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

November 19, 2025 updated by: Shiwen Hong

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Experimental group
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.
Procedure: Applications of Decision-Support Tools in Amputation Decision-Making for Diabetic Foot Patients
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.
Placebo Comparator: Control group
Patients received routine clinical consultation and nursing care before and after random assignment.
Procedure: Routine Clinical Consultation and Nursing Care
Patients received routine clinical consultation and nursing care before and after random assignment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
When the patient was admitted to the hospital；Three days post-surgery；One month postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
When the patient was admitted to the hospital；Three days post-surgery；One month postoperatively
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.
Three days post-surgery ；One month postoperatively
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
Three days post-surgery；One month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiwen Hong

Collaborators

Sir Run Run Shaw Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRRSH No. 0805 (2025)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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