An observational study in Wounds and Injuries, Burns and Mohs Surgery, sponsored by Siddhey LLC. Enrolling by invitation at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Siddhey LLC · Observational
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.
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.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 64 across 163 observational studies indexed under Burns.
Browse Burns studies →This is the only study on the registry with Siddhey LLC as lead sponsor.
Compared within Burns, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Wounds and Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Adults with wounds/injuries
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Interventions are at the discretion of treating clinicians and include standard and advanced wound therapies.
Combination Product: Various 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
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.)
Time frame: 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.)
Time frame: Up to 12 weeks
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
Care setting analysis for each type of care setting, the number of wounds per type of wound and severity of wound per year
example: 20 severe DFUs per year
Time frame: Up to 12 weeks
Care setting analysis for the duration of stay of wound (weeks) per type of admission
Time frame: 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
Time frame: Up to 12 weeks
Incidence of infection
Time frame: Up to 12 weeks
Incidence of wound recurrence
Time frame: Up to 1 year
Number of treatment applications
Time frame: Up to 12 weeks
Percentage of wounds that closed during study product application that had previous therapy failure
Time frame: Up to 12 weeks
Proportion of subjects adherent to standard of care therapy
example: compression or offloading compliance as determined by the Investigator at each study visit
Time frame: Up to 12 weeks
Plan to share: Undecided — Data collected and analyzed will be marketed to researchers and manufacturers.
Started Apr 2024 (actual). Primary completion is estimated for Dec 2028, 56 months after the start.
Of 68 observational studies under Burns, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 56. This study's planned 56 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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