Clinical registry collecting real-world evidence on wound care treatments (SIDDX)
| ISRCTN | ISRCTN96261955 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96261955 |
| ClinicalTrials.gov number | NCT06328010 |
| Secondary identifying numbers | Pro00070536 |
- Submission date
- 06/06/2024
- Registration date
- 18/06/2024
- Last edited
- 26/07/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
This study will collect data on various wound treatments and their related wound-healing processes in real-life settings.
Who can participate?
All adults requiring wound care
What does the study involve?
Continuation of wound treatment as dictated by the treating physician
What are the possible benefits and risks of participating?
It is hoped that these results will help future participants benefit from an improved wound treatment regime and healing times. Possible risks are allergic or autoimmune response to the biological/synthetic grafts used, since we are strictly observing treatments, the treating providers will be strongly requested to observe for such an incident and report AE/SAE. All products observed are mandated to have FDA clearance, as such risk to the patient is minimal.
Where is the study run from?
Siddhey LLC (United States of America)
When is the study starting and how long is it expected to run for?
April 2024 to March 2029
Who is funding the study?
Siddhey LLC (United States of America)
Who is the main contact?
Mr Chinmay Chauhan (MBA, RN-BSN, BSBE), ChinmayC@siddhey.com
Contact information
Public, Scientific, Principal Investigator
215 E Warm Springs Rd, STE 108
Las Vegas
89119
United States of America
| Phone | +1 2245581092 |
|---|---|
| chinmayc@siddhey.com |
Study information
| Study design | Multicenter observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Care home, GP practice, Home, Hospital, Medical and other records, University/medical school/dental school |
| Study type | Quality of life, Treatment, Efficacy |
| Participant information sheet | 45580_PIS_08Jan0824.pdf |
| Scientific title | An observational clinical registry to collect safety and efficacy data on wound care treatments from a variety of treatment settings |
| Study acronym | SIDDX |
| Study objectives | The study's primary objection is to collate an observational clinical registry to collect treatment outcomes after biological and synthetic amnion grafts. It is hypothesised that wound treatment will reduce healing time by >40% |
| Ethics approval(s) |
Approved 27/09/2023, Advarra IRB (6100 Merriweather Dr., Suite 600, Columbia, MD 21044, United States of America; +1 877-992-4724; adviser@advarra.com), ref: SIDDXAC02 |
| Ethics approval additional information | The study will not challenge the treatment practice of physicians treating wound (+), and will only collect data on treatment which has been agreed upon by the physician and patients. |
| Health condition(s) or problem(s) studied | Improving heal rate in wound care |
| Intervention | This is a multicenter observational study enrolling deidentified patients that will collect data on the healing rate of wounds and wound care between the standard of care and many advanced therapeutic interventions. Physicians, APRNs, and PAs treating patients for any type of "wound" care resulting from conditions such as diabetes, vascular insufficiency, dermatological conditions, or from trauma, surgical/post-surgical events, chemotherapy, burns, and degloving will be observed. The two treatment methods observed will be standard of care (SOC) and treatment with biological or synthetic grafts (advanced treatment modality). The timeframe of 12 weeks (1/week 10 treatment = 10 weeks and 2 weeks post closure/end of 10 weeks follow up) at maximum will be observed. This data will be analyzed to determine the rate of healing via the use of advanced treatment modalities. Since the observational study will not dictate therapy, and very few IC/EC this will be as close to real-world evidence data that can be gathered. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Acesso, NeoStim, Surgraft biological/synthetic grafts |
| Primary outcome measure | The rate of wound healing measured using data documented during every treatment visit (once per week), first is 20% healed, next is 50% compared to week 1, and lastly 100% |
| Secondary outcome measures | The rate of wound healing measured using data collected every week for a maximum of 10 weeks to achieve wound closure (100%), based on the assumption of one treatment (encounter) per week |
| Overall study start date | 14/02/2023 |
| Completion date | 31/03/2030 |
Eligibility
| Participant type(s) | Patient, Population |
|---|---|
| Age group | Adult |
| Lower age limit | 21 Years |
| Sex | Both |
| Target number of participants | 4000 |
| Key inclusion criteria | 1. Aged ≥18 years of age 2. Ulcer or a chronic wound, including an ulcer (diabetic foot ulcer, venous stasis ulcer, etc.), injury (trauma, post-surgical, Mohs surgery treatment), burns injury, and acute/chronic wounds 3. Subject agrees to the use of his health data, including photos of his wound in analysis and publications 4. The subject/subject's legally authorised representative (LAR) must be able to read and understand English and/or Spanish |
| Key exclusion criteria | The subject/subject's legally authorised representative (LAR) is unable to read and understand English or Spanish. |
| Date of first enrolment | 01/04/2024 |
| Date of final enrolment | 30/06/2029 |
Locations
Countries of recruitment
- United States of America
Study participating centre
West Hills
91307
United States of America
Sponsor information
Research organisation
215 E Warm Springs Rd, STE 108
Las Vegas
89119
United States of America
| Phone | None provided |
|---|---|
| chinmayc@siddhey.com | |
| Website | https://www.siddhey.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 14/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current plan is to perform QUARTERLY publications starting October 2024, leading up to interim analysis reports at 250 patient marks. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Mr Chinmay Chauhan (MBA, RN-BSN, BSBE), ChinmayC@siddhey.com. IPD and analytics will be stored in a secured web server located at https://www.siddhey.com and will only be made available to contracted manufacturers and any healthcare governing bodies. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 08/01/2008 | 18/06/2024 | No | Yes | |
| Protocol file | 27/09/2023 | 18/06/2024 | No | No | |
| Other files | Informed Consent Form | 10/07/2024 | 16/07/2024 | No | No |
Additional files
- 45580_Protocol_27sept2023.pdf
- 45580_PIS_08Jan0824.pdf
- ISRCTN96261955_ICF_10Jul24.pdf
- Informed Consent Form
Editorial Notes
26/07/2024: Internal review.
16/07/2024: The following changes were made to the study record:
1. Informed consent form uploaded.
2. The public title was changed from 'A registry to collect data on wound care in medical centers' to 'Clinical registry collecting real-world evidence on wound care treatments (SIDDX)'.
3. The scientific title was changed from 'An observational clinical registry to collect safety and efficacy data on wound care in medical centers' to 'An observational clinical registry to collect safety and efficacy data on wound care treatments from a variety of treatment settings'.
17/06/2024: Study's existence confirmed by the Advarra Center for IRB Intelligence (CIRBI) Platform.
