Periosteal Distraction With Skin Grafting for DFU (NCT07545668) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Periosteal Distraction With Skin Grafting for DFU
104 participantsStarted 2026-05-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 aff…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.