Bone-Stretching trick may help heal diabetic foot wounds
NCT ID NCT07545668
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if a new surgical method—gently stretching the bone under the wound and then placing a skin graft—can help diabetic foot ulcers heal better than skin grafts alone. About 104 adults with hard-to-heal foot sores will be randomly assigned to get either the combined treatment or just the skin graft. The main goal is to see if more of the graft survives after 14 days, with follow-ups on wound closure, quality of life, and safety.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 104 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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How to take part
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The official record
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