at high risk of diabetic foot. Study Design: A randomized controlled trial with three groups: Experimental Group 1 (Gain-Framed): Participants received a benefit framing message that emphasized the benefits of standardized foot care in reducing the likelihood and severity of foot ulcers, with an aim to reshape patients' perception of risk. Experimental Group 2 (Loss-Framed):Participants received a loss frame message that emphasized that neglecting foot care would increase the likelihood and severity of foot ulcers. The message was designed to awaken patients' awareness of crisis and risk perception. Control Group (Routine Messaging):Participants received the usual content of care in the endocrinology department without a specific framework. Participants: Diabetic foot patients at high risk from experimental group 1, experimental group 2, and control group 3. Inclusion criteria included adults with a diagnosis of diabetic foot at high risk. Intervention: The Total Study Period consisted of an intervention phase and a follow-up phase. The intervention phase started at the time of enrollment and lasted until the fourth week after discharge. The follow-up period lasted for 3 months. Data on local indicators were collected at baseline/before the intervention (T0), immediately after the intervention (T1), 1 month after the intervention (T2) and 3 months after the intervention (T3). Outcome Measures: Primary Outcomes: Foot ulcer risk perception: Assessed using The Tripartite Model of Risk Perception Scale. Secondary Outcomes: Foot care behavior score: Assessed using The Nottingham Foot Care Assessment Scale; Self-efficacy: Assessed using The Diabetes Self-Efficacy Scale; Intention to delay seeking medical help score:Assessed using the Questionnaire on Intention to Delay Seeking Medical Care for Patients with High-Risk Diabetic Foot; the incidence/recurrence rate of foot ulcers, and various laboratory indicators.

Key facts

Study ID

NCT07581262

Run by

The Third Affiliated Hospital of Soochow University

People needed

90

Starts

2026-05-01

Expected to finish

2026-12-31

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old with good communication and cognitive abilities.
• Meet the World Health Organization (WHO) diagnostic criteria for Type 1 or Type 2 Diabetes Mellitus.
• Meet the diagnostic criteria for high-risk diabetic foot according to the International Working Group on the Diabetic Foot (IWGDF) 2023 standards.
• Proficient in the use of a smartphone and related applications (e.g., WeChat).
• Voluntarily participate in the study and provide signed informed consent.

You may not qualify if…

• Patients with impaired consciousness, severe organ dysfunction, or other physical disabilities that lead to being bedbound or unable to perform foot care.
• Patients with peripheral neuropathy caused by non-diabetic factors (e.g., toxic, nutritional, or hereditary neuropathies).
• Patients with gestational diabetes or those with pre-existing diabetes who are currently pregnant.

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.