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

Shiwen Hong

Status: Begins enrollment in 2 months

Conditions: Diabetic Foot Disease

Treatments: Procedure: Routine Clinical Consultation and Nursing Care; Procedure: Applications of Decision-Support Tools in Amputation Decision-Making for Diabetic Foot Patients

Study type: Interventional

Funder types: Other

Identifiers

NCT07252089

SRRSH No. 0805 (2025)

Details and patient eligibility

About

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

Full description

Through a clinical controlled study, the nurse-assisted intervention group utilized the Decision-Making Aid Tool for Amputation in Diabetic Foot Patientsto assess patients' treatment choice stages, provide disease-related knowledge, and clarify the advantages and disadvantages of different treatment options. This tool also helped patients articulate their values and preference biases. Subsequently, a questionnaire survey was conducted to evaluate decisional conflict, decisional expectations, and decisional satisfaction between the two groups, aiming to assess the tool's application efficacy.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetic foot ulcers with Wagner grade 4 or higher gangrene. Diabetic foot ulcers with Wagner grade 3 accompanied by severe infection or systemic symptoms; severe local infections, or chronic osteomyelitis causing functional impairment of the limb.

Patients with lower extremity vascular disease showing progression despite systemic treatment.

IWGDF stage 3 severe infections (characterized by loss of protective sensation or peripheral arterial disease, with at least one of the following: history of foot ulcer, lower limb amputation, or end-stage renal disease).

Exclusion criteria

• History of psychiatric disorders with inability to cooperate during communication.

Concomitant severe complications.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Experimental group

Active Comparator group

Description:

In addition to receiving routine clinical consultations and nursing care identical to the control group, the intervention group will utilize an electronic decision-making aid for diabetic foot amputation. We will design this electronic tool and deliver it to participants via a WeChat Mini Program. Patients will be instructed to spend no more than 60 minutes using the tool, with researchers supervising their sessions and providing assistance as needed. During the study period, the electronic decision-making aid will remain confidential and accessible only to the intervention group, with restricted access for physicians and non-intervention patients.

Treatment:

Procedure: Applications of Decision-Support Tools in Amputation Decision-Making for Diabetic Foot Patients

Control group

Placebo Comparator group

Description:

Patients received routine clinical consultation and nursing care before and after random assignment.

Treatment:

Procedure: Routine Clinical Consultation and Nursing Care