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

NCT07252089 | Not Yet Recruiting

• 1 other identifier: SRRSH No. 0805 (2025)
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetic Foot Disease

Keywords

Diabetic Foot Amputation Decision-Making Aid Tool

Outcome Measures

Primary Outcomes (1)

• Decisional Conflict Scale，DCS

  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 Outcomes (3)

• The Control Preference Scale，CPS

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

• The Satisfaction with Decision Scale，SWD

  Three days post-surgery ；One month postoperatively

• Decision Regret Scale,DRS

  Three days post-surgery；One month postoperatively

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

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

Control group

PLACEBO COMPARATOR

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

Procedure: Routine Clinical Consultation and Nursing Care

Interventions

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.

Experimental group

Routine Clinical Consultation and Nursing Care PROCEDURE

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Shiwen Hong: lead
• Sir Run Run Shaw Hospital: collaborator

MeSH Terms

Interventions

Nursing Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ShiWen Hongª (MS)nursing department, sir run run shaw hospital,zhejiang university school of medicine.Hangzhou, Zhejiang Province, China

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 26, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share