Clinical Registry Collecting Real World Evidence on Wound Care Treatments (NCT06328010) | Clinical Trial Compass
By InvitationNot Applicable
Clinical Registry Collecting Real World Evidence on Wound Care Treatments
United States5,000 participantsStarted 2024-04-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Percentage wound area reduction over time while receiving study product using wound imaging device software or measurement scale
Timeframe: Up to 12 weeks
2
Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events (AEs) related to wounds, and device-related adverse events (DRAEs)
. 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.