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5,000 patients to help reveal which wound dressings heal best

NCT ID NCT06328010

Knowledge-focused Sponsor: Siddhey LLC 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational registry will follow 5,000 adults with various wounds—like diabetic foot ulcers, burns, or surgical wounds—to see how different treatments (e.g., hydrocolloid, foam, silver dressings) perform in everyday medical settings. Researchers will measure wound healing, pain, and side effects. The goal is to gather real-world data, not to test a new product.

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.

Participants

About 5,000 people

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

Started

Apr 2024

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

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.

Who is studied

Adults with wounds/injuries

Ages

18 years and older

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 1. Subject is male or female ≥18 years of age. 2. Subject has an ulcer (Diabetic foot ulcer, Venous stasis ulcer, etc.), injury (trauma, post -surgical, MOHS treatment), Burns injury, and/or other acute/chronic wounds. 3. Subject has clinical documentation of no visible wound improvement in the wound after 4 weeks of standard of care therapy. 4. Study wound is a minimum of 1 cm2 at Visit 1. 5. The subject is able and willing to follow the protocol requirements. 6. The subject has signed the informed consent form. 7. Subject has adequate circulation to the affected extremity. Note: This will be confirmed by vascular perfusion assessment performed prior to enrollment, if clinically indicated per Institutional standard of care. Exclusion Criteria 1. Subject has a known life expectancy \< 1 year. 2. Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver, or pulmonary disease, lupus, palliative care or sickle cell anemia. 3. Subject currently being treated for an active malignant disease or subjects with a history of malignancy within the wound. 4. Known contraindications to advance therapy tissues or products. 5. Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10 mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the wound surface within one month prior to Visit 1. 6. Affected extremity requiring hyperbaric oxygen during the study or within 2 weeks of Visit 1. 7. Known HbA1c \>12%. 8. Subjects who are pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

Accidental Injuries burn chronic ulcer of skin decubitus ulcer Degloving Injuries injury ulcer of lower limbs Varicose Ulcer

As listed by the trial registrant

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

Burns Degloving injuries Diabetic foot ulcer mixed Injury and wounds Mohs surgery Non-healing wound Pressure ulcers, bedsores, decubitus ulcer Trauma injury Venous leg ulcer Wounds and injuries

How to take part

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

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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

  • Metro Foot & Ankle

    Tempe, Arizona, 85282, United States

  • PerfectFeetCare Podiatry Centers

    Hialeah, Florida, 33012, United States

  • PerfectFeetCare Podiatry Centers

    Miami, Florida, 33175, United States

  • Pima Foot and Ankle Surgery LLC

    Tucson, Arizona, 85718, United States

  • Pulse Cardiovascular Institute

    Scottsdale, Arizona, 85251, United States

  • Richard C. Galperin, DPM, PA

    Dallas, Texas, 75208, United States

  • Rubin Foot & Ankle

    Naperville, Illinois, 60563, United States

  • Signature Health Medical Group

    Riverside, California, 92503, United States

  • The Rache Clinic

    Las Vegas, Nevada, 89147, United States

  • The Schottenstein Center

    Hallandale, Florida, 33009, United States

  • The Schottenstein Center

    Miami, Florida, 33137, United States

  • Wigley Feet

    North Miami Beach, Florida, 33162, United States

More trials for these conditions

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