Periosteal Distraction With Skin Grafting for DFU

Официальное название

Periosteal Distraction Combined With Skin Grafting for the Treatment of Diabetic Foot Ulcers: A Prospective, Randomized, Controlled Study

Обзор

This study is a single-center, prospective, randomized controlled trial aimed at evaluating whether periosteal distraction combined with autologous split-thickness skin grafting can significantly improve graft survival rate at postoperative day 14 compared with skin grafting alone in patients with diabetic foot ulcers (Wagner grade 2-3 or post-amputation). A total of 104 eligible patients will be randomly assigned to either the experimental group (periosteal distraction + skin grafting, n=52) or the control group (skin grafting alone, n=52). Secondary outcomes include time to complete epithelialization, wound healing quality (BWAT score at 3 months), ulcer recurrence rate (at 6 months), foot function (AOFAS score), quality of life (DFS-SF score), and safety profile. This study aims to address the critical clinical bottleneck of poor graft survival in ischemic wound environments, providing a novel, minimally invasive, and synergistic treatment paradigm for diabetic foot ulcers.

Вмешательства

• Процедура Periosteal Distraction
  A minimally invasive surgical technique based on the Ilizarov tension-stress principle. The periosteum is circumferentially stripped 1-1.5 cm from the wound edge, elevated 0.5-1.0 cm using K-wire drilling and suspension, followed by biological material coverage to promote vascularization. The distraction is applied at a rate of 1 mm per day to activate cell proliferation and angiogenesis.
• Процедура Skin Grafting
  Autologous split-thickness skin harvested using a dermatome, trimmed to match the wound size, and transplanted onto the wound bed after debridement. The graft is secured with vaseline gauze and antibiotic dressing, followed by pressure bandaging and splint immobilization.

Первичные конечные точки

• Graft Survival Rate [Срок оценки: Day 14 post-surgery]

Вторичные конечные точки (5)

• Time to Complete Epithelialization [Срок оценки: Assessed daily from surgery until closure, up to 3 months]
• Wound Healing Quality Assessed by BWAT Score [Срок оценки: Month 3 post-surgery]
• Ulcer Recurrence Rate [Срок оценки: Month 6 post-surgery]
• Foot and Ankle Function Assessed by AOFAS Score [Срок оценки: Month 6 post-surgery]
• Quality of Life Assessed by DFS-SF Score [Срок оценки: Month 6 post-surgery]

Критерии участия

Критерии включения

• Age ≥18 years on the day of signing informed consent.
• Diagnosed with type 2 diabetes mellitus.
• Diabetic foot ulcer persisting for ≥2 weeks.
• Wagner grade 2 or 3; or post-amputation (Wagner grade 4-5) wound requiring skin grafting.
• Wound area ≥3 cm².
• Brachial-ankle index between 0.71 and 1.30.
• Hemodynamically stable with routine examinations indicating tolerance to surgery.
• Mentally competent, able to follow medical advice, and willing to attend scheduled follow-up visits.
• Understand and voluntarily sign informed consent to participate in this trial.

Критерии исключения

• Poorly controlled hyperglycemia (e.g., HbA1c >12.0%).
• Immunosuppression due to underlying disease, long-term immunosuppressive therapy, or high-dose glucocorticoids (e.g., ≥40 mg prednisone or equivalent daily for ≥2 weeks) during screening.
• Preexisting conditions affecting wound healing (e.g., malignancy, autoimmune disease).
• Severe uncontrolled systemic disease or acute systemic infection; concomitant severe cardiac, pulmonary, or cerebral disease.
• Psychiatric disorders.
• Deemed unsuitable for inclusion by the investigator.
• Pregnancy, unwillingness to use adequate contraception in women of childbearing potential, lactation, or planning pregnancy within 1 month after study completion.
• Active osteomyelitis in the target ulcer without adequate debridement and/or antibiotic treatment.
• Significant uncorrected biomechanical deformity expected to severely affect graft survival and function.
• Active bleeding or significant coagulation abnormality.
• Previous participation in this study at any time.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07545668 · HlvlClinResProg-FAHSYSU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗