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New skin patch could replace flap surgery for leg injuries

NCT ID NCT00906672

Disease control Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compared two ways to cover deep wounds on the lower leg, ankle, or foot: a synthetic skin patch called Integra versus traditional flap surgery (moving skin from another body part). 72 patients with traumatic skin loss were enrolled. The goal was to see which method leads to fewer complications and better scar appearance.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Integra dermal substitute (a synthetic skin patch)
What this could lead to
If Integra works as well as flap surgery with fewer complications, it could offer a simpler, less invasive option for covering leg wounds.
What could go wrong
This is a small, completed Phase 3 trial with only 72 participants. The results may not apply to all wound types or patients, and Integra may still require additional surgeries.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

72 people

The number who actually took part.

Start date

Jun 2009

Finished

Jan 2014

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

15 to 80 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: * patient with skin loss traumatic or chronic wound * wound located from mid third of the leg to distal extremity of feet * with muscle and/or tendon and/or bone and/or articulation exposure * requiring a first surgical intervention for the coverage of the skin loss * patient eligible to the Integra® surgery techniques * patient with social security affiliation * written informed consent signed by the patient or representative Exclusion Criteria: * Bone fracture located in the skin loss * Non traumatic wound * Wound with muscle exposure only * Immunocompromised patient * Allergy to bovine collagen, glycosaminoglycans or silicon * patient with an healthstate that compromise the 18 months Follow-up * pregnant women / who intend to become pregnant within the 18 months of follow-up * Patient under administrative or legal supervision

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Conditions

The condition(s) this trial relates to.

ankle injury Foot Injuries Leg Injuries

As listed by the trial registrant

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

Ankle injuries Foot injuries Leg injuries

Contacts and locations

Locations

  • Saint Roch Hospital

    Nice, 06003, France

  • University Hospital

    Besançon, 25030, France

  • University Hospital

    Clermont-Ferrand, 53003, France

  • University Hospital

    Grenoble, 38043, France

  • University Hospital

    Montpellier, 34295, France

  • University Hospital

    Pointe à Pitre, 97159, France

  • Universiy Hospital Bordeaux,

    Bordeaux, France

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