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NCT Number: NCT07252089

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.

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Key information

Conditions

Diabetic Foot Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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.

Routine Clinical Consultation and Nursing Care

Procedure

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

Primary outcomes

  1. Decisional Conflict Scale，DCS

    Time frame: When the patient was admitted to the hospital；Three days post-surgery；One month postoperatively

    The scale consists of 16 items and has undergone standardized conversion, with a total score of 100 points. A lower score indicates a lower level of decisional conflict in patients. A score >25 suggests the presence of decisional conflict during the decision-making process, while a score >37.5 indicates potential delays in decision-making

Secondary outcomes

  1. The Control Preference Scale，CPS

    Time frame: When the patient was admitted to the hospital；Three days post-surgery；One month postoperatively

    The scale consists of five options, categorized into three decision-making types: Proactive, Cooperative, and Passive. Decision-makers select the option that best aligns with their expectations based on their self-assessment.

  2. The Satisfaction with Decision Scale，SWD

    Time frame: Three days post-surgery ；One month postoperatively

    The scale consists of 6 items, allowing decision-makers to select the hospital description that best aligns with their individual circumstances.

  3. Decision Regret Scale,DRS

    Time frame: Three days post-surgery；One month postoperatively

    The scale consists of 5 items rated using a Likert 5-point rating scale, with responses ranging from "Strongly Agree" to "Strongly Disagree" assigned scores of 1 to 5 respectively. Items 2 and 4 are reverse-coded. The total score is calculated by converting the mean score of all items using the formula:

    Total Score = (Mean Score - 1) × 5 This results in a total score range of 0-20 points, where higher scores indicate greater decision regret

Sponsors and collaborators

Lead sponsor

Shiwen Hong

Other

Collaborators

  • Sir Run Run Shaw Hospital

Registry information

Official study title

Impact of Decision Support Tools on Amputation Decisions in Diabetic Foot Patients: A Quasi-Experimental Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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