Sheep membrane may help cover exposed bone faster
NCT ID NCT07385313
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a special wound dressing made from sheep stomach lining, used with a vacuum device, to see if it helps cover exposed bone or tendon faster than the vacuum device alone. About 30 adults with soft tissue wounds on an arm or leg will take part. The goal is to see if the combination leads to quicker tissue coverage and fewer complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ovine forestomach matrix (a sheep-derived wound dressing) used with negative pressure wound therapy
- What this could lead to
- If it works, this could offer a faster way to cover exposed bone or tendon in complex wounds, reducing infection risk and need for surgery.
- What could go wrong
- This is a small early-phase trial with only 30 participants, so results may not apply to everyone. The device may not speed healing more than standard care.
Why investors are watching
AROA Biosurgery is running a small Phase 4 trial testing whether its ovine forestomach matrix product, combined with negative pressure wound therapy, covers exposed tissue faster than the therapy alone. For a micro-cap company, a positive readout in this 30-patient study could validate the product's clinical benefit and support broader adoption in wound care.
If it works: A positive result could strengthen AROA's evidence base for its wound care product, potentially encouraging more surgeons to use it and supporting commercial growth.
If it fails: The trial could fail to show a meaningful difference, or the small size could limit the reliability of the results. Trials often fail, and a negative outcome could hurt the company's credibility and sales prospects.
AI-written from the trial record. Speculative, and not investment advice.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 years and older
- 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.
Show the full entry requirements Hide 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: * Patients will be considered eligible for the study based on the following criteria: * Willing and able to provide written informed consent and to comply with the requirements of the Clinical Investigational Plan * Male or female patients aged 18 years or above * Patient is requiring reconstruction of a full thickness soft tissue defect, that includes exposed structures (bone, tendon, or neurovascular), upper or lower extremity. * Total defect size, range 25 to 800 cm2 Exclusion Criteria: * Patients will be excluded from the study based on the following criteria: * Patients with known sensitivity to ovine (sheep) derived material * Pregnant or lactating females. * Patients who are prisoners. * Patients who are likely not to complete the study. * Patients who, in the opinion of the Investigator, are unlikely to comply with the protocol. * Patients currently participating in or have participated in another clinical study within the past 30 days prior to enrolment that at the discretion of the Investigator makes them unsuitable for inclusion in the study. * Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study. * Any medical condition, recent treatment or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study. * Obesity (BMI\>45) * Blood glucose ≥350 mg/dL at admission * History of chronic peripheral vascular disease * Current immunosuppression * Recent neoadjuvant chemotherapy or radiotherapy * Previous or concurrent application of a cell/tissue-based product (CTP, or skin substitute) at the wound site within 30 days of the Screening Visit * Defect is a third degree burn
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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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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The University of Texas Health Science Center at San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
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University of Colorado-Anschutz Medical Campus
RECRUITINGAurora, Colorado, 80045, United States
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