Periosteal Distraction With Skin Grafting for DFU

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wound Healing; Diabetic Foot Disease
• Intervention / Treatment: Procedure: Periosteal Distraction; Procedure: Skin Grafting

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hu Zhicheng; Phone Number: 020-87755766-8235; Email: huzhch5@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 affect graft survival and function.
• Active bleeding or significant coagulation abnormality.
• Previous participation in this study at any time.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Periosteal Distraction + Skin Grafting; Patients receive periosteal distraction combined with autologous split-thickness skin grafting. Surgical procedure includes debridement, periosteal stripping and elevation (0.5-1.0 cm) using K-wire drilling, biological material coverage for vascularization, skin graft fixation, and postoperative management with delayed dressing change at day 5-7 and suture removal at day 14.	Procedure: 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.; Procedure: 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.
Active Comparator: Skin Grafting Alone; Patients receive autologous split-thickness skin grafting alone. Surgical procedure includes debridement, skin graft harvesting and transplantation, followed by postoperative management with first dressing change at day 3, suture removal at day 10-14, and gradual weight-bearing after ≥4 weeks.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft Survival Rate	Survival area of skin graft as a percentage of the original graft area at postoperative day 14. Measured using a transparent grid film (1 cm² grid) combined with digital photography. Two blinded assessors independently measure the area; a third assessor arbitrates if the difference exceeds 10%. Formula: (surviving graft area / initial graft area) × 100%.	Day 14 post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Complete Epithelialization	Number of days from surgery to complete wound closure, defined as 100% epithelial coverage without drainage or scab. Assessed daily by clinical examination combined with digital photography.	Assessed daily from surgery until closure, up to 3 months
Wound Healing Quality Assessed by BWAT Score	Bates-Jensen Wound Assessment Tool (BWAT) score at 3 months post-surgery. The scale ranges from 13 to 65 points, with higher scores indicating poorer wound healing quality. Assessed by blinded independent outcome assessors.	Month 3 post-surgery
Ulcer Recurrence Rate	Proportion of participants developing a new ulcer ≥1 cm² at the original graft site within 6 months post-surgery. Confirmed by clinical examination and photographic documentation.	Month 6 post-surgery
Foot and Ankle Function Assessed by AOFAS Score	American Orthopaedic Foot and Ankle Society (AOFAS) score at 6 months post-surgery. The scale ranges from 0 to 100 points, with higher scores indicating better functional recovery. Assessed by blinded independent outcome assessors.	Month 6 post-surgery
Quality of Life Assessed by DFS-SF Score	Diabetic Foot Ulcer Scale Short Form (DFS-SF) score at 6 months post-surgery. The scale ranges from 0 to 100 points, with higher scores indicating better quality of life. Assessed by blinded independent outcome assessors.	Month 6 post-surgery

Collaborators and Investigators

• Sponsor: Hu Zhicheng

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Surgical Procedures, Operative; Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Plastic Surgery Procedures; Tissue Transplantation; Dermatologic Surgical Procedures; Skin Transplantation
• Other Study ID Numbers: HlvlClinResProg-FAHSYSU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No