What this study is
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.
What's being tested
- Various types of wound care treatments
Intervention · COMBINATION PRODUCT
Treatments including, but not limited to: * Hydrocolloid * Foam * Alginate * Hydrogel * Collagen * Antimicrobial (e.g., silver, iodine) * Film * Composite * Negative Pressure (NPWT) * Amniotic-based
Study details
- Official title
- An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care Treatments From a Variety of Treatment Settings
- Sponsor
- Siddhey LLC
- Conditions
- 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
- Enrolling
- 5,000 people
- Starts
- 2024-04-01
- Est. completion
- 2030-06-30
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (12)
12 openPulse 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
Study team
Sponsor
Siddhey LLC
Study ID SIDDXAC02
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.