Clinical Registry Collecting Real World Evidence on Wound Care Treatments

Enrolling by invitation

Conditions studied: Wounds and Injuries, Burns, Mohs Surgery, Diabetic Foot Ulcer Mixed, Venous Leg Ulcer, Non-healing Wound, Trauma Injury, Injury and Wounds, Degloving Injuries, Pressure Ulcers, Bedsores, Decubitus Ulcer

In brief

The proposed registry Sponsor (Siddhey LLC) will collect data on various wound treatments in real life settings. Data collection will facilitate the analysis of the safety and efficacy of wound treatments.

Key facts

Study ID

NCT06328010

Run by

Siddhey LLC

People needed

5000

Starts

2024-04-01

Expected to finish

2030-06-30

Last updated by the study team

2026-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is male or female ≥18 years of age.
• 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.
• Subject has clinical documentation of no visible wound improvement in the wound after 4 weeks of standard of care therapy.
• Study wound is a minimum of 1 cm2 at Visit 1.
• The subject is able and willing to follow the protocol requirements.
• The subject has signed the informed consent form.
• 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.

You may not qualify if…

• Subject has a known life expectancy < 1 year.
• Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver, or pulmonary disease, lupus, palliative care or sickle cell anemia.
• Subject currently being treated for an active malignant disease or subjects with a history of malignancy within the wound.
• Known contraindications to advance therapy tissues or products.
• 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.
• Affected extremity requiring hyperbaric oxygen during the study or within 2 weeks of Visit 1.
• Known HbA1c >12%.
• Subjects who are pregnant or breastfeeding.

Where it is running

• Pulse Cardiovascular Institute — Scottsdale, Arizona, United States
• Metro Foot & Ankle — Tempe, Arizona, United States
• Pima Foot and Ankle Surgery LLC — Tucson, Arizona, United States
• Signature Health Medical Group — Riverside, California, United States
• The Schottenstein Center — Hallandale, Florida, United States
• PerfectFeetCare Podiatry Centers — Hialeah, Florida, United States
• The Schottenstein Center — Miami, Florida, United States
• PerfectFeetCare Podiatry Centers — Miami, Florida, United States
• Wigley Feet — North Miami Beach, Florida, United States
• Rubin Foot & Ankle — Naperville, Illinois, United States
• The Rache Clinic — Las Vegas, Nevada, United States
• Richard C. Galperin, DPM, PA — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.