Skip to content

Effectiveness of a Self-management Program for Patients with Diabetic Foot Ulcers: A Randomized Controlled Trial

Effectiveness of a Self-management Program for Patients with Diabetic Foot Ulcers: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109488
Enrollment
Unknown
Registered
2025-09-19
Start date
2025-08-12
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic foot ulcer

Interventions

intervention group:Patients in the intervention group and their family members will participate in a single 60-minute face-to-face shared decision-making (SDM) session. The intervention will be jointl
second, identify key issues requiring joint decision-making, such as prevention or mitigation of cardiorenal comorbidities, selection of offloading methods for the foot, daily foot care, and adjustmen
third, provide systematic information on available management options, supplemented with charts and decision aids to enhance understanding
fourth, assess the values, lifestyle preferences, and feasibility considerations of the patient and caregiver
fifth, jointly determine the optimal management pathway, formulate an actionable individualized plan, and set stage-specific goals
and sixth, evaluate the effectiveness of the intervention through outpatient visits or remote follow-up at 1, 2, and 3 months after the session, with timely adjustments to management content as needed

Sponsors

Sun Yat-sen Memorial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged >=18 and child/parent > sibling) who is a relative and does not receive direct financial compensation for caregiving. The caregiver must provide daily care, accompany the patient to outpatient follow-ups, be proficient in using the WeChat app on a smartphone, and be able to perform basic wound care tasks such as taking photos, cleaning, and dressing the wound after training; 5. Provision of written informed consent.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women. 2.Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >5 times the upper limit of normal, or serum creatinine > 4 times the upper limit of normal. 3.Receipt of immunosuppressants, chemotherapeutic agents, radiotherapy, or systemic corticosteroid therapy within the past 4 weeks. 4.Presence of progressive malignant tumor, severe malnutrition, or severe cardiopulmonary disease. 5.Patients with iodine allergy or thyroid dysfunction. 6.Use of medications that impair wound healing, such as dipeptidyl peptidase-4 (DPP-4) inhibitors. 7.Emotional instability, cognitive impairment, or current/long-term alcohol or substance abuse. 8.Foot ulcer with any of the following characteristics: involvement of multiple planes, severe infection or purely ischemic ulcer, active bleeding, or the presence of gangrene, suppuration, or sinus tract that cannot be removed by debridement.

Design outcomes

Secondary

MeasureTime frame
self-management behavior;shared-decision making;knowledge;social support;nutrition;quality of life;

Primary

MeasureTime frame
Wound healing status of the foot ulcer;Cardiovascular–Kidney–Metabolic Health Index;

Countries

China

Contacts

Public ContactYang Chuan

Sun Yat-sen Memorial Hospital

shishp5@mail2.sysu.edu.cn+86 136 4024 2307

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026