Diabetic Foot DiseaseNCT07545668
Periosteal Distraction With Skin Grafting for DFU
A study testing Periosteal Distraction and Skin Grafting in people with Diabetic Foot Disease and Wound Healing, run by Hu Zhicheng.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Foot Disease, Wound Healing
- What is being tested?
- Periosteal Distraction and Skin Grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Diabetic Foot Disease, Wound Healing
- Being tested
- Periosteal Distraction, Skin Grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periosteal DistractionProcedure or surgery
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.
Skin GraftingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Skin Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Day 14 post-surgery
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 6 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hu Zhicheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hu Zhicheng, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545668
- Sponsor's protocol ID
- HlvlClinResProg-FAHSYSU
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periosteal Distraction Combined With Skin Grafting for the Treatment of Diabetic Foot Ulcers: A Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT07545668
- Acronym / sponsor ID
- HlvlClinResProg-FAHSYSU
- Conditions
- Diabetic Foot Disease, Wound Healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Hu ZhichengUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periosteal Distraction + Skin Grafting | Experimental | Procedure: Periosteal Distraction, Procedure: Skin GraftingPatients 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. |
| Skin Grafting Alone | Active comparator | Procedure: Skin GraftingPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periosteal DistractionA 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 or surgery | Periosteal Distraction + Skin Grafting |
| Skin GraftingAutologous 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. | Procedure or surgery | Periosteal Distraction + Skin Grafting, Skin Grafting Alone |
Primary outcome
Graft Survival Rate
Time frame: Day 14 post-surgery
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%.
5 secondary outcomes
Time to Complete Epithelialization
Time frame: Assessed daily from surgery until closure, up to 3 months
Wound Healing Quality Assessed by BWAT Score
Time frame: Month 3 post-surgery
Ulcer Recurrence Rate
Time frame: Month 6 post-surgery
Foot and Ankle Function Assessed by AOFAS Score
Time frame: Month 6 post-surgery
Quality of Life Assessed by DFS-SF Score
Time frame: Month 6 post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Periosteal Distraction and Skin Grafting in people with Diabetic Foot Disease and Wound Healing, run by Hu Zhicheng.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hu Zhicheng (020-87755766-8235, huzhch5@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft Survival Rate (time frame: Day 14 post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.