Diabetic Foot DiseaseNCT07252089
Development and Application of a Decision-Making Aid Tool for Amputation Surgery in Diabetic Foot Patients Based on the Ottawa Decision Support Framework
A study testing Applications of Decision-Support Tools in Amputation Decision-Making for Diabetic Foot Patients and Routine Clinical Consultation and Nursing Care in people with Diabetic Foot Disease, run by Shiwen Hong.
Trial summary
To verify whether amputation decision-making aids can alleviate the decisional dilemma in diabetic foot patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Disease
- What is being tested?
- Applications of Decision-Support Tools in Amputation Decision-Making for Diabetic Foot Patients and Routine Clinical Consultation and Nursing Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- History of psychiatric disorders with inability to cooperate during communication.
- Concomitant severe complications.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Foot Disease
- Being tested
- Applications of Decision-Support Tools in Amputation Decision-Making for Diabetic Foot Patients, Routine Clinical Consultation and Nursing Care
- Keywords
- Diabetic Foot Amputation Decision-Making Aid Tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applications of Decision-Support Tools in Amputation Decision-Making for Diabetic Foot PatientsProcedure or surgery
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 CareProcedure or surgery
Patients received routine clinical consultation and nursing care before and after random assignment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Routine Clinical Consultation and Nursing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: When the patient was admitted to the hospital；Three days post-surgery；One month postoperatively
Secondary outcomes (3)
The Control Preference Scale，CPS
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.
Measured: When the patient was admitted to the hospital；Three days post-surgery；One month postoperatively
The Satisfaction with Decision Scale，SWD
The scale consists of 6 items, allowing decision-makers to select the hospital description that best aligns with their individual circumstances.
Measured: Three days post-surgery ；One month postoperatively
Decision Regret Scale,DRS
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
Measured: Three days post-surgery；One month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 May 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiwen Hong
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital
- Responsible party
- Sponsor-investigator, Shiwen Hong, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252089
- Sponsor's protocol ID
- SRRSH No. 0805 (2025)
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Decision Support Tools on Amputation Decisions in Diabetic Foot Patients: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07252089
- Acronym / sponsor ID
- SRRSH No. 0805 (2025)
- Conditions
- Diabetic Foot Disease
- Keywords
- Diabetic Foot Amputation Decision-Making Aid Tool
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shiwen HongUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Procedure: Applications of Decision-Support Tools in Amputation Decision-Making for Diabetic Foot PatientsIn 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. |
| Control group | Placebo comparator | Procedure: Routine Clinical Consultation and Nursing CarePatients received routine clinical consultation and nursing care before and after random assignment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- History of psychiatric disorders with inability to cooperate during communication.
- Concomitant severe complications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Applications of Decision-Support Tools in Amputation Decision-Making for Diabetic Foot PatientsIn 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 or surgery | Experimental group |
| Routine Clinical Consultation and Nursing CarePatients received routine clinical consultation and nursing care before and after random assignment. | Procedure or surgery | Control group |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Applications of Decision-Support Tools in Amputation Decision-Making for Diabetic Foot Patients and Routine Clinical Consultation and Nursing Care in people with Diabetic Foot Disease, run by Shiwen Hong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict Scale，DCS (time frame: When the patient was admitted to the hospital；Three days post-surgery；One month postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025; AzTrials last refreshed its copy on 30 Oct 2026.