Burns, Degloving Injuries, Diabetic Foot Ulcer Mixed, Injury and Wounds, Mohs Surgery, Non-healing Wound, Pressure Ulcers, Bedsores, Decubitus Ulcer, Trauma Injury, Venous Leg Ulcer, Wounds and Injuries
Conditions
Keywords
Wound, DFU - Diabetic Foot Ulcer, VLU - Venous Leg Ulcer, Post Surgical, Trauma, Chronic Wound, MOHS - Mohs Micrographic Surgery, Non-Healing Wound
Brief 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.
Detailed 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.
Interventions
COMBINATION_PRODUCTVarious 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
Sponsors
Siddhey LLC
Acesso Biologics
New Horizon Medical Solutions
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage wound area reduction over time while receiving study product using wound imaging device software or measurement scale | Up to 12 weeks | Analysis will be based on product type (e.g., hydrocolloid, amniotic-based, etc.) and wound type (e.g., DFU, VLU, etc.) |
| 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) | Up to 12 weeks | Note: Analysis will be based on product type (e.g., hydrocolloid, amniotic-based, etc.) and wound type (e.g., DFU, VLU, etc.) |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of wounds achieving complete closure over time | Up to 12 weeks |
| Time to achieve complete wound closure while receiving study product | Up to 12 weeks |
| Assessment of patient reported wound-related pain using a numeric pain rating scale of 0 (no pain) to 10 (worst possible pain) during study product application | Up to 12 weeks |
Countries
United States
Outcome results
None listed