Wounds and InjuriesSIDDXNCT06328010
Clinical Registry Collecting Real World Evidence on Wound Care Treatments
An observational study of Wounds and Injuries and Burns, run by Siddhey LLC at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries, Burns, Mohs Surgery
- What is being tested?
- Various types of wound care treatments
- How many people
- 5,000 participants
- Where
- 12 sitesUnited States
- Study dates
- 1 Apr 2024to 30 Jun 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with wounds/injuries
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites
Richard C. Galperin, DPM, PA
Dallas, Texas, 75208
The Schottenstein Center
Hallandale, Florida, 33009
PerfectFeetCare Podiatry Centers
Hialeah, Florida, 33012
The Rache Clinic
Las Vegas, Nevada, 89147
The Schottenstein Center
Miami, Florida, 33137
PerfectFeetCare Podiatry Centers
Miami, Florida, 33175
Rubin Foot & Ankle
Naperville, Illinois, 60563
Wigley Feet
North Miami Beach, Florida, 33162
Signature Health Medical Group
Riverside, California, 92503
Pulse Cardiovascular Institute
Scottsdale, Arizona, 85251
Metro Foot & Ankle
Tempe, Arizona, 85282
Pima Foot and Ankle Surgery LLC
Tucson, Arizona, 85718
About this study
Official title: An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care Treatments From a Variety of Treatment Settings
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.
Read the 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.
- Conditions
- Wounds and Injuries, Burns, Mohs Surgery, Diabetic Foot Ulcer Mixed, Venous Leg Ulcer, Non-healing Wound
- Being tested
- Various types of wound care treatments
- Keywords
- Wound, DFU - Diabetic Foot Ulcer, VLU - Venous Leg Ulcer, Post Surgical, Trauma, Chronic Wound, MOHS - Mohs Micrographic Surgery, Non-Healing Wound
- Medical subject headings
- Wounds and Injuries, Burns, Varicose Ulcer, Accidental Injuries, Degloving Injuries, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Various types of wound care treatmentsCombination 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 group | Role | What they receive |
|---|---|---|
| Wound Treatment | Interventions are at the discretion of treating clinicians and include standard and advanced wound therapies. Receives: Combination Product: Various types of wound care treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.)
Measured: Up to 12 weeks
Secondary outcomes (3)
Proportion of wounds achieving complete closure over time
Measured: Up to 12 weeks
Time to achieve complete wound closure while receiving study product
Measured: 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
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Apr 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Siddhey LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acesso Biologics, New Horizon Medical Solutions
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328010
- Sponsor's protocol ID
- SIDDXAC02
- Acronym
- SIDDX
- Status last verified
- Oct 2025
- First submitted
- 18 Mar 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data collected and analyzed will be marketed to researchers and manufacturers.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care Treatments From a Variety of Treatment Settings
- ClinicalTrials.gov ID
- NCT06328010
- Acronym / sponsor ID
- SIDDX / SIDDXAC02
- Conditions
- Wounds and Injuries, Burns, Mohs Surgery, Diabetic Foot Ulcer Mixed, Venous Leg Ulcer, Non-healing Wound
- Keywords
- Wound, DFU - Diabetic Foot Ulcer, VLU - Venous Leg Ulcer, Post Surgical, Trauma, Chronic Wound, MOHS - Mohs Micrographic Surgery, Non-Healing Wound
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Siddhey LLCIndustry (pharma, biotech, devices)
- Collaborators
- Acesso Biologics, New Horizon Medical Solutions
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wound Treatment | – | Combination Product: Various types of wound care treatmentsInterventions are at the discretion of treating clinicians and include standard and advanced wound therapies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with wounds/injuries
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Various types of wound care treatmentsTreatments including, but not limited to: * Hydrocolloid * Foam * Alginate * Hydrogel * Collagen * Antimicrobial (e.g., silver, iodine) * Film * Composite * Negative Pressure (NPWT) * Amniotic-based | Combination product | Wound Treatment |
Primary outcome
Percentage wound area reduction over time while receiving study product using wound imaging device software or measurement scale
Time frame: 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)
Time frame: 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.)
3 secondary outcomes
Proportion of wounds achieving complete closure over time
Time frame: Up to 12 weeks
Time to achieve complete wound closure while receiving study product
Time frame: 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
Time frame: Up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Wound care management market overview, 2017, By GlobalData HealthcareLink provided by the sponsor.
- 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)...Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Data collected and analyzed will be marketed to researchers and manufacturers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Injuries and Burns, run by Siddhey LLC at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage wound area reduction over time while receiving study product using wound imaging device software or measurement scale (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.