Periosteal Distraction With Skin Grafting for DFU, 104-Patient Randomized Trial
Summary
A single-center, prospective, randomized controlled trial registered on ClinicalTrials.gov (NCT07545668) will evaluate whether periosteal distraction combined with autologous split-thickness skin grafting improves graft survival at postoperative day 14 compared with skin grafting alone in 104 patients with diabetic foot ulcers (Wagner grade 2-3 or post-amputation). Participants are randomized 1:1 into experimental (n=52) and control (n=52) groups, with secondary outcomes including time to complete epithelialization, wound healing quality (BWAT score at 3 months), ulcer recurrence at 6 months, foot function (AOFAS score), quality of life (DFS-SF score), and safety profile. The study addresses poor graft survival in ischemic wound environments and aims to establish a novel minimally invasive treatment paradigm for diabetic foot ulcers.
“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).”
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What changed
This document registers a new randomized controlled trial (NCT07545668) on ClinicalTrials.gov evaluating periosteal distraction combined with skin grafting for diabetic foot ulcers. The trial will enroll 104 eligible patients randomized equally between experimental and control groups, studying graft survival as the primary outcome at postoperative day 14.
For healthcare providers and clinical researchers, this trial registration signals emerging evidence development in ischemic wound management for diabetic foot ulcers. While the registration itself does not create compliance obligations, it may inform future clinical practice guidelines and represents an area of active investigation for treatment-refractory wounds.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Periosteal Distraction With Skin Grafting for DFU
N/A NCT07545668 Kind: NA Apr 22, 2026
Abstract
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.
Conditions: Diabetic Foot Disease, Wound Healing
Interventions: Periosteal Distraction, Skin Grafting
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