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Clinical Trials in the USA / NCT06328010
Enrolling by invitation Observational

Clinical Registry Collecting Real World Evidence on Wound Care Treatments

NCT06328010 · tracked via the Priya Life Science USA tracker
Sponsor
Siddhey LLC
Phase
Observational
Started
2024-04-01
Last updated
2026-03-11

Condition(s) studied

Wounds and InjuriesBurnsMohs SurgeryDiabetic Foot Ulcer MixedVenous Leg UlcerNon-healing WoundTrauma InjuryInjury and WoundsDegloving InjuriesPressure Ulcers, Bedsores, Decubitus Ulcer

Investigational drug(s) / intervention(s)

Various types of wound care treatments

Various types of wound care treatments: Treatments including, but not limited to: * Hydrocolloid * Foam * Alginate * Hydrogel * Collagen * Antimicrobial (e.g., silver, iodine) * Film * Composite * Negative Pressure (NPWT) * Amniotic-based

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (12)

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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06328010 on ClinicalTrials.gov ↗ ← All trials in the USA