Periosteal Distraction With Skin Grafting for DFU

NCT07545668 | Not Yet Recruiting

• 1 other identifier: HlvlClinResProg-FAHSYSU
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetic Foot Disease; Wound Healing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to Complete Epithelialization

  Assessed daily from surgery until closure, up to 3 months

• Wound Healing Quality Assessed by BWAT Score

  Month 3 post-surgery

• Ulcer Recurrence Rate

  Month 6 post-surgery

• Foot and Ankle Function Assessed by AOFAS Score

  Month 6 post-surgery

• Quality of Life Assessed by DFS-SF Score

  Month 6 post-surgery

Study Arms (2)

Periosteal Distraction + Skin Grafting

EXPERIMENTAL

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; Procedure: Skin Grafting

Skin Grafting Alone

ACTIVE COMPARATOR

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

Interventions

Periosteal Distraction PROCEDURE

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.

Periosteal Distraction + Skin Grafting

Skin Grafting PROCEDURE

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.

Periosteal Distraction + Skin Grafting; Skin Grafting Alone

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hu Zhicheng: lead

MeSH Terms

Interventions

Skin Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative; Transplantation

Central Study Contacts

Hu Zhicheng

CONTACT

020-87755766-8235; huzhch5@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The First Affiliated Hospital of Sun Yat-sen University

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share