Clinical Registry Collecting Real World Evidence on Wound Care Treatments

NCT06328010 | Enrolling By Invitation DMC FDA Drug

• 1 other identifier: SIDDXAC02
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 12

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.

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

Keywords

Wound; DFU - Diabetic Foot Ulcer; VLU - Venous Leg Ulcer; Post Surgical; Trauma; Chronic Wound; MOHS - Mohs Micrographic Surgery; Non-Healing Wound

Outcome Measures

Primary Outcomes (2)

• Percentage wound area reduction over time while receiving study product using wound imaging device software or measurement scale

  Analysis will be based on product type (e.g., hydrocolloid, amniotic-based, etc.) and wound type (e.g., DFU, VLU, etc.)

  Up to 12 weeks

• 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)

  Note: Analysis will be based on product type (e.g., hydrocolloid, amniotic-based, etc.) and wound type (e.g., DFU, VLU, etc.)

  Up to 12 weeks

Secondary Outcomes (3)

• 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

Other Outcomes (8)

• Care setting analysis for each type of care setting, the number of wounds per type of wound and severity of wound per year

  Up to 12 weeks

• Care setting analysis for the duration of stay of wound (weeks) per type of admission

  Up to 12 weeks

• Economic comparison of treatment cost of wounds treated with Advanced biological/synthetic grafts. versus wounds treated with other treatments using classifications of wound type and medical center

  Up to 12 weeks

Study Arms (1)

Wound Treatment

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

Combination Product: Various types of wound care treatments

Interventions

Various types of wound care treatments 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

Wound Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with wounds/injuries

You 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 may not qualify 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.

Sponsors & Collaborators

• Siddhey LLC: lead
• Acesso Biologics: collaborator
• New Horizon Medical Solutions: collaborator

Study Sites (12)

Pulse Cardiovascular Institute

Scottsdale, Arizona, 85251, United States

Location

Metro Foot & Ankle

Tempe, Arizona, 85282, United States

Location

Pima Foot and Ankle Surgery LLC

Tucson, Arizona, 85718, United States

Location

Signature Health Medical Group

Riverside, California, 92503, United States

Location

The Schottenstein Center

Hallandale, Florida, 33009, United States

Location

PerfectFeetCare Podiatry Centers

Hialeah, Florida, 33012, United States

Location

The Schottenstein Center

Miami, Florida, 33137, United States

Location

PerfectFeetCare Podiatry Centers

Miami, Florida, 33175, United States

Location

Wigley Feet

North Miami Beach, Florida, 33162, United States

Location

Rubin Foot & Ankle

Naperville, Illinois, 60563, United States

Location

The Rache Clinic

Las Vegas, Nevada, 89147, United States

Location

Richard C. Galperin, DPM, PA

Dallas, Texas, 75208, United States

Location

Related Links

• Wound care management market overview, 2017, By GlobalData Healthcare
• Advanced Wound Care Market by Product Type (Infection Management, Exudate Management, Active Wound Care, Therapy Devices), Application (Chronic Wounds and Acute Wounds), End User (Hospitals and Community Centers)...

MeSH Terms

Conditions

Wounds and Injuries; Burns; Varicose Ulcer; Accidental Injuries; Degloving Injuries; Pressure Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Soft Tissue Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2030
• Last Updated: March 11, 2026

Record last verified: 2025-10

Locations

US (12)