Clinical Registry Collecting Real World Evidence on Wound Care Treatments (SIDDX)

Siddhey

Status: Invitation-only

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

Treatments: Combination Product: Various types of wound care treatments

Study type: Observational

Funder types: NETWORK; Industry; Other

Identifiers

NCT06328010

SIDDXAC02

Details and patient eligibility

About

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.

Full description

This clinical registry is an observational study to collect prospective and retrospective data on subjects' health, wounds and wound care procedures from medical centers, including skilled nursing facilities, hospitals, outpatient clinics, Home Health and any other medical environment where wounds are treated.

The registry will enroll data of up to 5000 subjects in up to 100 wound care locations. The dataset includes all wound and ulcer types. Investigators will follow Institutional standards for routine wound care practices. The study products supplied through this study will be applied to the wounds as an adjunct to the standard of care treatment.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

5,000 participants in 1 patient group

Wound Treatment

Description:

Interventions are at the discretion of treating clinicians and include standard and advanced wound therapies.

Treatment:

Combination Product: Various types of wound care treatments