Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Bone-Stretching trick may help heal diabetic foot wounds

NCT ID NCT07545668

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 104 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Diabetic foot disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.