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Not yet recruiting NCT07252089

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

No phase Interventional Diabetic Foot Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Applications of Decision-Support Tools in Amputation Decision-Making for Diabetic Foot Patients, Routine Clinical Consultation and Nursing Care.
Who it may be relevant to
Registry conditions: Diabetic Foot Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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.

Interventions

  • 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 deci
  • Procedure Routine Clinical Consultation and Nursing Care
    Patients received routine clinical consultation and nursing care before and after random assignment.

Primary outcome measures

  • Decisional Conflict Scale，DCS [Time frame: When the patient was admitted to the hospital；Three days post-surgery；One month postoperatively]
Secondary outcome measures (3)
  • The Control Preference Scale，CPS [Time frame: 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]
  • Decision Regret Scale,DRS [Time frame: Three days post-surgery；One month postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07252089 · SRRSH No. 0805 (2025)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗